(31 days)
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
The provided text is a 510(k) summary for a control plasma device (STA® - Control LA 1+2), not a diagnostic algorithm or AI-powered device. Therefore, much of the requested information (like AI performance metrics, training/test sets, expert adjudication, MRMC studies) is not applicable to this submission.
However, I can extract the relevant information regarding the device's intended use and the general nature of its "performance" as a control product.
Device: STA® - Control LA 1+2 (Lupus Control Plasmas)
1. A table of acceptance criteria and the reported device performance
For a control plasma, the "acceptance criteria" generally involve demonstrating that the control material performs as expected (LA positive and LA negative) when tested with the specified diagnostic assays and that it is substantially equivalent to a predicate device. The performance is typically assessed by its reactivity in the target assays.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provides LA-negative control plasma that tests negative with specified LA detection kits. | The device provides an LA-negative plasma intended for quality control of LA testing using STA® -Staclot® dRVV Screen, STA® -Staclot® dRVV Confirm, and Staclot® LA kits. (The document implies this functionality based on its description and intended use, but specific numerical performance data like expected ranges or negativity rates are not provided in this summary.) |
| Provides LA-positive control plasma that tests positive with specified LA detection kits. | The device provides an LA-positive plasma intended for quality control of LA testing using STA® -Staclot® dRVV Screen, STA® -Staclot® dRVV Confirm, and Staclot® LA kits. (Similar to the LA-negative control, specific numerical performance data like expected ranges or positivity rates are not provided in this summary, but its function as a positive control is stated.) |
| Substantial Equivalence to Predicate Device | The FDA reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate device, Cryocheck Lupus Positive Control (K952623). This implies that the performance characteristics, intended use, and technological characteristics are similar enough to the predicate that it performs as intended for its stated quality control purpose. (Specific comparative performance data is not included in this 510(k) summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a control material, "test set" would typically refer to the various batches of the control manufactured and tested, or the number of runs/analyses performed to establish its characteristics and lot-to-lot consistency. The summary does not disclose the specifics of these studies.
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)
This information is not applicable and not provided. This device is a control material for laboratory tests, not a diagnostic or AI algorithm requiring expert adjudication of ground truth for patient data. Its "ground truth" is defined by its known formulation (LA positive vs. LA negative) and its reactivity with specific diagnostic assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As explained above, this device does not involve human interpretation of medical images or data that would necessitate an adjudication method for a test set.
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 information is not applicable and not provided. This is not an AI-powered device or a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This device is a control material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this control device, the "ground truth" is its known composition as either LA-positive or LA-negative plasma, and its established reactivity when tested with specific Lupus Anticoagulant detection kits. It is a manufactured reagent designed to elicit a specific, known response.
8. The sample size for the training set
This information is not applicable and not provided. This device is a manufactured control plasma, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As above, there is no "training set" for this product in the AI context.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.