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Hemochron Jr. Citrate APTT Cuvette

by Itc, Inc.

510(k) K014008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK014008 Date24 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0937-2014 FDA Class II initiated 19 Dec 2013

    ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

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  • Withdrawn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
GFO
Device Class
Class II
Regulation
21 CFR Part 864.7925
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Hemochron Jr. Citrate APTT Cuvette is a disposable, unitized microcoagulation test device designed for performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT) assay. It is intended for use in monitoring low-dose heparin anticoagulation, specifically up to 1.5 units per milliliter. This device falls under the classification of an Activated Partial Thromboplastin, as defined by regulatory nomenclature, and is used in hematology diagnostics to assess blood coagulation parameters.

This cuvette is supplied as a single-use, sterile item for in vitro diagnostic use in clinical laboratories or point-of-care settings. It is classified as a Class II medical device under FDA regulations (21 CFR 864.7925) and requires compliance with applicable manufacturing and quality standards. The device is intended for use with the Hemochron Jr. coagulation analyzer and is not compatible with MRI environments. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance integrity.

Questions

AI-generated answers, 20 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 scenarios is the Hemochron Jr. Citrate APTT Cuvette specifically designed to monitor?

    This cuvette is designed for monitoring low-dose heparin anticoagulation, particularly in patients receiving doses up to 1.5 units per milliliter. It performs a quantitative Activated Partial Thromboplastin Time (APTT) assay, which helps assess blood coagulation parameters in hematology diagnostics, ensuring safe and effective anticoagulation management.

  • Is the Hemochron Jr. Citrate APTT Cuvette reusable or single-use, and how does this affect its use?

    The device is explicitly labeled as a disposable, single-use item, ensuring sterility and preventing cross-contamination between patients. This design aligns with in vitro diagnostic best practices, requiring a new cuvette for each test to maintain accuracy and compliance with clinical laboratory or point-of-care protocols.

  • What analyzer is required to use the Hemochron Jr. Citrate APTT Cuvette, and are there any environmental restrictions?

    This cuvette is intended exclusively for use with the Hemochron Jr. coagulation analyzer. It is not compatible with MRI environments, meaning it should not be used in areas where magnetic resonance imaging is performed, as the device may be affected by electromagnetic interference.

  • How should the Hemochron Jr. Citrate APTT Cuvette be stored to preserve its performance and sterility?

    Storage and handling must follow the manufacturer’s guidelines to maintain sterility and performance integrity. While specific conditions aren’t detailed here, typical practices for single-use diagnostic devices—such as keeping the cuvettes in a sealed, dry environment away from direct light or extreme temperatures—are recommended to ensure reliability before use.