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
2326–2350 of 13257
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 109d
Cleared Jul 06, 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 70d
Cleared Jul 06, 2006
PRODIGY
K053593 · Diagnostic Devices, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 195d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 48d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 10d
Cleared Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics
CGR · Radioimmunoassay, Cortisol · 130d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 60d
Cleared Jun 23, 2006
CREATININE
K061193 · Abbott Laboratories, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 56d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · Mizuho USA, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 84d
Cleared Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · Drew Scientific , Ltd.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 112d
Cleared Jun 16, 2006
EZ SMART-168 GLUCOSE MONITORING SYSTEM
K052818 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 255d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · Ortho-Clinical Diagnostics, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 21d
Cleared Jun 15, 2006
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 122d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories
MMI · Immunoassay Method, Troponin Subunit · 76d
Cleared Jun 13, 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · E-San Limited
NBW · System, Test, Blood Glucose, Over The Counter · 32d
Cleared Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
K061296 · Diazyme Laboratories
LPS · Urinary Homocystine (nonquantitative) Test System · 35d
Cleared Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · Iris International, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 131d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
K060632 · Ortho-Clinical Diagnostics, Inc.
NBC · Test, Natriuretic Peptide · 89d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · Acro Biotech, LLC
DJC · Thin Layer Chromatography, Methamphetamine · 222d
Cleared Jun 05, 2006
GLUCOPACK
K052469 · Healthpia America Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 270d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 25d
Cleared Jun 02, 2006
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
K061073 · Taidoc Technology Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 46d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · Dade Behring, Inc.
JIS · Calibrator, Primary · 27d
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · Microgenics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 32d
Cleared May 30, 2006
NOD CHEMISTRY CONTROL
K060850 · Bioresource Technology, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 63d

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