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
11183 Chemistry devices
1051–1075 of 11183
Not Cleared Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
DEN130011 · Illumina, Inc.
PFF · High Throughput Dna Sequence Analyzer · 57d
Cleared Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
K131284 · Wallac OY
NAK · System, Test, Biotinidase · 192d
Cleared Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · Co-Innovation Biotech Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 130d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · DiaSorin, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 88d
Cleared Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
K131236 · Ucp Biosciences, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 190d
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · Unistrip Technologies, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 744d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · Prodigy Diabetes Care, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 460d
Cleared Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · Hitachi Chemical Diagnostics, Inc.
CDN · Urease, Photometric, Urea Nitrogen · 82d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 25d
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
K132227 · Bio-Rad Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 100d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · Bionime Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · Delbio Incorporation
NBW · System, Test, Blood Glucose, Over The Counter · 90d
Cleared Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 104d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 22d
Cleared Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
K132751 · Techno-Path Manufacturing , Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 49d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics
JHY · Colorimetric Method, Cpk Or Isoenzymes · 64d
Cleared Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
K130213 · Lumiquick Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 262d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · Glooko, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 87d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 189d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc.
CJW · Bromcresol Purple Dye-binding, Albumin · 50d
Cleared Oct 15, 2013
MULTICHEM U
K131993 · Techno-Path Manufacturing , Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 109d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc.
LFR · Glucose Dehydrogenase, Glucose · 151d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 125d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546 · Beckman Coulter Ireland, Inc.
KHS · Enzymatic, Carbon-dioxide · 133d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · Mitsubishi Chemical Medience Corporation
JIT · Calibrator, Secondary · 210d

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All categories 11183 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 455 JJX Single (specified) Analyte Controls (assayed And Unassayed) 382 CGA Glucose Oxidase, Glucose 298 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 246 CIG Diazo Colorimetry, Bilirubin 216 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 156 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143