HemosIL Liquid Anti-Xa

• • Ongoing Z-2323-2025 FDA Class II ·initiated 3 Feb 2025

  Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

• • Ongoing Z-1020-2025 FDA Class II ·initiated 18 Dec 2024

  Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

510(k) Number

K213464 ↗

FDA product code

KFF

Device class

Class II

Regulation

21 CFR Part 864.7525

Advisory committee

Hematology

FDA decision

SESE Substantially Equivalent

• HemosIL Silica Clotting Time

  Class II

  FDA 510(k) K253957 Active Cleared 9 Jan 2026

• GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005 Open recall

  Class II

  FDA 510(k) ×4 Active Cleared 14 Dec 2016 GUDID on market

• GEM CVP (Calibration Validation Product) Level 4 00024001814

  Class I

  CE/IVDR IVDR 727804 Active Valid to Oct 2031 FDA 510(k) K052121 Active Cleared 21 Oct 2005 +1authorizations

• HemosIL RecombiPlasTin 2G (8 mL) 00020002950

  Class II

  CE/IVDR GUDID on market

• ChemSTAT Hematocrit Evaluator 1 00044000104

  Class II

  GUDID on market

• Coatest SP FVIII 82 4086 63

  Class II

  FDA 510(k) K042576 Active Cleared 2 Dec 2004 GUDID on market

See all devices from Instrumentation Laboratory Company →

• What is the HemosIL Liquid Anti-Xa used for in clinical practice?

  The HemosIL Liquid Anti-Xa is specifically designed for measuring anti-Xa activity in plasma, allowing clinicians to quantify the anticoagulant effect of low molecular weight heparins and unfractionated heparin during patient treatment. This helps monitor and adjust dosing to ensure safe and effective anticoagulation, particularly in settings like surgery or acute care where precise heparin management is critical.

• How is the HemosIL Liquid Anti-Xa supplied, and what are its storage requirements?

  The HemosIL Liquid Anti-Xa is supplied as a liquid reagent, ready for immediate use in clinical laboratories. It requires standard refrigeration between 2–8°C and is intended for single-use only, meaning each vial is designed for one test cycle. No additional storage precautions beyond refrigeration are needed, making it convenient for routine use.

• Can this device be reused, or is it meant for single applications?

  The HemosIL Liquid Anti-Xa is explicitly labeled for single-use only, meaning each vial should not be reused after opening or testing. This design ensures accuracy and sterility for each measurement, reducing the risk of contamination or inaccurate results from repeated use.

• What regulatory pathways does the HemosIL Liquid Anti-Xa follow, and which committees oversee its classification?

  The HemosIL Liquid Anti-Xa is authorized under FDA 510(k) clearance (K213464) and complies with the In Vitro Diagnostic Regulation (IVDR). It falls under the Hematology advisory committee (HE) and is classified as a Class II device (device class=2) for in vitro diagnostic assays, particularly for heparin monitoring. The submission was reviewed under the Hematology (HE) panel.