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
11185 Chemistry devices
1176–1200 of 11185
Cleared Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · Radiometer Medical Aps
JJS · Controls For Blood-gases, (assayed And Unassayed) · 44d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 56d
Cleared Mar 14, 2013
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · Polymed Therapeutics, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 174d
Cleared Mar 12, 2013
PERKINELMER 226 SAMPLE COLLECTION DEVICES
K121864 · Perkinelmer, Inc.
PJC · Newborn Screening Specimen Collection Paper · 259d
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · Abaxis, Inc.
KHP · Acid, Lactic, Enzymatic Method · 54d
Cleared Mar 08, 2013
FASTPACK CONTROL KIT
K123725 · Qualigen, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 94d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · Philosys Co., Ltd.
CGA · Glucose Oxidase, Glucose · 455d
Cleared Mar 07, 2013
DIMENSION VISTA
K123677 · Siemens Healthcare Diagnostics
JIF · Enzymatic Method, Ammonia · 97d
Cleared Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
K123136 · Genesis Health Technologies
NBW · System, Test, Blood Glucose, Over The Counter · 153d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · Bio-Rad Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 37d
Cleared Mar 01, 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · Medica Corp.
CIG · Diazo Colorimetry, Bilirubin · 81d
Cleared Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · Roche Diagnostics
CIG · Diazo Colorimetry, Bilirubin · 64d
Cleared Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
K130200 · Abaxis, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 18d
Cleared Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
K123321 · Siemens Healthcare Diagnostics
JIX · Calibrator, Multi-analyte Mixture · 112d
Cleared Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · Siemens Healthcare Diagnostics
JIF · Enzymatic Method, Ammonia · 112d
Cleared Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
K122177 · Elitechgroup
JIT · Calibrator, Secondary · 207d
Cleared Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608 · Ortho-Clinical Diagnostics, Inc.
MRG · System, Test, Vitamin D · 259d
Cleared Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 62d
Cleared Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433 · Hmd Biomedical, Inc.
LFR · Glucose Dehydrogenase, Glucose · 276d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · Roche Diagnostics
NBW · System, Test, Blood Glucose, Over The Counter · 434d
Cleared Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
K123131 · Tosoh Bioscience, Inc.
MRG · System, Test, Vitamin D · 127d
Cleared Feb 07, 2013
TOXCUP DRUG SCREEN CUP
K122633 · Branan Medical Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 162d
Cleared Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · Cilag GmbH International
NBW · System, Test, Blood Glucose, Over The Counter · 336d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 349d
Cleared Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
K123050 · Nantong Biotechnology Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 130d

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All categories 11185 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 456 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 247 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