CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT— 510(k) K101852
Substantially EquivalentIris International Inc., A Division of Iris Iris I
FDA 510(k) clearance K101852 for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT, Substantially Equivalent on 2011-03-23. Applicant: Iris International Inc., A Division of Iris Iris I. Device class: 1.
Clearance details
- Applicant
- Iris International Inc., A Division of Iris Iris I
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chatsworth, CA, US
Recent devices under product code KQO
view all- K141874 — URISCAN OPTIMA
- K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
- K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
- K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
- K102188 — CYBOW READER, MODELS 300 & 720
Recalls naming K101852
K-number listed on FDA's recall record- Z-1944-2020 — iChem¿VELOCITY Urine Chemistry System-
- Z-1535-2020 — iChemVELOCITY Strips, Catalog 800-7212
- Z-0843-2020 — iChem VELOCITY Urine Chemistry Analyzer
- Z-0913-2020 — iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
- Z-1937-2019 — iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
- Z-1894-2018 — iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
- Z-1643-2018 — BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
- Z-1893-2018 — iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
- Z-1384-2017 — iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
- Z-1067-2016 — iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
- Z-2441-2015 — iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101852.
Data sourced from openFDA. This site is unofficial and independent of the FDA.