AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

K093098 · Arkray, Inc. · KQO · Dec 23, 2009 · Clinical Chemistry

Device Facts

• Record ID: K093098
• Device Name: AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
• Applicant: Arkray, Inc.
• Product Code: KQO · Clinical Chemistry
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Indications for Use

The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

Device Story

Automated urine analyzer; processes urine samples using AUTION Sticks 9EB multi-parameter test strips. Device features loading/unloading sides for samples, LCD display, operator panel, and built-in printer. Operates on 100-240VAC. Used in clinical settings by healthcare professionals to measure analytes including glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. Provides automated analysis to assist clinicians in diagnostic decision-making regarding patient health status.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to confirm modifications met predetermined acceptance criteria.

Technological Characteristics

Automated urine analyzer; 100-240VAC power; LCD display; built-in printer. Complies with UL 61010-1, IEC 61010-1/2-101/2-081, EN 61326, and FCC Part 15. Uses AUTION Sticks 9EB multi-parameter test strips.

Indications for Use

Indicated for in vitro measurement of urine analytes (glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, color) in clinical settings using AUTION Sticks 9EB test strips.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• AUTION MAX AX-4280 Urinalysis System (K013783)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k093098

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable;

The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) ARKRAY AUTION MAX AX-4280, k013783.

1. 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 (labeling changes are permitted as long as they do not affect the intended use).

2. 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 altering the dimensions of the analyzer and the display screen. The specific gravity, color tone, and turbidity measurement methods were also modified.

3. 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.

5. 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.