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.

13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11216 Chemistry devices
3001–3025 of 11216
Cleared Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · Helena Laboratories
CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes · 45d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · DiaSorin, Inc.
MRG · System, Test, Vitamin D · 110d
Cleared Mar 23, 2002
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596 · Diamond Diagnostics, Inc.
JIT · Calibrator, Secondary · 29d
Cleared Mar 21, 2002
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET
K020450 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 38d
Cleared Mar 21, 2002
URS-IG (GLUCOSE TEST)
K020175 · Teco Diagnostics
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 63d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · Roche Diagnostics Corp.
CGA · Glucose Oxidase, Glucose · 94d
Cleared Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
K020217 · Bayer Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 52d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 25d
Cleared Mar 08, 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · Quantimetrix Corp.
JHO · Electrophoretic Separation, Lipoproteins · 122d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 10d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 45d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282 · Jas Diagnostics, Inc.
JFJ · Catalytic Methods, Amylase · 31d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295 · Nova Biomedical Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 62d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 176d
Cleared Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
K013874 · Unipath , Ltd.
CEP · Radioimmunoassay, Luteinizing Hormone · 90d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 64d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 65d
Cleared Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · Phoenix Diagnostics, Inc.
CGZ · Electrode, Ion-specific, Chloride · 19d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · Phoenix Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · Roche Molecular Systems, Inc.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 150d
Cleared Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · Beckman Coulter, Inc.
MRR · System, Test, Low Density, Lipoprotein · 46d
Cleared Jan 28, 2002
WIENER LAB. ALP 405
K013983 · Wiener Laboratories Saic
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 56d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · Jas Diagnostics, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 52d
Cleared Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp.
DIH · Colorimetry, Cholinesterase · 66d
Cleared Jan 18, 2002
N LATEX LP(A)
K013128 · Dade Behring, Inc.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 121d

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All categories 11216 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 461 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143