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
11229 Chemistry devices
4001–4025 of 11229
Cleared Oct 31, 1997
QUICK CARD HCG ONE STEP PREGNANCY TEST
K973570 · Phamatech
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 42d
Cleared Oct 31, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc.
CHP · Radioimmunoassay, Estradiol · 30d
Cleared Oct 31, 1997
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966 · Beckman Instruments, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 14d
Cleared Oct 29, 1997
MATRIX PLUS MULTI-CALIBRATOR KIT
K973345 · Verichem Laboratories, Inc.
JIX · Calibrator, Multi-analyte Mixture · 54d
Cleared Oct 29, 1997
IMMUSURE
K973894 · Quantimetrix Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 15d
Cleared Oct 27, 1997
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015 · Morax
LBT · Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl · 150d
Cleared Oct 27, 1997
SPIFE
K972274 · Helena Laboratories
CEF · Electrophoretic, Protein Fractionation · 131d
Cleared Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · Armkel, LLC
CEP · Radioimmunoassay, Luteinizing Hormone · 54d
Cleared Oct 27, 1997
BRAND NAME *1-STEP PREGNANCY
K973352 · Armkel, LLC
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 52d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · Pointe Scientific, Inc.,
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 30d
Cleared Oct 20, 1997
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · Ameritek, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 60d
Cleared Oct 20, 1997
FIRST SIGN
K973208 · Texas Immunology, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 54d
Cleared Oct 20, 1997
I-STAT SYSTEM
K973292 · I-Stat Corp.
CGL · Electrode, Ion Based, Enzymatic, Creatinine · 48d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · Schiapparelli Biosystems, Inc.
KLT · Enzyme Immunoassay, Carbamazepine · 32d
Cleared Oct 20, 1997
TROPONIN (TROP) METHOD
K973650 · Dade Chemistry Systems, Inc.
MMI · Immunoassay Method, Troponin Subunit · 25d
Cleared Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · Dade Intl., Inc.
JIT · Calibrator, Secondary · 25d
Cleared Oct 14, 1997
ABC LINEARITY VERIFIERS
K973790 · Sc Calibrators & Controls, LLC
JJY · Multi-analyte Controls, All Kinds (assayed) · 8d
Cleared Oct 14, 1997
ABC CALIBRATION VERIFIERS
K973791 · Sc Calibrators & Controls, LLC
JJY · Multi-analyte Controls, All Kinds (assayed) · 8d
Cleared Oct 10, 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · Pointe Scientific, Inc.,
JQB · Kinetic Method, Gamma-glutamyl Transpeptidase · 49d
Cleared Oct 09, 1997
GLUCOTREND BASIC SYSTEM
K972876 · Boehringer Mannheim Corp.
LFR · Glucose Dehydrogenase, Glucose · 66d
Cleared Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177 · Diamedix Corp.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 45d
Cleared Oct 08, 1997
LIQUID LDH-L REAGENT SET
K973589 · Pointe Scientific, Inc.,
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 16d
Cleared Oct 06, 1997
ACCUWELL T4-EIA
K972974 · Neometrics, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 56d
Cleared Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
K973126 · Biosite Incorporated
JHX · Fluorometric Method, Cpk Or Isoenzymes · 47d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358 · Boehringer Mannheim Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d

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All categories 11229 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 466 JJX Single (specified) Analyte Controls (assayed And Unassayed) 385 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