FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
676–700 of 3201
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · Dade Behring, Inc.
JFY · Enzymatic Method, Creatinine · 65d
Cleared Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · bioMerieux, Inc.
MMI · Immunoassay Method, Troponin Subunit · 414d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 78d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc.
CDD · Radioassay, Vitamin B12 · 195d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · Roche Diagnostics Corp.
JGQ · Turbidimetric, Total Protein · 31d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 48d
Cleared Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · Dade Behring, Inc.
NBC · Test, Natriuretic Peptide · 45d
Cleared Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · Dade Behring, Inc.
NBC · Test, Natriuretic Peptide · 36d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · Roche Diagnostics Corp.
CEW · Radioimmunoassay, Parathyroid Hormone · 121d
Cleared Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
K071002 · Beckman Coulter, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 73d
Cleared Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · Dade Behring, Inc.
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 77d
Cleared Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · Beckman Coulter, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 25d
Cleared Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · Beckman Coulter, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 25d
Cleared Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277 · Beckman Coulter, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 25d
Cleared May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 85d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 266d
Cleared May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
K070626 · Beckman Coulter, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 59d
Cleared Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K063663 · Dade Behring, Inc.
DDG · Transferrin, Antigen, Antiserum, Control · 103d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · Roche Diagnostics Corp.
CEW · Radioimmunoassay, Parathyroid Hormone · 39d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 56d
Cleared Mar 19, 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 90d
Cleared Feb 23, 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
K063754 · Dade Behring, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 66d
Cleared Feb 23, 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063608 · Dade Behring, Inc.
MSJ · Apolipoproteins · 81d
Cleared Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 16d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 169d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38