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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:

2. Sample size used for the test set and the data provenance: Not applicable, no new test set data presented.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no new test set data presented.
5. 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.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable, no new model training is performed.
9. 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.

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HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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. For in vitro diagnostic use.

HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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.

The HemosIL Liquid Antithrombin XL device is a modified version of the HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes. The modification does not alter the fundamental scientific technology or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma. It is intended as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

1. Table of acceptance criteria and the reported device performance:

The provided document describes performance metrics related to precision and method comparison but does not explicitly state pre-defined acceptance criteria (e.g., "CV must be Y%"). Instead, it presents the results of these studies. For the method comparison, the results are presented in a highly obfuscated and unreadable table due to OCR errors.

However, based on standard laboratory practice for diagnostic assays, the reported precision (CV%) values demonstrate acceptable performance for an Antithrombin assay, especially given the range of AT levels tested. The predicate device (HemosIL Antithrombin K980499) serves as the benchmark for substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Precision Studies:
  • For Normal, Low Abnormal, and High Abnormal control levels, the sample size (n) for each level was 60.
  • Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based performance evaluations, likely retrospective as they involve control plasmas rather than patient samples for the precision part.
• Method Comparison Study:
  • The sample size for the method comparison study is not explicitly stated in the readable portion of the provided text. The table intended to present this data is corrupted.
  • Data provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" often refers to reference methods or clinically established values for the analytes in the control or patient samples. The document focuses on comparing the new device to a predicate device and evaluating its precision, not on new clinical diagnoses established by experts.

4. Adjudication method for the test set:

This information is not applicable to this type of study for an in vitro diagnostic device where the "truth" is typically laboratory-derived values or predicate device results, not expert consensus on interpretations.

5. 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:

This is not applicable. The HemosIL Liquid Antithrombin XL is an automated chromogenic assay, not an imaging device or AI-driven diagnostic tool that relies on human readers or interpretations. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is an automated laboratory assay, which by its nature operates in a "standalone" fashion (algorithm/reagent/instrument only) to produce a quantitative result. The performance data provided, specifically precision and method comparison, represent this standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the primary output of the assay.

7. The type of ground truth used:

• Precision Studies: The "ground truth" for precision is the mean Antithrombin (% AT) value established for each control level (Normal, Low Abnormal, High Abnormal). This is typically determined through repeated measurements and confirmation with established methods.
• Method Comparison Study: The "ground truth" for the modified device (HemosIL Liquid Antithrombin XL) was the results obtained from the legally marketed predicate device (HemosIL Antithrombin K980499). The study aimed to show substantial equivalence to this predicate.

8. The sample size for the training set:

For an in vitro diagnostic assay like this, there isn't typically a "training set" in the machine learning sense. The assay is based on chemical reactions and photometric detection. The development and optimization of the reagent volumes and assay parameters would involve extensive experimentation and optimization, but not a distinct "training set" of data in the way an AI algorithm is trained. The reported values for precision are from performance studies, not "training."

9. How the ground truth for the training set was established:

As indicated above, the concept of a "training set" and associated "ground truth" in the machine learning context does not directly apply to the development and validation of this chemical assay. The "ground truth" for optimizing the assay parameters would be the known concentrations of Antithrombin in reference materials and controls, used to ensure accuracy and precision.

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