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
11222 Chemistry devices
3476–3500 of 11222
Cleared Jun 18, 1999
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · Chiron Diagnostics Corp.
CDP · Radioimmunoassay, Total Triiodothyronine · 31d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · Kamiya Biomedical Co.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 115d
Cleared Jun 18, 1999
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
K990250 · Morax
LBT · Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl · 143d
Cleared Jun 16, 1999
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498 · Neometrics, Inc.
JIA · Enzymatic Methods, Galactose · 48d
Cleared Jun 11, 1999
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
K991447 · Spectral Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 46d
Cleared Jun 10, 1999
K-ASSAY MICROALBUMIN CALIBRATOR SET
K991166 · Kamiya Biomedical Co.
JIX · Calibrator, Multi-analyte Mixture · 64d
Cleared Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 14d
Cleared Jun 09, 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 14d
Cleared Jun 09, 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · Diagnostic Products Corp.
MMI · Immunoassay Method, Troponin Subunit · 14d
Cleared Jun 02, 1999
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · Biocheck, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 37d
Cleared Jun 02, 1999
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · Biocheck, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 47d
Cleared Jun 02, 1999
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
K990658 · Little Nell Labs, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 93d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 55d
Cleared May 28, 1999
INSURE PREGNANCY TEST
K991515 · Inbios Intl., Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 28d
Cleared May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
K991299 · Princeton BioMeditech Corp.
JHT · Chromatographic Separation, Cpk Isoenzymes · 52d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 60d
Cleared May 28, 1999
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
K991156 · Great Smokies Diagnostic Laboratory
JOC · Colorimetric, Xylose · 51d
Cleared May 28, 1999
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
K991088 · Becton Dickinson Vacutainer Systems
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 57d
Cleared May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · Polymer Technology Systems, Inc.
LBR · Ldl & Vldl Precipitation, Hdl · 122d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
K991466 · Selfcare, Inc.
CEP · Radioimmunoassay, Luteinizing Hormone · 28d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
K991386 · Selfcare, Inc.
CEP · Radioimmunoassay, Luteinizing Hormone · 34d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247 · A.P. Total Care, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 43d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · A.P. Total Care, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 43d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
K991111 · A.P. Total Care, Inc.
CIC · Cresolphthalein Complexone, Calcium · 54d
Cleared May 25, 1999
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · A.P. Total Care, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 54d

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All categories 11222 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 463 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 301 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 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