URISCAN OPTIMA II URINE ANALYZER

K050801 · Yd Diagnostics · JIL · Apr 20, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050801
• Device Name: URISCAN OPTIMA II URINE ANALYZER
• Applicant: Yd Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: Apr 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

The UriScan Optima II Urine Analyzer is an automated system for use with UriScan for routine urinalysis through the analysis of blood, bilirubin, urobilinggen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.

Device Story

Uriscan Optima II Urine Analyzer; automated system for urine analysis. Modification adds capability for urine color determination. Device processes urine samples; utilizes optical sensing technology to measure color and other parameters. Operated by clinical laboratory personnel. Output provided to healthcare providers for diagnostic assessment of patient urine samples. Modification verified via design control activities, risk analysis, and validation protocols to ensure fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated urine analyzer; utilizes colorimetric reflectance photometry to measure urine test strips. System is designed for professional clinical use. Connectivity and specific software architecture details are not provided in the source document.

Indications for Use

Indicated for use as a urine analyzer for the determination of urine color and other parameters in clinical settings.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k050801

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the URISCAN OPTIMA II URINE ANALYZER:

1. The name and 510(k) number of YD DIAGNOSTICS's previously cleared device, URISCAN OPTIMA II URINE ANALYZER, cleared under k980047. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/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.

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 the determination of urine color.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

4. 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

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk which is a FTA

revised:3/27/98