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
11204 Chemistry devices
2101–2125 of 11204
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
Cleared Oct 30, 2006
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
K061234 · Glucoplus, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 181d
Cleared Oct 23, 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 25d
Cleared Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
K062361 · Innovacon, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 70d
Cleared Oct 18, 2006
AMNIOSTAT-FLM-PG
K061549 · Irvine Scientific Sales Co., Inc.
JHG · Chromatographic Separation, Lecithin/sphingomyelin Ratio · 135d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668 · Aalto Scientific, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 38d
Cleared Oct 16, 2006
ABL8X7 FLEX
K051968 · Radiometer Medical Aps
CGL · Electrode, Ion Based, Enzymatic, Creatinine · 453d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 14d
Cleared Oct 13, 2006
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
K062808 · Catch Incorporated
LPS · Urinary Homocystine (nonquantitative) Test System · 24d
Cleared Oct 10, 2006
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
K062829 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 20d
Cleared Oct 05, 2006
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575 · Olympus America, Inc.
CJY · Azo Dye, Calcium · 120d
Cleared Oct 03, 2006
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · Quantimetrix Corp.
JJT · Enzyme Controls (assayed And Unassayed) · 19d
Cleared Oct 02, 2006
ABX PENTRA AMYLASE CP
K062180 · Horiba Abx
JFJ · Catalytic Methods, Amylase · 63d
Cleared Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · Maine Standards Co.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 35d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · Lin-Zhi International, Inc.
LAF · Gas Chromatography, Methamphetamine · 58d

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All categories 11204 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