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
2801–2825 of 13257
Cleared Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727 · Nichols Institute Diagnostics
CEW · Radioimmunoassay, Parathyroid Hormone · 146d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc.
LCP · Assay, Glycosylated Hemoglobin · 13d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 16d
Cleared Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
K040692 · Olympus America, Inc.
JIT · Calibrator, Secondary · 22d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 78d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 58d
Cleared Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
K040535 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 27d
Cleared Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
K040670 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 10d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 15d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
K040226 · Wako Chemicals USA, Inc.
JIT · Calibrator, Secondary · 52d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 50d
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181 · Beckman Coulter, Inc.
JKC · Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) · 57d
Cleared Mar 24, 2004
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
K032657 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 209d
Cleared Mar 18, 2004
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · Clinical Data, Inc.
CIG · Diazo Colorimetry, Bilirubin · 8d
Cleared Mar 18, 2004
ZAP HCG TEST, MODEL 8001
K033297 · Zbx Corporation
JHI · Visual, Pregnancy Hcg, Prescription Use · 156d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351 · Randox Laboratories, Ltd.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
K032936 · Stanbio Laboratory
JIX · Calibrator, Multi-analyte Mixture · 172d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc.
JFJ · Catalytic Methods, Amylase · 9d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 34d
Cleared Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471 · Olympus America, Inc.
JIT · Calibrator, Secondary · 15d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · Bio-Rad Laboratories, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 34d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · R&D Systems, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 71d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · Clinical Data, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 77d
Cleared Mar 10, 2004
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · Diagnostic Chemicals , Ltd.
JIF · Enzymatic Method, Ammonia · 83d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · Stanbio Laboratory
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 170d

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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 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 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