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S-Test C-Reactive Protein (Crp)

by Alfa Wassermann Diagnostic Technologies, Inc. 510(k)

Active United States

510(k) K083040

Overview

The S-TEST C-REACTIVE PROTEIN (CRP) is a system test for C-reactive protein, classified as a device in the immunology specialty. It is a single-use plastic cartridge containing two individual reagents in separate wells, a reaction well with a photometric cuvette, and a barcode label that provides chemistry parameters, calibration factors, and product information for the instrument.

The device is intended for the quantitative determination of C-reactive protein concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurement of C-reactive protein aids in the evaluation of the amount of injury to body tissues. It is supplied as a single-use device and has received FDA 510(k) clearance under k-number K083040, with product code DCN and regulation number 866.5270.

AI-generated from registry data, 25 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 NumberK083040 Date30 Jan 2009ClearedStatusActive

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
DCN
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 S-TEST C-Reactive Protein (CRP) used for?

    The S-TEST CRP is intended for the quantitative determination of C-reactive protein concentration in serum or heparin plasma. Measurement of CRP aids in evaluating the amount of injury to body tissues, supporting clinical assessment of inflammation or tissue damage when used with the S40 Clinical Analyzer.

  • How is the S-TEST CRP supplied and is it reusable?

    The device is supplied as a single-use plastic cartridge containing two individual reagents in separate wells, a reaction well with a photometric cuvette, and a barcode label. It is designed for one-time use only and should not be reused, as reuse could compromise accuracy and safety.

  • What information does the barcode on the S-TEST CRP cartridge provide?

    The barcode label on the cartridge provides chemistry parameters, calibration factors, and product information necessary for the S40 Clinical Analyzer to correctly interpret the test results. This ensures accurate quantification of CRP levels in patient samples.