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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.

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.

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GradiLeiden V is a simple functional clotting test system intended for screening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.

The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.

Here's a breakdown of the acceptance criteria and study information for the GradiLeiden V Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Size: 164 individuals (This number includes 35 oral anticoagulated plasmas, 21 heparinized plasmas, and 12 Lupus Anticoagulant positive plasmas, alongside other samples).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Australia, suggesting the data may originate from there or an international collaboration. It describes the comparison as "GradiLeiden V was compared against the predicate device in a series of clotting assays," implying a prospective approach for the comparison study, but the source of the patient samples (retrospective/prospective collection) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The ground truth was established by "DNA analysis," which implies a laboratory-based, molecular diagnostic method rather than expert interpretation of a diagnostic image or clinical presentation.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on DNA analysis, not expert consensus requiring adjudication.

4. 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 not an AI-based diagnostic device; it's a laboratory clotting test. The comparison was between two laboratory tests (GradiLeiden V and Coatest APC Resistance V) with ground truth established by DNA analysis.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance was done for the GradiLeiden V device. Its performance was evaluated against DNA analysis as the ground truth.

6. The type of ground truth used:

   • DNA analysis (specifically mentioned: "all results confirmed by DNA analysis"). This is a highly accurate, molecular diagnostic method for determining Factor V Leiden status.

7. The sample size for the training set:

   • Not explicitly stated. The document focuses on the test set used for validation. The device's cut-off of 1.57 was "obtained by ROC analysis," which implies a dataset was used to determine this threshold, but whether this constitutes a distinct "training set" in a machine learning sense, or if it was part of the overall validation process, is not detailed.

8. How the ground truth for the training set was established:

   • Assuming the "training set" (or data used for ROC analysis) was drawn from similar sources as the test set, the ground truth would have been established by DNA analysis.

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