(11 days)
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
This 510(k) submission (K062431) for HemosIL Liquid Antithrombin is a "Special 510(k)" which indicates that the device being submitted is not materially different from a previously cleared device. The purpose of this submission is to modify the "Expected Values" section of the product inserts to reference a normal range from published literature and reinforce the need for each laboratory to establish its own normal reference range.
Therefore, the submission does not contain new performance studies or data to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device (K033775 HemosIL Liquid Antithrombin) and the update to labeling information.
Because no new performance study data is presented, much of the requested information cannot be provided. However, based on the provided document, here's what can be inferred or explicitly stated:
Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for a labeling change and not a new device or significant modification requiring new performance data, there are no specific acceptance criteria or reported device performance metrics presented in this document. The device relies on the performance validated for the predicate device, K033775 HemosIL Liquid Antithrombin.
Details of the Study
As this is a Special 510(k) for a labeling change, no new study proving device performance is included in this document. The submission focuses on updating the "Expected Values" section based on published literature and clarifying the need for local laboratory validation of normal ranges.
Therefore, the following points cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not applicable, no new test set data presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no new ground truth established for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no new test set data presented.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is an in vitro diagnostic device, not an AI-assisted diagnostic product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is an in vitro diagnostic device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the predicate device, the ground truth would typically be established through method comparisons to recognized reference methods or clinical outcomes studies, but this information is not present in this document. The current submission updates expected values based on published literature.
- The sample size for the training set: Not applicable, no new model training is performed.
- How the ground truth for the training set was established: Not applicable, no new model training is performed.
Summary of Changes and Basis for Clearance:
The core of this submission is the modification of the "Expected Values" section in the product inserts. The change is:
- From: Implied standard normal ranges.
- To: Explicitly stating that "Antithrombin activity levels in healthy individuals are approximately in the range of 83 – 128%," and more importantly, adding the directive "Due to many variables which may affect results, each laboratory should establish its own normal range." This statement is supported by a published literature reference: "Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336."
The FDA's clearance (SEP - 1 2006) for this Special 510(k) indicates that they determined the device with this modified labeling is "substantially equivalent" to the previously cleared HemosIL Liquid Antithrombin (K033775). This is because the underlying device formulation and performance characteristics are unchanged, and the modification is limited to ensuring appropriate interpretation of results by emphasizing localized validation of reference ranges, a common best practice in clinical laboratory diagnostics.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).