Summary of NMPA Certified Clinical Mass Spectrometers

In recent years, with the continuous development of precision medicine, mass spectrometry technology, as a high-tech platform for precision diagnosis and treatment, has been increasingly applied in clinical settings. Although China started late compared to foreign countries, especially North America, the rapid increase in domestic demand for high-end medical technology and the expansion of investment channels have made mass spectrometry a rising star in the testing field, attracting significant industry attention in the past two years. From upstream instrument hardware manufacturers to midstream reagent kit developers, and downstream hospitals and third-party independent medical testing institutions, all have increased their investment in mass spectrometry-related fields.

Due to the sharp increase in domestic demand for mass spectrometry, major domestic and foreign mass spectrometry manufacturers have submitted their quality products to the National Medical Products Administration (NMPA, formerly CFDA) to better serve the clinical testing market. Some mass spectrometry instruments have already obtained NMPA certification and relevant medical device documentation.

The earliest approval for the application of mass spectrometry technology in clinical settings by the National Medical Products Administration was in 2008. To help everyone gain a more comprehensive understanding of the relevant information, we have compiled a summary of the mass spectrometers approved by the NMPA for clinical testing as of now, which includes a total of 10 domestic mass spectrometers, of which 3 have expired; and 13 imported mass spectrometers, of which 5 have expired. Details are as follows:

Summary Table of Domestic Medical Devices

Quadrupole Mass Spectrometry:

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Microbial or Nucleic Acid Mass Spectrometry (Time-of-Flight Mass Spectrometry), Breath Mass Spectrometry:

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Note: The red font indicates that the product has expired, and the same applies below.

Summary Table of Imported Medical Devices

Quadrupole Mass Spectrometry:

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Microbial or Nucleic Acid Mass Spectrometry(Time-of-Flight Mass Spectrometry):

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Product images and other information (excluding expired mass spectrometers, the order corresponds to the above table):

Domestic Mass Spectrometers

01

Name: Triple Quadrupole Mass Spectrometry Analysis System

Model: FH-6000MD

Registration Agency: Guangzhou Fenghua Bioengineering Co., Ltd.

Company Address: No. 6, Yinyi Street, Guangzhou Economic and Technological Development Zone

Agent:

Place of Production:

Structure Composition: Composed of ultra-high-performance liquid chromatography, triple quadrupole mass spectrometer, random software (including TraceFinder and RC PRO), manual injector (injection pump), switching/injection valve, and front pump (mechanical pump). Among them, the ultra-high-performance liquid chromatography mainly consists of a split injector, binary pump, and column temperature box.

Scope of Application: Mainly used in hospitals to analyze various compounds, including diagnostic indicators and therapeutic monitoring compounds, applicable for routine in vitro diagnostic applications.

Validity Period: 2018.08.27-2023.08.26

02

Name: Time-of-Flight Mass Spectrometer

Model: Clin-TOF-Ⅰ

Registration Agency: Beijing Yixin Bochuang Biotechnology Co., Ltd.

Company Address: Building B201, No. 1 Courtyard, Disheng East Road, Beijing Economic and Technological Development Zone

Agent:

Place of Production: Beijing

Structure Composition:

Scope of Application: Precise gene testing of circulating tumor DNA.

Validity Period: 2014.06.03-2019.06.02

03

Name: Time-of-Flight Mass Spectrometer

Model: Clin-TOF-Ⅱ

Registration Agency: Beijing Yixin Bochuang Biotechnology Co., Ltd.

Company Address: Building B201, No. 1 Courtyard, Disheng East Road, Beijing Economic and Technological Development Zone

Agent:

Place of Production: Beijing

Structure Composition:

Scope of Application: Detection of single nucleotide polymorphisms, gene mutation detection, DNA methylation detection, gene copy number identification.

Validity Period: 2016.11.01-2021.10.31

044

Name: Liquid Chip Time-of-Flight Mass Spectrometry System

Model: GT-7110

Registration Agency: Hangzhou Yicheng Modi Biotechnology Co., Ltd.

Company Address: No. 2, Science Park Road, Baiyang Street, Hangzhou Economic and Technological Development Zone, 8th Floor, Unit 07-12

Agent:

Place of Production: Hangzhou

Structure Composition: Host, computer, analysis software (release version: V1.0), steel chip.

