(12 days)
Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.
Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
The provided document is a 510(k) summary for the Bio-Rad Liquichek Cardiac Markers Control LT. It is a submission to the FDA for a quality control material used in laboratories to monitor cardiac marker procedures. The document establishes substantial equivalence to a previously marketed device (Liquichek Cardiac Markers Control K961828) rather than detailing a study proving performance against acceptance criteria for a new device.
Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or available within this type of regulatory submission for a quality control material.
However, I can extract the relevant information based on the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance:
For a quality control material like this, the "acceptance criteria" and "reported device performance" are typically related to demonstrating that the new device has "substantially equivalent" characteristics to a predicate device. The document explicitly provides a comparison table against the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K961828) | Reported Device Performance (Liquichek Cardiac Markers Control LT) |
|---|---|---|
| Intended Use | To monitor the precision of a laboratory's specific cardiac markers procedures. | To monitor the precision of a laboratory's specific cardiac markers procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Analytes | Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, Troponin T | Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, Troponin T |
| Open Vial Claim | 20 Days at 2-8°C for all analytes; except Troponin T which is stable for 10 Days at 2-8°C | 20 Days at 2-8°C for all analytes; except Troponin T which is stable for 10 Days at 2-8°C |
| Differences (Troponin I Target Levels) | Troponin I is targeted at higher levels | Troponin I is targeted at lower levels |
Rationale for "Acceptance Criteria" here: In the context of a 510(k) for a quality control material, the acceptance criteria for a new device are primarily its ability to match the essential characteristics and performance of a legally marketed predicate device, demonstrating that it is "substantially equivalent." The key difference noted (Troponin I targeted at lower levels) is considered acceptable as it still serves the intended purpose of a control, just at a different target level. The FDA's approval letter confirms their determination of substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. For a quality control material intended to monitor laboratory precision, testing would typically involve evaluating the stability, homogeneity, and analyte values across multiple lots and over time, compared to established reference methods or predicate controls. The document does not provide details on the specific sample sizes used for such internal characterization studies.
- Data Provenance: Not specified in terms of country of origin. The submission is made by Bio-Rad Laboratories, located in Irvine, California, USA. The studies would have been conducted internally by Bio-Rad. It is an internal characterization study for the control material itself, rather than a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For a quality control material, the "ground truth" (i.e., the assigned values for analytes) is established through rigorous analytical testing using reference methods and comprehensive characterization studies performed by qualified laboratory personnel at the manufacturer's facility, not by external experts or adjudication panels in the way a diagnostic algorithm might be evaluated.
- Qualifications of Experts: Not applicable in the context of an adjudication panel. The analyses would be performed by qualified laboratory scientists and technicians.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic outcomes. For a quality control material, the "true" values are determined by analytical methods, not by expert consensus.
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:
- MRMC Study: No. This is a quality control material, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was performed, and the concept of "human readers improving with AI" does not apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical quality control material, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For a quality control material, the "ground truth" refers to the target or assigned values for each analyte within the control. This is established through analytical testing using validated reference methods and internal laboratory characterization studies, including repeat measurements on multiple instruments, potentially against reference materials, and stability studies. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set. The values and characteristics of the control are determined through laboratory characterization, not by training an AI model.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.
§ 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.