iQ200 System, iChemVELOCITY Automated Urine Chemistry System

K210127 · Beckman Coulter, Inc. · LKM · Jul 2, 2021 · Hematology

Device Facts

Record IDK210127
Device NameiQ200 System, iChemVELOCITY Automated Urine Chemistry System
ApplicantBeckman Coulter, Inc.
Product CodeLKM · Hematology
Decision DateJul 2, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 864.5200
Device ClassClass 2

Indications for Use

iQ200 System: The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. iChemVELOCITY Automated Urine Chemistry System: 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 Chemietry 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 esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid: and qualitative results for nitrite, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they 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 iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.

Device Story

iQ200/iChemVELOCITY systems automate urinalysis in clinical laboratories. iQ200 uses CCD camera imaging of urine samples in flow cells; Auto-Particle Recognition (APR) software classifies particles (cells, casts, crystals, organisms) by size, shape, contrast, and texture. iChemVELOCITY uses reflectance photometry on test strips, refractometry for specific gravity, and optical absorbance/scattering for color/clarity. Systems operate via workstation software (APUI v7.2) on Windows 7/XP. Updated software adds duplicate specimen ID flagging (based on user-defined 12-72 hour windows) and cybersecurity patches for Windows XP (Bluekeep/WannaCry). Technologists review flagged results via workstation interface; system allows manual override of automated classifications. Benefits include standardized, high-throughput urinalysis and reduced manual microscopy burden.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design verification, software verification, system performance verification, and human factors testing related to the software modification.

Technological Characteristics

Automated urinalysis system; iQ200 uses CCD camera imaging/flow cell microscopy; iChemVELOCITY uses reflectance photometry, refractometry, and optical absorbance/scattering. Components include Taos TCS230 color sensor, Luxeonstar/Lumileds SR-01-WC100 LED, PIC 18F25 microcontroller. Software: APUI v7.2 (Windows 7/XP). Cybersecurity: Patched for Bluekeep/WannaCry vulnerabilities; isolated network architecture; user access controls.

Indications for Use

Indicated for clinical laboratory use to automate urinalysis profiles, including urine chemistry and microscopic sediment analysis, to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care (POC) use.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K210127 B Applicant Beckman Coulter, Inc. C Proprietary and Established Names iQ200 System iChemVELOCITY Automated Urine Chemistry System D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | LKM | Class II | 21 CFR 864.5200 - Automated Cell Counter | HE - Hematology | | KQO | Class I | 21 CFR 862.2900 - Automated urinalysis system | CH - Clinical Chemistry | | GKL | Class II | 21 CFR 864.5200 - Automated cell counter | HE - Hematology | | JIL | Class II | 21 CFR 862.1340 - Urinary glucose (nonquantitative) test system | CH - Clinical Chemistry | ## II Review Summary: This Changes Being Effected (CBE) 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K101852 and K022774). Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for a modification to the iQ200 System and the iChemVELOCITY Automated Urine Chemistry System software to be implemented as part of the corrective action for a field action initiated by BEC in Z-0913-2020 and Z-0914-2020, respectively as reported on April 15, 2020. The workstation software, known as Analysis Processor User Interface (APUI), was modified to flag duplicate specimens. 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. K210127 - Page 2 of 2
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