(24 days)
An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes listed in the package insert.
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek™ Cardiac Markers Control LT device, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document describes a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Therefore, the "acceptance criteria" are related to the stability and integrity of the control material itself, rather than diagnostic performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Open Vial Stability | Once thawed and opened, all analytes stable for 7 days when tightly capped at 2-8°C. Exceptions: Troponin I and Homocysteine stable for 10 days. |
| Refreezing | Control material should not be refrozen after thawing. |
| Shelf Life | Two years when stored at -20°C or colder. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the "sample size" in terms of a number of patient samples, as this is a control material. Instead, stability studies were performed. The sample size for these studies is not specified (e.g., how many vials were tested, how many replicates).
- Data Provenance: Not specified, but likely Bio-Rad Laboratories' internal testing, which is based in Irvine, California, USA.
- Retrospective or Prospective: The stability studies described are prospective in nature ("Real time studies will be ongoing to support the shelf life of this product").
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 is not applicable to a quality control material. The "ground truth" for a control material is its expected concentration values for various analytes, which are established by the manufacturer through rigorous analytical methods using reference materials and internal standards. Experts are not typically involved in establishing the "ground truth" of a control material in the same way they would for a diagnostic test interpreting patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies. For a quality control material, the performance is measured against established analytical stability criteria.
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
Not applicable. This is a quality control material, not an AI-powered diagnostic device, and thus no human reader studies are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device. It's a laboratory reagent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" for stability studies is based on:
- Reference analytical methods: Ensuring the analytes remain within specified concentration ranges over time under various storage conditions.
- Manufacturer's specifications: The established target ranges and acceptable variations for each analyte within the control material.
- Stability testing protocols: Standardized procedures to assess degradation or changes in analyte concentration.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.