(11 days)
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate.
This documentation is a 510(k) premarket notification for a modification to an existing device, the HemosIL Protein C. The core device itself remains unchanged; the submission is specifically about modifying the "Expected Values" section of the product insert. Therefore, the traditional acceptance criteria and performance study as one might expect for a new device or significant modification are not present in this document.
Here's an analysis based on the provided text, focusing on the reason for this specific submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the nature of this 510(k) submission, the "acceptance criteria" are not related to a specific numerical performance metric of the device's accuracy or precision. Instead, the acceptance criteria implicitly revolve around:
- Consistency with established medical literature: The modified insert references a published normal range.
- Emphasis on local laboratory validation: The insert reinforces the need for each laboratory to establish its own normal range due to variables.
- Lack of material difference: The core regulatory acceptance criterion for this submission is that the device with the modified insert is not materially different from the FDA-cleared predicate device K980875.
| Acceptance Criterion (Implicit for this type of submission) | Reported Device Performance (as per submission) |
|---|---|
| The device, with the modified product insert, is not materially different from the predicate device K980875. | The submission asserts this directly: "HemosIL Protein C with the modified Expected Values section in the product insert is not materially different from the FDA cleared device." The FDA's clearance implies agreement with this statement for the specific change submitted. The core technology and function of the assay remain identical. |
| The modified "Expected Values" section accurately reflects established medical knowledge regarding Protein C levels. | The insert states: "Protein C activity levels in healthy individuals are approximately in the range of 70 - 140%. Protein C levels are low in neonates and increase to adult levels during adolescence." This is supported by a citation from published literature: 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 modified "Expected Values" section appropriately warns users about the need for local laboratory validation of normal ranges. | The insert clearly states: "Due to many variables which may affect results, each laboratory should establish its own normal range." |
No traditional performance study (e.g., sensitivity, specificity, accuracy against a gold standard) was conducted or presented in this document because the device itself and its underlying technology are not changing. The study referenced (Kottke-Marchant K, Comp P. et al.) is external published literature used to support the content of the modified insert, not a study conducted by the device manufacturer for this specific 510(k).
The rest of the questions pertain to performance studies and are not applicable to this specific submission, which is purely an administrative change to labeling based on existing knowledge.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no new performance study was conducted. The reference information is from published medical literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no new performance study was conducted. The ground truth for the "Expected Values" is based on the consensus found in the cited medical literature, which is peer-reviewed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new performance study was conducted.
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 test, not an AI-enabled diagnostic imaging device or similar system involving human interpretation of results in a comparative study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The HemosIL Protein C is a laboratory assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the modified label content, the ground truth is expert consensus/published medical literature.
8. The sample size for the training set: Not applicable, as no new performance study or AI algorithm was being trained.
9. How the ground truth for the training set was established: Not applicable, as no new performance study or AI algorithm was being trained.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).