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Pool Norm

by Diagnostics Stago S.A.S. EUDAMED510(k)

Active European Union and United States

510(k) K142132

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142132 Date12 Dec 2014ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 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, 18 Sep 2026

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

Pool Norm is a lyophilized, citrated normal human plasma pool classified as a Plasma, Coagulation Control device. It serves as a quality control reagent for coagulation assays, specifically APTT and dRVVT tests, ensuring accurate and reliable assay performance in clinical settings.

This device is processed in clinical laboratories by certified personnel using automated analyzers such as the STA-R, STA Compact, and STA Satellite. Supplied as a single-use reagent, Pool Norm is regulated under FDA 510(k) clearance (K142132) and the In Vitro Diagnostic Device Directive (IVDD), adhering to classification GGN under regulation 864.5425. It is intended for use in hematology applications and requires proper storage as specified by the manufacturer.

Questions

AI-generated answers, 18 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 Pool Norm used for in a clinical laboratory setting?

    Pool Norm is a lyophilized, citrated normal human plasma pool designed specifically as a quality control reagent for coagulation assays. It ensures the accuracy and reliability of APTT (Activated Partial Thromboplastin Time) and dRVVT (diluted Russell’s Viper Venom Time) tests, which are critical for monitoring coagulation disorders and assessing treatment efficacy in patients.

  • Is Pool Norm intended for single-use or can it be reused?

    Pool Norm is explicitly supplied as a single-use reagent. This design ensures consistency and reliability in coagulation testing, as reuse could compromise sterility and accuracy of the quality control results.

  • Which automated analyzers is Pool Norm compatible with?

    Pool Norm is processed in clinical laboratories using certified personnel and is compatible with STA-R, STA Compact, and STA Satellite analyzers. These systems are designed for coagulation assays, ensuring seamless integration with the reagent.

  • How should Pool Norm be stored, and what are the implications of improper storage?

    While the exact storage instructions are manufacturer-specified, lyophilized reagents like Pool Norm generally require dry conditions and protection from light to maintain stability. Improper storage could degrade the plasma components, leading to inaccurate coagulation test results and compromising the reagent’s effectiveness as a quality control measure.

  • What regulatory pathways does Pool Norm follow, and how does this affect its use?

    Pool Norm is regulated under both the FDA’s 510(k) clearance (K142132) and the In Vitro Diagnostic Device Directive (IVDD), adhering to classification GGN under regulation 864.5425. This means it has undergone rigorous evaluation to ensure safety and performance, allowing clinical laboratories to rely on it for quality control in coagulation testing with confidence in its compliance standards.