(59 days)
VALIDATE® VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analyte: total 25 (OH) vitamin D (VIT D).
Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and study proving the device meets them.
The document is a 510(k) summary for the VALIDATE® VIT D Calibration Verification / Linearity Test Kit. It describes the device, its intended use, and states that it is "as safe and effective as the predicate device." However, it does not include the following crucial information that you asked for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Information on a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory submission indicating substantial equivalence to a predicate device, rather than a detailed scientific study report outlining performance metrics against specific acceptance criteria.
§ 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.