(26 days)
Liguichek Cardiac Troponins Control is intended for use as an assayed quality control server to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
- Troponin I
- Troponin T
Liquichek Cardiac Troponins Control is a trilevel liquid control prepared from human protein with added constituents of human and animal origin, stabilizers and preservatives. Liquichek Cardiac Troponins Control is intended for use as an assayed quality control to monitor the precision of Troponin I and Troponin T in laboratory testing procedures.
The provided text describes a 510(k) summary for the "Liquichek Cardiac Troponins Control" device. This is a quality control material intended for use in laboratory testing procedures for Troponin I and Troponin T. This type of device does not involve an AI algorithm or human-in-the-loop performance, but rather relates to the stability and performance of a diagnostic control solution.
Therefore, many of the requested points, such as AI-specific study details, expert qualifications, adjudication methods, MRMC studies, and ground truth for training sets, are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thawed and Opened Stability | 25 days at 2 to 8 °C | Met acceptance criteria |
| Frozen Aliquot Stability Studies | 30 days at -20°C to -70 °C | Met acceptance criteria |
| Shelf Life Stability | 18 months at -20°C to -70 °C | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of units or measurements) used for the stability studies. It mentions "multiple replicate analyses" for value assignment and "a representative sampling of the lot of product" for tests listed, but no specific numbers are given.
Data provenance is not specified beyond being generated by "the manufacturer and/or independent laboratories."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material, not a diagnostic device that requires expert-established ground truth for interpretation. Its performance is evaluated through analytical stability studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is typically used for subjective diagnostic assessments, which is not the case for this quality control material.
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 device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is its stability and performance according to pre-defined analytical specifications. These specifications are based on established laboratory practices for quality control materials, which aim to ensure the material remains stable and provides consistent results over time within acceptable analytical variations. The document refers to "multiple replicate analyses that meet acceptance criteria" as the basis for initial value assignment and stability claims.
8. The sample size for the training set
Not applicable. This type of device does not involve a training set as it's not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. This type of device does not involve a training set.
§ 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.