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
11199 Chemistry devices
1901–1925 of 11199
Cleared Dec 21, 2007
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
K072784 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 81d
Cleared Dec 21, 2007
IRISPEC,CA/CB/CC
K072640 · Iris Diagnostics
JJW · Urinalysis Controls (assayed And Unassayed) · 94d
Cleared Dec 20, 2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
K072599 · Diadexus, Inc.
NOE · Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 · 97d
Cleared Dec 20, 2007
ENVOY 500 HDL
K071706 · Clinical Data, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 182d
Cleared Dec 18, 2007
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
K071930 · Blue Cross Bio-Medical Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 158d
Cleared Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · bioMerieux, Inc.
MMI · Immunoassay Method, Troponin Subunit · 414d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 78d
Cleared Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
K072835 · Bio-Rad, Diagnostics Grp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 69d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · Bio-Rad, Diagnostics Grp.
DIF · Drug Mixture Control Materials · 76d
Cleared Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
K073157 · Ortho-Clinical Diagnostics, Inc.
CEM · Electrode, Ion Specific, Potassium · 29d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · Biosite Incorporated
JJY · Multi-analyte Controls, All Kinds (assayed) · 58d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · Bayer Healthcare, LLC
JFM · Enzymatic Method, Bilirubin · 345d
Cleared Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
K072264 · Qualigen, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 113d
Cleared Dec 04, 2007
MICROPROTEIN REAGENT SET
K070757 · Pointe Scientific, Inc.,
JGP · Lowry (colorimetric), Total Protein · 259d
Cleared Dec 03, 2007
CREATININE (ENZYMATIC)
K070824 · Thermofisher Scientific OY
JFY · Enzymatic Method, Creatinine · 252d
Cleared Dec 03, 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 333d
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
K072783 · Smiths Medical Asd, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 60d
Cleared Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
K072115 · Horiba Abx
CGX · Alkaline Picrate, Colorimetry, Creatinine · 121d
Cleared Nov 26, 2007
PRIMUS A1CARE ASSAY
K062658 · Primus Corp.
LCP · Assay, Glycosylated Hemoglobin · 446d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc.
CDD · Radioassay, Vitamin B12 · 195d
Cleared Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
K063852 · Home Access Health Corp.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 316d
Cleared Nov 06, 2007
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · Gentian AS
NDY · Test, Cystatin C · 172d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · Abbott Diabetes Care, Inc.
LFR · Glucose Dehydrogenase, Glucose · 209d
Cleared Oct 26, 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
K071493 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 149d
Cleared Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
K070484 · Quantrx Biomedical Corporation
NGA · Test, Follicle Stimulating Hormone (fsh), Over The Counter · 244d

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All categories 11199 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 458 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