(135 days)
GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.
GradiPlasma LA High and Low are preparations of fresh human citrated plasma with added buffers and stabilizers, for in vitro diagnostic use. The controls are prepared from patients diagnosed with Lupus Anticoagulant and lyophilized in two levels (High and Low) and two volumes (0.5ml and 1.0ml).
The provided document describes the GradiPlasma LA High and Low, which are Lupus Anticoagulant Quality Control Plasmas. The FDA determined the device to be substantially equivalent to a predicate device, Verify® LA Control (K961370).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria appear to be related to the within-run variance of the control plasmas, demonstrating similar performance to the predicate device and being below a specified threshold. Stability after reconstitution and single freeze-thaw were also criteria.
| Acceptance Criteria | Reported Device Performance (GradiPlasma LA) |
|---|---|
| Within-run %CV for LA SCREEN (DRVVT) | High: 1.7% |
| Low: 0.8% | |
| Predicate (Verify® LA): 0.8% | |
| Within-run %CV for LA CONFIRM (DRVVT) | High: 1.4% |
| Low: 0.9% | |
| Predicate (Verify® LA): 2.3% | |
| Target Specification for Within-run %CV | Well below 5% |
| Reconstituted Stability | Stable for 8 hours at 2-8℃ (using Dade Behring BCT analyzer) |
| Freeze-thaw Stability | Able to be freeze-thawed once (using Dade Behring BCT analyzer) |
| Equivalence to Predicate Device (Overall) | Demonstrated overall performance characteristics, intended use, safety, and effectiveness similar to Verify® LA Control. (Conclusion stated in document) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample sizes (e.g., number of runs, number of replicates, or distinct patient samples) used for the comparative performance study. It mentions "a comparative performance study."
- Data Provenance: The studies were performed using IL ACL300, IL MLA 800, and Dade Behring BCT instruments. The submitter is Gradipore Ltd, Australia, suggesting the data likely originates from Australia. The study appears to be prospective in nature, as it describes the testing of the new device against the predicate.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not provided in the document. The study focuses on the performance of control plasmas in laboratory assays rather than on diagnostic interpretations by experts. The "ground truth" for these control plasmas is their known positive status for Lupus Anticoagulant, established during their preparation from diagnosed patients.
4. Adjudication method for the test set:
This information is not applicable and not provided. The study involves objective measurements from laboratory instruments, not human interpretation that would require adjudication.
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 device is an in-vitro diagnostic control plasma, not an AI-powered diagnostic tool requiring human reader studies.
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 is not an algorithmic device; it is a laboratory reagent.
7. The type of ground truth used:
The ground truth for the GradiPlasma LA controls is their known status as positive for Lupus Anticoagulant (High and Low levels), derived from patients diagnosed with Lupus Anticoagulant. This is an inherent property of the control material, established during its manufacturing process.
8. The sample size for the training set:
This information is not provided and not applicable in the context of this device. It is a control plasma, not a machine learning algorithm that requires a training set. The "training" for such a device would be its manufacturing and characterization process.
9. How the ground truth for the training set was established:
This information is not provided and not applicable for the same reasons as #8. The ground truth (known positive LA status) is established during the selection of plasma from diagnosed patients for manufacturing.
§ 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.