(162 days)
The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
The in vitro diagnostic device presented in this 510K submission, STA® -Staclote dRVV Screen and STA® -Staclot® dRVV Confirm, is substantially equivalent to the IL Test LAC Screen and Confirm manufactured by Instrumentation Laboratories.
Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The submission implicitly uses "percent agreement" with a predicate device as its primary acceptance criterion for demonstrating substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Percent Agreement with predicate device (LAC Screen and Confirm manufactured by Instrumentation Laboratories) | 92% |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 90 plasma samples.
- Data Provenance: The plasmas were obtained from "patients with various clinical pathologies." The country of origin is not explicitly stated. The study appears to be retrospective, as samples from existing patients were collected and tested.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the summary. The study relies on agreement with a predicate device rather than an independently established expert ground truth for each sample being tested.
4. Adjudication Method
This information is not applicable/provided. The study focuses on agreement with a predicate device, not on adjudicating discrepancies between multiple readers or diagnostic methods for ground truth establishment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. This study is an in vitro diagnostic device (reagent kit) and does not involve human readers interpreting results in the same way, for example, a medical imaging AI would. The comparison is between the new device's results and those of a predicate device.
6. Standalone Performance Study
A standalone performance study was implicitly done in the sense that the device was used independently to generate results. However, its effectiveness was measured by agreement with a predicate device, which inherently involves a comparison. If "standalone" refers to performance against an absolute gold standard established independently (e.g., pathology), that was not the primary focus or method of proving substantial equivalence in this submission. The "92% agreement" figure is the standalone device's performance relative to the predicate.
7. Type of Ground Truth Used
The ground truth for the study was established through the results obtained from a predicate device (IL Test LAC Screen and Confirm). The "ground truth" here is essentially the performance of the legally marketed predicate device.
8. Sample Size for Training Set
The sample size for a "training set" is not applicable/provided. This device is a reagent kit, not a machine learning algorithm that requires a distinct training phase on a dataset. The 90 plasma samples constitute the test set used for the substantial equivalence study.
9. How Ground Truth for Training Set Was Established
This information is not applicable as there is no training set mentioned in the context of a machine learning model.
§ 864.8950 Russell viper venom reagent.
(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).