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Triage Protein C Controls and Calibration Verification Controls

by Biosite Incorporated

510(k) K062840

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062840 Date1 Mar 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GGN
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Triage Protein C Controls and Calibration Verification Controls are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. They are used in laboratory settings by professional staff to monitor test performance and validate the measurable range of the Triage Protein C Test.

These controls are stored frozen at < -20°C and are intended for use as external quality control materials in coagulation testing. The device has received FDA 510(k) clearance under K062840 and is classified as a Plasma, Coagulation Control under regulation number 864.5425.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Triage Protein C Controls and Calibration Verification Controls?

    These controls are used in laboratory settings by professional staff to monitor test performance and validate the measurable range of the Triage Protein C Test, serving as external quality control materials in coagulation testing.

  • How are Triage Protein C Controls and Calibration Verification Controls supplied and stored?

    They are supplied as single-use, 0.25 mL unit dose liquid preparations and must be stored frozen at < -20°C to maintain stability and performance as external quality control materials.

  • Are Triage Protein C Controls and Calibration Verification Controls reusable or single-use?

    They are designated as single-use devices, meaning each 0.25 mL unit dose is intended for one-time use only to prevent cross-contamination and ensure reliable quality control results.