Beta-2-Microglobulin

K161297 · Beckman Coulter Ireland, Inc. · JZG · Jun 7, 2016 · Immunology

Device Facts

• Record ID: K161297
• Device Name: Beta-2-Microglobulin
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JZG · Immunology
• Decision Date: Jun 7, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Indications for Use

The βeta-2-Microglobulin assay is an in vitro diagnostic test for the quantitative determination of βeta-2-microglobulin in human serum and urine. Measurement of βeta-2-microglobulin is used in the diagnosis and management of renal impairment and in the assessment of renal tubular function.

Device Story

In vitro diagnostic assay; measures βeta-2-microglobulin levels in human serum and urine; used by clinical laboratory personnel; provides quantitative results to clinicians for renal function assessment; modification involves updated on-board stability claims and calibration frequency; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only; verification and validation activities performed to assess impact of stability and calibration frequency changes; no clinical data required for this modification.

Technological Characteristics

Liquid, ready-to-use reagent kit. Principle: Immunoturbidimetric assay. Reagents: Phosphate buffer, latex particles coated with rabbit IgG anti-ß-2-Microglobulin antibodies, Polyethylene Glycol, preservatives. Form factor: 4x10mL R1 and 4x8mL R2 vials. Compatible with Beckman Coulter AU series analyzers. Calibration: Serum Protein Multi-calibrator 2.

Indications for Use

Indicated for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum to aid in the assessment of patients with renal diseases or active rheumatoid arthritis.

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.

Predicate Devices

• ß-2-Microglobulin (K991136)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K161297

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II 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. Olympus America, Inc.βeta-2-Microglobulin (K991136). Beckman Coulter has since acquired Olympus America Inc. and is the current 510(k) holder.

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 labeling was updated with the current stability changes for on-board stability and calibration frequency. The changes 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. Change in stability claim for on-board stability and calibration frequency.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance studies of the βeta-2-Microglobulin.

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.