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Protein C Control Plasma

by American Bioproducts Co.

510(k) K861216

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861216 Date16 May 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Qualitative and Quantitative Factor Deficiency Test Control Plasma, used as a reference standard for coagulation assays. It provides a calibrated plasma sample for monitoring and validating the performance of Protein C assays in hematology laboratories, ensuring accurate measurement of Protein C levels in patient samples.

The Protein C Control Plasma is supplied as a liquid for in vitro diagnostic use and is intended for single-use only. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K861216) as substantially equivalent to a predicate device. Sterility and stability are maintained under refrigerated conditions (2–8°C) until expiration, as specified on the labeling.

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Questions

AI-generated answers, 19 Sep 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 Protein C Control Plasma used for in a hematology lab, and how does it help ensure accurate testing?

    The Protein C Control Plasma serves as a calibrated reference standard for coagulation assays, specifically for monitoring and validating Protein C level measurements in patient samples. By providing a consistent plasma sample, it helps laboratories verify the performance and accuracy of their Protein C assays, ensuring reliable diagnostic results.

  • Is the Protein C Control Plasma intended for single-use or repeated use, and how should it be stored?

    The Protein C Control Plasma is designed for single-use only. To maintain sterility and stability, it must be stored under refrigerated conditions between 2–8°C until the expiration date printed on the labeling.

  • What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

    The Protein C Control Plasma received FDA 510(k) clearance (K861216) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulations.

  • How is this control plasma supplied, and what form does it take for laboratory use?

    The Protein C Control Plasma is supplied as a liquid for in vitro diagnostic use, providing a ready-to-use reference sample for coagulation testing in hematology laboratories.