(21 days)
The ß2-microglobulin Control Set Serum is used for the quality control of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.
The ß2-microglobulin Control Set Serum is used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.
The Boehringer Mannheim ß2-microglobulin Control Set Serum is manufactured using human serum albumin, ß2-microglobulin, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
The provided text is a 510(k) summary for a medical device called "β2-microglobulin Control Set Serum." This document is primarily focused on establishing substantial equivalence of a new control set to an existing one for quality control in laboratory assays. It does not contain information about acceptance criteria for a device's performance in a clinical study, nor does it describe a study that proves the device meets such criteria.
Specifically, the document focuses on:
- Device identification: Naming the device and its intended use (quality control of a specific assay).
- Predicate device comparison: Comparing the new control set to an existing one (Abbott Imx β2-microglobulin assay controls) to demonstrate substantial equivalence based on similarities (intended use, same analyte) and minor differences (control levels, matrix, preparation).
- Regulatory information: Such as the submitter's name, contact, date prepared, and the FDA's clearance letter.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone algorithm performance) from the provided text. The document describes a control product used for quality assurance, not a diagnostic or therapeutic device whose performance would be assessed against clinical acceptance criteria in the manner you've outlined.
§ 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.