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
2226–2250 of 13257
Cleared Dec 19, 2006
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
K062838 · Ortho-Clinical Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 89d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
K063591 · Ortho-Clinical Diagnostics, Inc.
JFY · Enzymatic Method, Creatinine · 14d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
K062460 · Ortho-Clinical Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 114d
Cleared Dec 15, 2006
SDI CA480 CLINICAL CHEMISTRY SYSTEM
K061879 · Hemodiagnostica, LLC
CFR · Hexokinase, Glucose · 165d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · Abbott Diabetes Care, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 90d
Cleared Dec 05, 2006
URITEST 10 URINALYSIS REAGENT STRIPS
K052719 · Arj Medical, Inc.
CDM · Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) · 432d
Cleared Dec 01, 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · Bio-Rad Laboratories, Inc.
LCP · Assay, Glycosylated Hemoglobin · 22d
Cleared Dec 01, 2006
MISSION TRINITY B
K062674 · Diamond Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 84d
Cleared Nov 29, 2006
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581 · Olympus America, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 90d
Cleared Nov 22, 2006
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
K063212 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 30d
Cleared Nov 22, 2006
CALCIUM
K062855 · Abbott Laboratories
CJY · Azo Dye, Calcium · 58d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc.
DJR · Enzyme Immunoassay, Methadone · 78d
Cleared Nov 22, 2006
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
K062593 · Compass Bioscience
JJY · Multi-analyte Controls, All Kinds (assayed) · 82d
Cleared Nov 22, 2006
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
K062467 · Axis-Shield Diagnostics, Ltd.
CDD · Radioassay, Vitamin B12 · 90d
Cleared Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · Bayer Healthcare, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 104d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
K062094 · Ortho-Clinical Diagnostics, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 121d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 124d
Cleared Nov 22, 2006
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
K061617 · Tianjin New Bay Bioresearch Co., Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 166d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062123 · Ortho-Clinical Diagnostics, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 114d
Cleared Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · Ortho-Clinical Diagnostics, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 28d
Cleared Nov 13, 2006
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
K062434 · Agamatrix
NBW · System, Test, Blood Glucose, Over The Counter · 84d
Cleared Nov 03, 2006
POLY-CHEM CREATININE
K061944 · Polymedco, Inc.
JFY · Enzymatic Method, Creatinine · 116d
Cleared Nov 01, 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · Nova Biomedical Corp.
CIG · Diazo Colorimetry, Bilirubin · 126d
Cleared Oct 30, 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024 · Lin-Zhi International, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 28d
Cleared Oct 30, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · Sentech Korea Corp.
DJZ · Devices, Breath Trapping, Alcohol · 115d

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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