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.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
951–975 of 3201
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · Dade Behring, Inc.
JIS · Calibrator, Primary · 51d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · Roche Diagnostics Corp.
CEM · Electrode, Ion Specific, Potassium · 22d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · Dade Behring, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 18d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 48d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 57d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 61d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · Medline Industries, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 143d
Cleared Sep 12, 2001
LIQUICHEK TDM CONTROL
K012741 · Bio-Rad
DIF · Drug Mixture Control Materials · 27d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 57d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad
JJT · Enzyme Controls (assayed And Unassayed) · 24d
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 33d
Cleared Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
K012513 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 28d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · Diagnostic Products Corp.
LCD · Enzyme Immunoassay, Gentamicin · 28d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · Roche Diagnostics Corp.
MRR · System, Test, Low Density, Lipoprotein · 18d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co.
DKZ · Enzyme Immunoassay, Amphetamine · 16d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · Dade Behring, Inc.
DLJ · Calibrators, Drug Specific · 97d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871 · Dade Behring, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 108d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · Diagnostic Products Corp.
CEW · Radioimmunoassay, Parathyroid Hormone · 47d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 66d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp.
JFJ · Catalytic Methods, Amylase · 91d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38