(93 days)
Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:
- Prothrombin time (PT)
- Activated partial thromboplastin time (APTT)
- Thrombin time (TT)
- Batroxobin time
- Fibrinogen
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
- Inhibitors: Antithrombin III, protein C, protein S, α2 –antiplasmin
- Plasminogen
- Lupus anticoagulants
- Factor V Leiden
ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.
Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and stabilized with HEPES buffer solution.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reconstituted stability within assigned values for: | |
| 4 hours at 15 to 25°C | Met the acceptance criteria of recovering within the assigned values |
| 4 weeks at -20°C or below | Met the acceptance criteria of recovering within the assigned values |
Study Details
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "pooled human plasma" for both Control Plasma N and ProC® Control Plasma, and "rabbit plasma" additionally for ProC® Control Plasma, but doesn't specify the number of samples or their origin. The study appears to be prospective, as it involves testing the stability of the new control plasmas.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study assessing diagnostic performance or requiring expert consensus for ground truth. The "ground truth" for this device would be its expected performance within established ranges for coagulation parameters.
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Adjudication method for the test set: Not applicable. There's no subjective assessment requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a stability study for in vitro diagnostic (IVD) control plasmas, not a comparative effectiveness study involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's performance (stability) was evaluated directly without human interpretation of clinical cases. However, this isn't an "algorithm-only" study in the typical AI context; it's a performance study of a laboratory control.
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The type of ground truth used: The "ground truth" here refers to the pre-established analytical values and expected stability of the control plasmas. The study assesses if the reconstituted plasmas remain within these assigned values over time under various storage conditions.
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The sample size for the training set: Not applicable. This device is a control plasma, not an AI/ML algorithm that requires training data.
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How the ground truth for the training set was established: Not applicable.
§ 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.