(567 days)
A calibration or control fluid to be used in conjunction with The Binding Site range of turbidimetric/nephelometric grade (PN) antisera and The Binding Site MININEPH® range of products.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA, which confirms that a device (Turbidimetric/Nephelometric Human Complement Reference Preparation) is substantially equivalent to a legally marketed predicate device.
While it mentions the device and its indications for use, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets or training sets.
- Information on data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes.
- Whether a standalone algorithm performance study was done.
- The type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for any training set was established.
This document focuses solely on the regulatory clearance based on substantial equivalence, not on the detailed technical studies that would establish specific performance metrics against 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.