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
2301–2325 of 13257
Cleared Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
K060325 · Horiba Abx
CIG · Diazo Colorimetry, Bilirubin · 188d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 42d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 51d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559 · Acon Laboratories Co.
CDM · Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) · 67d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 156d
Cleared Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
K061107 · Thermo Electron OY
CEM · Electrode, Ion Specific, Potassium · 110d
Cleared Aug 08, 2006
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · Horiba Abx
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 181d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · Dade Behring, Inc.
JIY · Photometric Method, Iron (non-heme) · 42d
Cleared Aug 04, 2006
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
K061730 · Osmetech, Inc.
CEM · Electrode, Ion Specific, Potassium · 45d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 47d
Cleared Jul 28, 2006
ACTIVE RENIN IRMA
K061758 · Diagnostic Systems Laboratories, Inc.
CIB · Radioimmunoassay, Angiotensin I And Renin · 36d
Cleared Jul 25, 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
K060793 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 124d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 36d
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 43d
Cleared Jul 21, 2006
QMS TOBRAMYCIN
K060998 · Seradyn, Inc.
LCR · Fluorescent Immunoassay, Tobramycin · 101d
Cleared Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619 · Diazyme Laboratories
KHS · Enzymatic, Carbon-dioxide · 135d
Cleared Jul 21, 2006
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · Horiba Abx
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 176d
Cleared Jul 21, 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
K053597 · I-Stat Corporation
NBC · Test, Natriuretic Peptide · 210d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 20d
Cleared Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236 · Runbio Biotech Co.,Ltd
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 242d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 22d
Cleared Jul 13, 2006
PRODIGY BLOOD GLUCOSE TEST SYSTEM
K060467 · Diagnostic Devices, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 140d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 24d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc.
LDP · Colorimetry, Acetaminophen · 27d

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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