HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

K122066 · The Binding Site Group , Ltd. · JZG · Aug 30, 2012 · Immunology

Device Facts

• Record ID: K122066
• Device Name: HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: JZG · Immunology
• Decision Date: Aug 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Indications for Use

The kit is intended for the quantitative in vitro determination of beta-2 microglobulin (β2M) in human unne using the SPAPLUS analyser, to aid the diagnosis of active rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings

Device Story

The Human Beta-2 Microglobulin Kit is an in vitro diagnostic assay designed for use on the SPAplus analyzer. It measures β2M levels in human urine samples. The device utilizes an immunological test system to quantify β2M, providing data to assist clinicians in diagnosing active rheumatoid arthritis and kidney disease. It is intended for professional use in clinical laboratory settings. Results are interpreted by healthcare providers alongside other clinical and laboratory findings to inform diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics of the immunological test system.

Technological Characteristics

In vitro diagnostic assay for Beta-2 Microglobulin; utilizes SPAplus™ analyzer platform. Fundamental scientific technology unchanged from predicate (K083289).

Indications for Use

Indicated for quantitative in vitro determination of beta-2 microglobulin (β2M) in human urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease. For prescription use only.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER

k122066

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 (delete/add items as necessary):

1. 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.)

Human Beta-2 Microglobulin Kit for use on SPAplus™, K083289.

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

The predicate was previously cleared test for serum and urine. The modified device includes a labeling change to market the urine test separately. This labeling change does 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 change in the marketing of the test for a single matrix – urine – specified in the labeling.

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

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
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) 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.