(59 days)
Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Tumor Marker Control, a trilevel liquid control is prepared from human source material with added constituents of human and animal origin, stabilizers and preservatives.
Here's a summary of the acceptance criteria and the study details for the Liquichek Tumor Marker Control, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Thawed and Opened Stability | 10 days at 2 to 8 °C (Met acceptance criteria) |
| Thawed and Unopened Stability | 15 days at 2 to 8 °C (Met acceptance criteria) |
| Shelf Life Stability | 28 months at -20°C to -50°C (Met acceptance criteria) |
Study Details
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" for value assignment, but no specific number of samples or details on provenance beyond the manufacturer and/or independent laboratories. The document indicates the human source material used to manufacture the control was tested by FDA accepted methods and found non-reactive for specific viruses.
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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 for this type of device. The study is for stability claims of a quality control material, not for diagnostic accuracy requiring expert consensus on clinical cases. Ground truth for control materials is typically established through precise analytical methods and value assignment processes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This study does not involve adjudication of expert readings or clinical interpretations.
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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 a stability study for a quality control material, not an AI-powered diagnostic device or 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: Not applicable. This is a control material, not an algorithm.
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The type of ground truth used:
- Value Assignment: The mean values and ±3SD ranges printed in the product insert were derived from replicate analyses using manufacturer supported reagents and a representative sampling of the product. These values serve as the established "truth" for monitoring precision.
- Stability Studies: For stability, the ground truth is the initial established value of the control material, against which subsequent measurements over time (under various conditions) are compared to ensure they remain within acceptable ranges. The acceptance criteria themselves define the acceptable deviation from this established truth.
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The sample size for the training set: Not applicable. This device is a quality control material and does not involve artificial intelligence or machine learning that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.