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
191d
Avg (2y)
1976
Since
11203 Chemistry devices
2076–2100 of 11203
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 66d
Cleared Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
K063643 · Bio-Rad Laboratories Inc., Clinical Systems Divisi
LCP · Assay, Glycosylated Hemoglobin · 20d
Cleared Dec 27, 2006
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
K062555 · Visgeneer, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 119d
Cleared Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 89d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
K063543 · Roche Diagnostics Corp.
CIG · Diazo Colorimetry, Bilirubin · 28d
Cleared Dec 22, 2006
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
K063224 · Gentris Corporation
NZB · Quality Control Material, Genetics, Dna · 59d
Cleared Dec 22, 2006
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
K063057 · Diagnostic Products Corporation
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 78d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062285 · Ortho-Clinical Diagnostics, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 137d
Cleared Dec 20, 2006
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
K063068 · Arkray USA, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 75d
Cleared Dec 20, 2006
CORTISOL ELISA
K062626 · Ibl-Hamburg GmbH
CGR · Radioimmunoassay, Cortisol · 106d
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

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All categories 11203 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 247 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 175 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