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TIA CRP Test Kit

by Crestat Diagnostics, Inc. 510(k)

Active United States

510(k) K914155

Overview

The TIA CRP Test Kit is a diagnostic device used for the qualitative detection of C-Reactive Protein (CRP) in human serum. CRP is a blood protein that rises in response to inflammation, infection, or tissue injury, making this test useful in immunology for monitoring inflammatory conditions. The kit employs a turbidimmunometric assay to measure CRP levels, providing a reliable indicator for diagnostic evaluation.

This test kit is intended for in vitro diagnostic use and is supplied as a single-use, non-sterile reagent kit. It is classified under 21 CFR 866.5270 and has received FDA 510(k) clearance (K914155) as substantially equivalent to a predicate device. The kit includes antigen, antiserum, and control components, with product code DCK. Storage conditions and specific procedural instructions are detailed in the accompanying documentation.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914155 Date15 Jan 1992ClearedStatusActive

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
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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the TIA CRP Test Kit used for?

    The TIA CRP Test Kit is designed for the qualitative detection of C-Reactive Protein (CRP) in human serum. CRP is a blood protein that increases in response to inflammation, infection, or tissue injury, making this test valuable for diagnosing and monitoring inflammatory conditions in immunology.

  • How is the TIA CRP Test Kit supplied?

    The kit is supplied as a single-use, non-sterile reagent kit. It includes essential components such as antigen, antiserum, and control materials required for the turbidimmunometric assay. Detailed procedural instructions and storage guidelines are provided in the accompanying documentation.

  • Is the TIA CRP Test Kit sterile?

    No, the TIA CRP Test Kit is explicitly labeled as non-sterile. This classification is important for users to understand handling and preparation requirements before use, as it may influence workflows in clinical or laboratory settings.

  • What regulatory approval does the TIA CRP Test Kit hold?

    The TIA CRP Test Kit has received FDA 510(k) clearance under the classification 21 CFR 866.5270, with the clearance number K914155. This approval confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for in vitro diagnostic use.

  • What are the key components included in the TIA CRP Test Kit?

    The kit contains antigen, antiserum, and control components necessary for performing the turbidimmunometric assay. These components work together to detect CRP levels in human serum, enabling accurate diagnostic evaluation of inflammatory markers.