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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
2626–2650 of 13257
Cleared Feb 07, 2005
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · Phamatech, Inc.
DJG · Enzyme Immunoassay, Opiates · 95d
Cleared Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026 · Roche Diagnostics
JIX · Calibrator, Multi-analyte Mixture · 25d
Cleared Jan 31, 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460 · Olympus America, Inc.
JIX · Calibrator, Multi-analyte Mixture · 47d
Cleared Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
K043071 · Randox Laboratories, Ltd.
LCM · Enzyme Immunoassay, Phencyclidine · 80d
Cleared Jan 26, 2005
LDL-EX SEIKEN ASSAY KIT
K043264 · Denka Seiken Co., Ltd.
MRR · System, Test, Low Density, Lipoprotein · 63d
Cleared Jan 24, 2005
ARCHITECT STAT MYO IMMUNOASSAY
K042924 · Fisher Diagnostics
DDR · Myoglobin, Antigen, Antiserum, Control · 94d
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · Dade Behring, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 26d
Cleared Jan 10, 2005
ROCHE AMPLICHIP CYP450 TEST
K043576 · Roche Molecular Systems, Inc.
NTI · Drug Metabolizing Enzyme Genotyping Systems · 14d
Cleared Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 49d
Cleared Jan 07, 2005
CHEMVIEW-10
K042641 · Cenogenics Corp.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 102d
Cleared Jan 03, 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K042678 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 96d
Cleared Dec 29, 2004
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
K043378 · Drew Scientific , Ltd.
JIT · Calibrator, Secondary · 21d
Cleared Dec 29, 2004
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
K043167 · Phamatech, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 43d
Cleared Dec 27, 2004
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362 · Diagnostic Chemicals , Ltd.
KHS · Enzymatic, Carbon-dioxide · 118d
Cleared Dec 27, 2004
GENCHEM ELECTROLYTE BUFFER
K040977 · Genchem, Inc.
JGS · Electrode, Ion Specific, Sodium · 257d
Cleared Dec 27, 2004
GENCHEM CREATININE REAGENT
K040976 · Genchem, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 257d
Cleared Dec 27, 2004
GENCHEM CO2 ACID REAGENT
K040975 · Genchem, Inc.
JFL · Ph Rate Measurement, Carbon-dioxide · 257d
Cleared Dec 27, 2004
GLUCOSE OXIDASE, GLUCOSE
K040974 · Genchem, Inc.
CGA · Glucose Oxidase, Glucose · 257d
Cleared Dec 27, 2004
BUN REAGENT
K040973 · Genchem, Inc.
CDS · Electrode, Ion Specific, Urea Nitrogen · 257d
Cleared Dec 27, 2004
CALCIUM, AZO DYE REAGENT
K040972 · Genchem, Inc.
CJY · Azo Dye, Calcium · 257d
Cleared Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · Roche Diagnostics Corp.
CGN · Acid, Folic, Radioimmunoassay · 21d
Cleared Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · Olympus America, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 35d
Not Cleared Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
DEN040011 · Roche Molecular Systems, Inc.
NTI · Drug Metabolizing Enzyme Genotyping Systems · 3d
Cleared Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · Bayer Healthcare, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 21d
Cleared Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · Bayer Healthcare, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 37d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162