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Tina-quant Alpha PARTICLE-1-ANTITRYPSIN Assay

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K972640

Overview

The Tina-quant Alpha Particle-1-antitrypsin Assay is an in vitro diagnostic device used for the quantitative determination of alpha-1-antitrypsin antigen levels in human serum. It is classified as a Class II medical device under regulation number 866.5130 and falls within the immunology medical specialty.

The assay is intended for professional use in clinical laboratory settings. Healthcare providers use the resulting quantitative values to assist in diagnosing liver cirrhosis and pulmonary emphysema associated with alpha-1-antitrypsin deficiency. It received FDA 510(k) clearance (K972640) as substantially equivalent to a predicate device, with a traditional review pathway and decision date of January 9, 1998.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972640 Date9 Jan 1998ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DEM
Device Class
Class II
Regulation
21 CFR Part 866.5130
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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