Immunoglobulins G, A & M Light Chain Specific

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K924767 ↗

FDA Product Code

CFF

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from The Binding Site, Ltd. →

• What is the IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC device used for?

  This device is an immunoelectrophoretic test designed for the quantitative analysis of serum immunoglobulins G, A, and M light chains. It serves as a first-line diagnostic measure to assess immunoglobulin levels in clinical settings, aiding in the evaluation of immune system function and related disorders.

• How is the IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC test supplied and by whom?

  The device is supplied by The Binding Site, Ltd., as indicated in the manufacturer and applicant fields. It is provided as a test kit for immunoelectrophoretic analysis, though specific kit components or packaging details are not included in the provided data beyond the manufacturer's role in distribution and authorization.

• Is the IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC device sterile or single-use?

  The provided device data does not specify whether the test is sterile, single-use, or reusable. Information regarding sterility, use limitations, or disposal instructions is not included in the specifications or authorization details, so no conclusion can be drawn about its reuse status from the available facts.

• What regulatory pathway was used for the IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC device?

  The device received FDA 510(k) clearance under submission number K924767, as stated in the AUTHORIZATIONS and openfda fields. It was cleared via a traditional 510(k) pathway, with a decision date of February 23, 1993, and classified as substantially equivalent to a predicate device.

• What is the classification and product code for the IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC test?

  The device is classified as a Class II medical device with product code CFF, as shown in the specifications and openfda fields. It falls under regulation number 866.5510 and is part of the immunology medical specialty, with the advisory committee designated as IM (Immunology).