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
1901–1925 of 13257
Cleared Oct 31, 2008
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
K080057 · Novx Systems, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 296d
Cleared Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
K081543 · Ortho-Clinical Diagnostics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 143d
Cleared Oct 22, 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
K082513 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 50d
Cleared Oct 21, 2008
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
K082417 · Arkray Factory USA, Inc.
CGA · Glucose Oxidase, Glucose · 60d
Cleared Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 198d
Cleared Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · Horiba Abx
LCP · Assay, Glycosylated Hemoglobin · 329d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · Siemens Healthcare Diagnostics
JIT · Calibrator, Secondary · 25d
Cleared Oct 10, 2008
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
K080851 · Anticancer, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 198d
Cleared Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · Bayer Healthcare, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 41d
Cleared Oct 07, 2008
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
K082618 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 28d
Cleared Oct 06, 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 132d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
K082645 · Siemens Healthcare Diagnostics
NBC · Test, Natriuretic Peptide · 11d
Cleared Sep 18, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
K082395 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 30d
Cleared Sep 18, 2008
S40 CREATINE KINASE (CK)
K082226 · Alfa Wassermann Diagnostic Technologies, Inc.
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 42d
Cleared Sep 18, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
K081451 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 118d
Cleared Sep 17, 2008
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121 · Eps Bio Technology Corp.
CGA · Glucose Oxidase, Glucose · 51d
Cleared Sep 17, 2008
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 54d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · Tosoh Bioscience, Inc.
LCP · Assay, Glycosylated Hemoglobin · 512d
Cleared Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · Horiba Abx
CFR · Hexokinase, Glucose · 130d
Cleared Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
K081450 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 111d
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · Siemens Healthcare Diagnostics, Inc.
JIT · Calibrator, Secondary · 77d
Cleared Sep 05, 2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
K080960 · Abbott Diabetes Care, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 155d
Cleared Sep 05, 2008
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
K080435 · Olympus Life Science Research Europa GmbH (Europa)
CIG · Diazo Colorimetry, Bilirubin · 199d
Cleared Sep 03, 2008
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
K082141 · Biokit, S.A.
JIT · Calibrator, Secondary · 35d
Cleared Sep 03, 2008
OLYMPUS TOTAL BHCG TEST SYSTEN
K080094 · Olympus Life Science Research Europa GmbH (Europa)
DHA · System, Test, Human Chorionic Gonadotropin · 233d

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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