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N-Assay Tia Apo A1 Test Kit

by Crestat Diagnostics, Inc. 510(k)

Active United States

510(k) K964292

Overview

The N-Assay Tia Apo A1 Test Kit is an in vitro diagnostic reagent system designed for the quantitative measurement of apoprotein A-1 in human serum. It utilizes an immunoturbidimetric assay principle to measure the presence of apoprotein A-1 through observed turbidity changes.

This device is classified as an Alpha-1-Lipoprotein antigen, antiserum, and control system under regulation number 866.5580. It has received FDA 510(k) clearance as a Class 2 medical device under K964292.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964292 Date1 Aug 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DER
Device Class
Class II
Regulation
21 CFR Part 866.5580
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary function of the N-Assay TIA Apo A1 Test Kit?

    This test kit is an in vitro diagnostic reagent system designed specifically for the quantitative measurement of apoprotein A-1 levels in human serum. It provides clinicians with a standardized method to assess this specific protein.

  • What methodology does this test kit use to detect apoprotein A-1?

    The system utilizes an immunoturbidimetric assay principle. This method measures the presence of apoprotein A-1 by observing turbidity changes within the sample, which allows for the quantitative analysis of the target antigen.

  • What is the regulatory status of this device?

    The N-Assay TIA Apo A1 Test Kit is a Class 2 medical device that has received FDA 510(k) clearance under K964292. It is classified under regulation number 866.5580 as an Alpha-1-Lipoprotein antigen, antiserum, and control system.