(543 days)
LupoTek Detectin VL and Correctin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.
PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.
LupoTek Detectin VL and LupoTek Correctin VL use Vipera lebetina venom rather than Vipera russelli (Russell's Viper) venom in the dRVVT assay for lupus anticoagulant. Vipera lebetina venom, like Russell's viper venom, will directly activate Factor X without requiring Factor VII. The activated Factor X in conjunction with Factors V, II, calcium ions and phospholipid will generate thrombin which converts fibrinogen to fibrin, producing a clot in the test system. LupoTek Detectin VL, the low phospholipid reagent, is designed as the screening reagent to detect a prolongation of the clotting time. LupoTek Correctin VL is the high phospholipid reagent that neutralizes the LA and corrects the clotting time to normal, confirming the presence of a Lupus Anticoagulant.
PlasmaCon LA is a lyophilized Lupus Anticoagulant (LA) positive plasma suitable for use as a quality control plasma for in vitro diagnostic assays in the clinical coagulation laboratory sensitive for the presence of LA
The provided text describes the LupoTek Detectin VL, LupoTek Correctin VL, and PlasmaCon LA devices, which are related to the detection of lupus anticoagulants (LA).
Here's an analysis of the acceptance criteria and the study as described in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for positive or negative agreement percentages. Instead, it presents the results of a comparative study to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is likely to be a high level of agreement with the predicate devices.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (LupoTek Detectin VL / Correctin VL) |
|---|---|---|
| Percent Positive Agreement | High agreement with predicate | 98% |
| Percent Negative Agreement | High agreement with predicate | 96% |
For PlasmaCon LA, the text states it is for use as an LA positive, abnormal quality control plasma to monitor diagnostic assays. Its performance is compared to a predicate device (American Diagnostica LAtrol Abnormal Control) based on similarities in intended use, constituent material, measurement principle, format, and analyte. Specific performance metrics like agreement percentages are not provided for PlasmaCon LA itself, as its role is a control.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for LupoTek Detectin VL / Correctin VL: 155 patient samples.
- Data Provenance: The text states "three sites" were used for analysis, indicating a multi-center study. The country of origin is not specified, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts used or their qualifications to establish ground truth. It implies that the predicate device's results (Stago DRVV Screen / Confirm kits) served as the reference standard for comparison.
4. Adjudication Method for the Test Set
The text does not specify any adjudication method. It describes a comparison between the investigational device and predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The described study compares the device's performance to a predicate device, not the improvement of human readers with or without AI assistance. The devices in question are diagnostic reagents, not AI-based image analysis tools or decision support systems.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was done. The described study evaluates the performance of the LupoTek Detectin VL / Correctin VL kits themselves in detecting lupus anticoagulants in patient samples by comparing their results directly to those of the predicate devices. There is no mention of human-in-the-loop performance in this context.
7. Type of Ground Truth Used
The ground truth was established by the results obtained from the predicate devices (Stago DRVV Screen / Confirm kits). This is a form of comparative effectiveness or reference standard based on an already marketed and accepted diagnostic method.
8. Sample Size for the Training Set
The text does not mention a training set in the context of device development or performance evaluation. This type of diagnostic reagent typically undergoes initial development and validation, but the reported study is a performance comparison for regulatory submission, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the reported study, this information is not applicable/provided.
§ 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).