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STA- NeoPTimal

by Diagnostica Stago S.A.S

510(k) K211485

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211485↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK211485 Date23 Dec 2022ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GJS
Device Class
Class II
Regulation
21 CFR Part 864.7750
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.

The STA-NeoPTimal is a coagulation screening test classified as a prothrombin time (PT) assay. It is designed to evaluate the extrinsic coagulation pathway and monitor oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

This device is intended for use in professional laboratory settings and is supplied as a reagent for automated coagulation analyzers. Authorized under FDA 510K and IVDR compliance, it is intended for single-use applications. The product is regulated under the medical specialty of hematology and falls under device class II (GJS).

Other devices from Diagnostica Stago S.A.S

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 clinical pathway does the STA-NeoPTimal support, and why is it specifically designed for professional lab use?

    The STA-NeoPTimal supports evaluation of the extrinsic coagulation pathway and monitoring of oral vitamin K antagonist therapy through the International Normalized Ratio (INR). It is designed for professional laboratory settings because it is a reagent intended for use exclusively with automated coagulation analyzers, ensuring precise and standardized results critical for clinical decision-making in hematology.

  • Is the STA-NeoPTimal intended for reuse, or is it meant to be used only once per test? How does this affect its handling?

    The STA-NeoPTimal is explicitly intended for single-use applications. This design ensures patient safety and accuracy, as reuse could compromise sterility and reliability. Users must adhere to single-use protocols to maintain consistency and avoid cross-contamination between tests.

  • What regulatory pathways does the STA-NeoPTimal follow, and how does this impact its availability or use?

    The STA-NeoPTimal is authorized under both the FDA’s 510K pathway (traditional clearance, classified as substantially equivalent) and the EU’s In Vitro Diagnostic Regulation (IVDR). This dual authorization ensures compliance with both U.S. and European standards, allowing its use in regulated laboratories across these markets while adhering to strict quality and safety requirements.

  • How is the STA-NeoPTimal supplied, and what type of equipment is required to use it?

    The STA-NeoPTimal is supplied as a reagent designed specifically for automated coagulation analyzers. It is not a standalone device but rather a consumable component that integrates with these systems to perform prothrombin time (PT) assays. Laboratories must use compatible analyzers to ensure proper functionality and accurate results.

  • What medical specialty does the STA-NeoPTimal fall under, and why is this relevant for clinicians?

    The STA-NeoPTimal is classified under the medical specialty of hematology, as indicated by its regulatory filing. This classification is relevant for clinicians because it confirms the device’s primary use in monitoring blood coagulation disorders and managing anticoagulant therapy, aligning with the expertise of hematologists and related specialists.