(19 days)
Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).
Liquichek Elevated CRP Control is prepared from human serum with added constituents of human and animal origin, stabilizers, and preservatives. This product is provided in liquid form.
The provided document, K042837, is a 510(k) Pre-Market Notification for the "Liquichek Elevated CRP Control" device. This device is a quality control material intended to monitor the precision of laboratory testing for C-Reactive Protein (CRP).
The document details the device's characteristics and compares it to a predicate device, focusing on its intended use, form, matrix, and preservatives. Crucially, it discusses stability studies as the primary evidence for the device meeting its performance claims.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are related to its stability, specifically its shelf life and open vial stability. The reported device performance is that it meets these stability claims.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open vial stability (after opening) | 30 days at 2°C to 8°C |
| Shelf life stability (unopened) | 3 years at -10°C to -70°C |
Study Proving Device Meets Acceptance Criteria
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Elevated CRP Control."
Unfortunately, the document does not provide detailed information about the study itself, such as the methodology, sample size, data provenance, ground truth establishment, or any direct comparative effectiveness study. It only states that "All supporting data is retained on file at Bio-Rad Laboratories."
Therefore, based solely on the provided text, the following information cannot be extracted:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.
- 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): Not applicable for a stability study of a quality control material. The "ground truth" would likely be laboratory measurements of CRP concentration over time under specified conditions.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a stability study.
- 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: This is not an AI/imaging device, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a quality control material, the ground truth for stability would be the measured concentration of CRP at various time points under controlled storage conditions, assessed against a defined reference method or expected range. This is inherently a chemical/analytical measurement, not an expert opinion or pathology.
- The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document explicitly states that stability studies were conducted to determine the open vial and shelf life stability, and the results of these studies demonstrated that the device meets its claimed stability periods. However, the details of these studies are not disclosed within the document itself, only that the data is on file with the manufacturer.
§ 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.