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HemosIL ProClot is an automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems. Protein C deficiency is associated with recurrent venous thrombosis and pulmonary embolism, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

The ProClot kit is a functional clotting Protein C test, based on the prolongation of an APTT assay in presence of activated Protein C. The use of the APTT test to measure the anticoagulant effect of activated protein C is due to its sensitivity to FV and FVIII levels. Activated Protein C in plasma samples is generated by Protac , a rapid in vitro Protein C activator derived from the venom of the copperhead snake Agkistrodom contortrix contortrix.

The provided text describes a Special 510(k) submission for the HemosIL ProClot device, focusing on a modification to its product insert regarding expected values. This submission is for a regulatory change, not a new device or a clinical performance study to establish new acceptance criteria.

Therefore, the information required to populate the fields regarding acceptance criteria and a study proving the device meets them is not available in the provided document. The submission is a request to modify the labeling based on published literature and reinforce the need for laboratories to establish their own normal ranges, rather than presenting original study data for performance validation against acceptance criteria.

However, I can extract information relevant to the device's regulatory context and the proposed change:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or new reported device performance data are provided in this document. The submission is about a labeling change, not a performance validation study.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. No test set data is presented as part of this submission. The change is based on existing knowledge and literature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not done or described in this submission. The document focuses on regulatory approval for a labeling change, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a functional clotting assay kit, not an algorithm.

7. Type of Ground Truth Used:

• Literature-based. The information about expected values, including the normal range of 70-140% and low levels in neonates, is directly referenced from a published pathology and laboratory medicine journal article:
  • Kottke-Marchant K, Comp P. Laboratory Issues in Diagnosing Abnormalities of Protein C, Thrombomodulin, and Endothelial Cell Protein C Receptor, Arch Pathol Lab med 2002; 126:1337-1348.
  • The "ground truth" for the modified expected values section is therefore based on established medical literature.

8. Sample Size for the Training Set:

• Not applicable. No training set for an algorithm or new device performance data is described. The device is a chemical reagent kit.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

Summary of the Document's Purpose:

The document concerns a Special 510(k) submission for the HemosIL ProClot device. The core reason for this submission is to modify the "Expected Values" section of the product insert. This modification involves:

• Referencing a normal range (70-140%) from published literature.
• Reinforcing the critical need for each individual laboratory to establish its own normal (reference) range due to the inherent variability in results.

The submission states that the device with the modified insert is not materially different from the previously FDA-cleared device (K912711 HemosIL ProClot). Therefore, no new performance studies (like those requiring acceptance criteria, test sets, or ground truth establishment) are presented or required for this type of regulatory submission. The FDA's letter (K070635) confirms substantial equivalence to the predicate device based on the proposed labeling change.

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