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Hemosil Low Abnormal Control (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)

by Instrumentation Laboratory CO

510(k) K021022

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 ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021022↗

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 NumberK021022 Date14 May 2002ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0514-2014 FDA Class II initiated 15 Nov 2013
    • Terminated Z-0516-2014 FDA Class II initiated 15 Nov 2013
    • Terminated Z-0515-2014 FDA Class II initiated 15 Nov 2013

    HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

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  • Withdrawn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)

Full name
Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)
510(k) Number
FDA Product Code
GGN
Models / Variants
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.

This device is a Plasma, Coagulation Control, designed for quality assurance in coagulation assays within the low abnormal range. It consists of two variants: an assayed control with predefined values and an unassayed control for manual verification, both simulating abnormal coagulation parameters in citrated human plasma from healthy donors.

The controls are supplied as liquid plasma and intended for use on coagulation analyzers, including IL Coagulation and ELECTRA™ Systems. They are single-use, non-sterile, and require no special storage conditions beyond refrigeration. Authorized under FDA 510(k) and IVDR compliance, these controls are classified as Class II medical devices under regulation 864.5425.

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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 is the primary purpose of the HEMOSIL Low Abnormal Controlled and HEMOSIL Low Abnormal Control 2 in a clinical lab setting?

    These controls are designed for quality assurance in coagulation assays, specifically to simulate low abnormal coagulation parameters in citrated human plasma. They help verify the accuracy and reliability of coagulation analyzers, including those from Instrumentation Laboratory’s IL Coagulation and ELECTRA™ Systems, by ensuring the system performs correctly within the low abnormal range of test results.

  • Are the HEMOSIL Low Abnormal Controlled and HEMOSIL Low Abnormal Control 2 single-use or reusable, and what does that mean for handling?

    Both variants are single-use only, meaning each vial is intended for one-time use in a coagulation assay. This design minimizes the risk of contamination and ensures consistent, accurate results for each test. After opening or using, the control should be discarded, and a new vial should be used for subsequent tests.

  • Do these controls require special storage conditions, and what happens if they are not refrigerated?

    No special storage conditions are required beyond standard refrigeration. The controls are supplied as liquid plasma and should be stored refrigerated (typically between 2°C and 8°C) to maintain their integrity. While the device data does not specify consequences of improper storage, deviation from refrigeration could potentially affect the stability and accuracy of the control values over time.

  • What distinguishes the HEMOSIL Low Abnormal Controlled from the HEMOSIL Low Abnormal Control 2?

    The key difference lies in their intended use: the HEMOSIL Low Abnormal Controlled (Assayed) comes with predefined, standardized values for direct comparison against analyzer results, making it ideal for automated quality checks. In contrast, the HEMOSIL Low Abnormal Control 2 (Unassayed) is meant for manual verification, allowing labs to validate coagulation parameters without preassigned targets, providing flexibility for custom validation protocols.

  • What types of coagulation analyzers are compatible with these controls, and how do I confirm compatibility?

    These controls are explicitly designed for use on Instrumentation Laboratory’s IL Coagulation and ELECTRA™ Systems. Compatibility is confirmed by the manufacturer’s specifications, which align with these platforms. For other analyzers, it’s recommended to consult the device’s user manual or contact Instrumentation Laboratory directly to ensure proper functionality, as performance may vary across different systems.