(42 days)
Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).
Liquichek BNP Control is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.
This document describes a 510(k) premarket notification for the "Liquichek BNP Control" device. The acceptance criteria and supporting studies are focused on the device's stability and its intended use as a quality control serum for monitoring the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability: | |
| All analytes stable for 20 days at 2 to 8°C | All analytes are stable for 20 days at 2 to 8°C. |
| Shelf Life Stability: | |
| 2 years at -20°C to -70°C | The product has a shelf life of 2 years at -20°C to -70°C. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation with patient samples. The studies discussed are related to the intrinsic stability of the control material itself. Therefore, sample sizes for a traditional test set or its provenance (country, retrospective/prospective) are not applicable or provided in this regulatory document.
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 from patient data. The "ground truth" for this product relates to its stability and consistency over time, which is determined through laboratory testing of the control material itself.
4. Adjudication method for the test set
Not applicable. As noted above, this is a quality control material, not a diagnostic device evaluated with patient samples requiring expert adjudication.
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 and is not an AI-powered diagnostic tool, nor does it involve human readers interpreting results in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical quality control serum, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this quality control device, the "ground truth" for the stability studies would be defined by the expected stable concentration of BNP over time, under specified storage conditions. This is established through internal scientific methods and validated analytical procedures by the manufacturer (Bio-Rad Laboratories) using reference methods or internal standards to measure BNP concentration in the control material at various time points.
8. The sample size for the training set
Not applicable. This device is a manufactured control material undergoing stability testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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.