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Asserachrom HPIA Test Kit

by Diagnostica Stago, Inc.

510(k) K003767

Active European Union and United States

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K003767↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK003767 Date12 Feb 2001ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1084-2026 FDA Class II initiated 15 Dec 2025

    Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
LCO
Device class
Class II
Regulation
21 CFR Part 864.7695
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 Asserachrom HPIA Test Kit is a Platelet Factor 4 Radioimmunoassay, classified under the nomenclature for hematology diagnostics. It is designed for the qualitative detection of antibodies against platelet factor 4 in human plasma, aiding in the diagnosis of heparin-induced thrombocytopenia (HIT).

This test kit is supplied as a single-use diagnostic reagent intended for in vitro laboratory use. It requires no special storage conditions beyond refrigeration at 2–8°C and is regulated under FDA 510(k) clearance (K003767) and the In Vitro Diagnostic Device Directive (IVDD). The kit is classified as a Class II medical device and is intended for professional use in accredited hematology laboratories.

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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 condition is the Asserachrom HPIA Test Kit primarily used to diagnose or monitor?

    The Asserachrom HPIA Test Kit is designed for the qualitative detection of antibodies against platelet factor 4 (PF4) in human plasma, which aids in diagnosing heparin-induced thrombocytopenia (HIT). HIT is a serious condition where the body’s immune system mistakenly attacks platelets after exposure to heparin, a blood-thinning medication.

  • Is the Asserachrom HPIA Test Kit intended for single-use or can it be reused?

    The kit is explicitly labeled as a single-use diagnostic reagent, meaning each test kit is intended for one use only. This ensures accuracy and prevents cross-contamination, which is critical for reliable in vitro diagnostic testing.

  • What storage conditions are required for the Asserachrom HPIA Test Kit?

    The kit does not require special storage conditions beyond standard refrigeration. It should be stored at temperatures between 2–8°C to maintain its integrity and performance for laboratory use.

  • How is the regulatory status of the Asserachrom HPIA Test Kit defined?

    The device holds both FDA 510(k) clearance (under reference number K003767) and compliance with the In Vitro Diagnostic Device Directive (IVDD). It is classified as a Class II medical device, indicating it has undergone rigorous review for safety and effectiveness in professional hematology laboratory settings.