iChemVELOCITY Automated Urine Chemistry System
Device Facts
| Record ID | K171083 |
|---|---|
| Device Name | iChemVELOCITY Automated Urine Chemistry System |
| Applicant | Iris Diagnostics, A Division of Iris International, Inc. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | May 12, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Indications for Use
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 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, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChem Velocity 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. 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 iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Device Story
Automated urine chemistry analyzer; processes urine samples via test strips and optical modules. Inputs: urine samples in test tubes; light reflectance from test strips; light transmittance/scattering through urine for color/clarity; refractive index for specific gravity. Operation: Strip Reader Module (SRM) measures reflectance; Color/Clarity Module (CCM) measures light transmission/scattering via color sensor; Specific Gravity Module (SGM) measures refractive index. Output: quantitative specific gravity; semi-quantitative chemistry results; qualitative color/clarity. Used in clinical laboratories; operated by lab personnel. Output displayed to clinicians to aid diagnosis of metabolic, renal, urinary, and liver conditions. Design change involves replacing end-of-life color sensor (TCS230 to TCS3200) and scatter LED, with updated firmware algorithm for color detection.
Clinical Evidence
Bench testing only. Method comparison and precision studies performed. Method comparison evaluated color/clarity results against the predicate; precision studies (n=240 per level) demonstrated high exact agreement (95-100%) and 100% agreement within ±1 block for all color and clarity categories.
Technological Characteristics
Automated urine chemistry analyzer. CCM utilizes Taos TCS3200 color sensor and Luxeonstar/Lumileds SR-01-WC100 scatter LED. Specific gravity measured via refractive index. SRM measures light reflectance. Microcontroller (PIC 18F25) uses UART communication. Firmware implements color detection using HSL color space and Ohta Color plane. Powered by internal switching mode power supply (AC to DC).
Indications for Use
Indicated for clinical laboratory use to automate urine chemistry analysis in patients requiring diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care (POC) use.
Regulatory Classification
Identification
A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
Related Devices
- K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT · Iris International Inc., A Division of Iris Iris I · Mar 23, 2011
- K980047 — URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER · Yeongdong Pharmaceutical Corp. · Jun 10, 1998