Scope of Application: Microbial identification, protein analysis, etc.

Validity Period: 2017.04.10- 2022.04.09

05

Name: Liquid Chip Time-of-Flight Mass Spectrometry System (Protein Fingerprinting Instrument)

Model: Type I

Registration Agency: Huzhou Saierdi Biomedical Technology Co., Ltd.

Company Address:

Agent:

Place of Production: Huzhou

Structure Composition: Host, computer, analysis software, steel chip.

Scope of Application: Qualitative detection of β2-microglobulin in urine.

Validity Period: 2015.12.17- 2020.12.16

06

Name: Time-of-Flight Mass Spectrometry Detection System

Model: DR MassARRAY

Registration Agency: Guangzhou Darui Biotechnology Co., Ltd.

Company Address: No. 404, Self-compiled No. 2, Lizhishan Road, Guangzhou High-tech Industrial Development Zone

Agent:

Place of Production: Guangzhou

Structure Composition: Spotting module, analysis module, and random software. The analysis module includes ion source, mass analyzer, detector, vacuum system, and control system.

Scope of Application: In vitro diagnostic equipment for detecting SNPs on the DNA of living organisms, currently only used in conjunction with the testing reagents for hereditary deafness gene mutation detection.

Validity Period: 2018.09.30 – 2023.09.29

07

Name: Fully Automatic Microbial Mass Spectrometry Detection System

Model: Autof ms1000

Registration Agency: Antu Experimental Instruments (Zhengzhou) Co., Ltd.

Company Address: No. 199, 15th Avenue, Zhengzhou Economic and Technological Development Zone

Agent:

Place of Production: Zhengzhou

Structure Composition: Composed of specimen plate, control mass spectrometer host data workstation, and mass spectrometer host (MALDI-TOF ion source and time-of-flight mass detector, vertical ion flight tube, vacuum system), software (including database).

Scope of Application: Identification tests for separated bacteria and fungi using the MALDI-TOF mass spectrometry method.

Validity Period: 2018.4.28 – 2023.04.27

Imported Mass Spectrometers

01

Name: Liquid Chromatography Tandem Mass Spectrometry Detection System (LC/MS/MS System)

Model: AB SCIEX Triple QuadTM 4500MD

Registration Agency: AB Sciex Pte.Ltd.

Agent: Shanghai Aibocai Analysis Instrument Trading Co., Ltd.

Place of Production: Singapore

Structure Composition: The product mainly consists of a triple quadrupole mass spectrometer (4500MD), high-performance liquid chromatography (Jasper™), and software components, including Analyst®MD software (version number: 1.6), Cliquid®MD software (version number: 3.3), and MultiQuant™MD software (version number: 3.0).

Scope of Application: The product is based on liquid chromatography-mass spectrometry combined technology, using liquid chromatography as the separation system and mass spectrometry as the detection system, used in conjunction with detection reagents for qualitative or quantitative analysis of inorganic or organic compounds from human blood samples, including diagnostic indicators (endogenous substances: amino acids, vitamins, hormones) and therapeutic monitoring compounds (exogenous substances: therapeutic/toxic drugs).

Validity Period: 2017.06.02 – 2022.06.01

02

Name: Liquid Chromatography Tandem Mass Spectrometry Detection System (LC/MS/MS System)

Model: Triple Quadrupole Mass Spectrometer (LC/MS/MS System)

Registration Agency: AB Sciex Pte.Ltd.

Agent: Shanghai Aibocai Analysis Instrument Trading Co., Ltd.

Place of Production : Singapore

Structure Composition: Mainly consists of a triple quadrupole mass spectrometer, ion source, integrated switching valve, integrated injection pump, random software Analyst MD and Cliquid MD.

Scope of Application: Mainly used to determine inorganic or organic compounds (such as lead, mercury, and drug components) in human samples, primarily for qualitative and quantitative analysis of endogenous substances such as amino acids, carnitine, and sugars, and exogenous substances such as drugs.

Validity Period: 2014.09.01 –2019.08.31

03

Name: Ultra-High-Performance Liquid Chromatography Tandem Mass Spectrometry System (ACQUITY UPLC I-Class IVD / Xevo TQ-D IVD System)

Model: ACQUITY I-X

Registration Agency: Waters Corporation

Agent: Waters Technologies (Shanghai) Co., Ltd.

