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V-Trend Target CRP Test

by Texas Immunology, Inc. 510(k)

Active United States

510(k) K890423

Overview

The V-Trend Target CRP Test is a qualitative in vitro diagnostic device used for the detection of C-Reactive Protein (CRP) antigen in human serum or plasma. CRP is a marker commonly employed to assess inflammation, infection, or tissue injury, aiding in diagnostic evaluations within immunology.

This device is supplied as a single-use diagnostic kit and is intended for use in clinical laboratory settings. It requires no special storage conditions beyond standard laboratory practices and is regulated under FDA 510(k) clearance (K890423) with a classification of Class II (DCK). The test follows standard immunology procedures and is not intended for MRI or other imaging environments.

AI-generated from registry data, 19 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 NumberK890423 Date17 Feb 1989ClearedStatusActive

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 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 clinical setting is the V-Trend Target CRP Test designed for, and how is it used?

    The V-Trend Target CRP Test is designed exclusively for use in clinical laboratory settings. It is a qualitative in vitro diagnostic device intended to detect C-Reactive Protein (CRP) antigen in human serum or plasma. CRP is a biomarker used to assess inflammation, infection, or tissue injury, helping clinicians evaluate patients within immunology-related diagnostic workflows.

  • Is the V-Trend Target CRP Test single-use, and if so, what does this mean for workflow efficiency?

    Yes, the V-Trend Target CRP Test is supplied as a single-use diagnostic kit. This means each kit is intended for one test procedure, ensuring accuracy and preventing cross-contamination. Clinicians should order kits in advance based on expected patient volume to maintain workflow efficiency without waste.

  • What storage requirements does the V-Trend Target CRP Test have, and how should it be handled?

    The V-Trend Target CRP Test requires no special storage conditions beyond standard laboratory practices. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling ensures test integrity and reliability for detecting CRP levels in patient samples.

  • How is the regulatory status of the V-Trend Target CRP Test determined, and what does this mean for users?

    The V-Trend Target CRP Test holds FDA 510(k) clearance under the classification of Class II (DCK), with a decision code of SESE (Substantially Equivalent). This means it has been reviewed by the FDA’s Immunology (IM) advisory committee and deemed equivalent to a predicate device, ensuring it meets established safety and performance standards for CRP detection in clinical laboratories.