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
11208 Chemistry devices
2651–2675 of 11208
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 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
Cleared Mar 08, 2004
VITALAB MAGNESIUM REAGENT
K040508 · Clinical Data, Inc.
JGJ · Photometric Method, Magnesium · 10d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467 · Clinical Data, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 13d
Cleared Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 25d
Cleared Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 26d
Cleared Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455 · Cliniqa Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 11d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · Bio-Rad Laboratories, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Mar 04, 2004
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060 · Diamond Diagnostics, Inc.
JIT · Calibrator, Secondary · 157d
Cleared Mar 02, 2004
A1C-CELLULAR
K040025 · Streck Laboratories, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 55d
Cleared Feb 27, 2004
RANDOX URIC ACID
K033278 · Randox Laboratories, Ltd.
CDO · Acid, Uric, Uricase (u.v.) · 140d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 33d
Cleared Feb 23, 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 38d

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All categories 11208 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 459 JJX Single (specified) Analyte Controls (assayed And Unassayed) 383 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 217 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