Place of Production: USA

Structure Composition: Mainly consists of ultra-high-performance liquid chromatography: binary solvent manager, sample manager, high-temperature chromatography column heating device, sample organizer (optional), triple quadrupole mass spectrometer, MassLynx software.

Scope of Application: Mainly used to analyze various compounds, including diagnostic indicators and therapeutic monitoring compounds, applicable for routine in vitro diagnostic applications.

Validity Period: 2015.06.05 –2020.06.04

04

Name: Ultra-High-Performance Liquid Chromatography Tandem Mass Spectrometry System

Model: ACQUITY I-S

Registration Agency: Waters Corporation

Agent: Waters Technologies (Shanghai) Co., Ltd.

Place of Production: USA

Structure Composition: Mainly consists of ultra-high-performance liquid chromatography, triple quadrupole mass spectrometer, software, among which the ultra-high-performance liquid chromatography mainly includes: sample manager, high-temperature chromatography column temperature control box, binary solvent manager, sample organizer (optional).

Scope of Application: Mainly used to analyze various compounds, including diagnostic indicators and therapeutic monitoring compounds, applicable for routine in vitro diagnostic applications.

Validity Period: 2015.02.09 –2020.02.08

05

Name: High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Model: LCMS-8040CL

Registration Agency: SHIMADZU CORPORATION

Agent: Shimadzu Corporation Management (China) Co., Ltd.

Place of Production: USA

Structure Composition: Mainly consists of high-performance liquid chromatography, triple quadrupole mass spectrometer, LabSolutions LCMS software (version number: 5).

Scope of Application: Based on chromatography and mass spectrometry principles, used in conjunction with detection reagents for qualitative or quantitative analysis of analytes in human blood samples, including quantitative analysis of organic small molecules (amino acids, carnitine, vitamins).

Validity Period: 2018.05.23 –2023.05.22

06

Name: High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Model: LCMS-8050CL

Registration Agency: SHIMADZU CORPORATION

Agent: Shimadzu Corporation Management (China) Co., Ltd.

Place of Production: USA

Structure Composition: Mainly consists of high-performance liquid chromatography, triple quadrupole mass spectrometer, LabSolutions LCMS software (version number: 5).

Scope of Application: Based on chromatography and mass spectrometry principles, used in conjunction with detection reagents for qualitative or quantitative analysis of analytes in human blood samples, including qualitative and quantitative analysis of organic small molecules (amino acids, carnitine, vitamins).

Validity Period: 2018.05.23 –2023.05.22

07

Name: Fully Automatic Biological Mass Spectrometry Detection System (IVD MALDI Biotyper System)

Model: Microflex LT/SH

Registration Agency: Bruker Daltonik GmbH

Agent: Bruker (Beijing) Technology Co., Ltd.

Place of Production: Germany

Structure Composition: Composed of microflex LT/SH mass spectrometer configured with a Bruker micro-detection ion source, a vertical ion flight tube with optional reflector, dual microchannel plate detector, control device flexControl (release version: 3.4) software, IVD MBT (release version: 2.3) software and database for comparing sample mass spectrometry graphs.

Scope of Application: Identification of unknown microorganisms such as bacteria and yeast at the species level using MALDI-TOF (Matrix-Assisted Laser Desorption Ionization Time-of-Flight) mass spectrometry technology.

Validity Period: 2018.05.09 –2023.05.08

08

Name: Fully Automatic Microbial Mass Spectrometry Detection System (VITEK MS)

Model: VITEK MS

Registration Agency: bioMerieux SA

Agent: Merieux Diagnostics (Shanghai) Co., Ltd.

Place of Production : France

Structure Composition: Mainly consists of VITEK MS preprocessing station, VITEK MS data acquisition station, VITEK MS instrument, Myla, VITEK MS-DS.

Scope of Application: Identification tests for bacteria and fungi using the MALDI mass spectrometry method.

Validity Period: 2016.07.06 –2020.07.05

If there are any omissions or deficiencies, please supplement in the comment area!

Source: Clinical Mass Spectrometry Detection | Author: ClinicalMS

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