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• HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
• HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
• HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
• · HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
  For in vitro diagnostic use.

HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.

• 1. Factor Xa is neutralized by heparin-antithrombin complex.
• 2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
• HemosIL Heparin Calibrators .
  Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
• HemosIL LMW Heparin Controls (Assayed) .
  Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
• HemosIL UF Heparin Controls (Assayed) .
  Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.

HemosIL Liquid Heparin Assay, Controls, and Calibrators - Acceptance Criteria & Study Summary

This document describes the acceptance criteria and supporting studies for the HemosIL Liquid Heparin Assay, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls, and HemosIL UF Heparin Controls, as extracted from the provided 510(k) summary (K090209).

1. Acceptance Criteria and Reported Device Performance

The 510(k) submission primarily demonstrates substantial equivalence through method comparison studies and precision assessments. The acceptance criteria for substantial equivalence are implicitly defined by comparing the new device's performance to that of predicate devices and demonstrating acceptable precision.

The following table summarizes the reported device performance, particularly focusing on precision and method comparison results, which serve as the evidence for meeting implied acceptance criteria for assay performance characteristics relevant to quantitative diagnostic devices. Specific, explicit acceptance criteria (e.g., "CV % must be

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