(49 days)
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of antibodies to Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.
ACCURUN 119 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
human blood based single analyte run control
The provided text is related to a 510(k) premarket notification for a medical device called "ACCURUN™ 119 Anti-Hepatitis B e Antigen (Anti-HBE Positive) Control." This document is an FDA clearance letter from 1997.
Crucially, this document does not contain information about the acceptance criteria, device performance study details, or ground truth establishment that would be required to fill out the table and answer the supplementary questions.
The letter primarily:
- Acknowledges the review of the 510(k) submission.
- Determines substantial equivalence to a predicate device.
- Grants permission to market the device subject to general controls.
- Provides information about CLIA-88, labeling regulations, and other responsibilities.
- Includes the intended use statement for the device.
Therefore, I cannot provide the requested information based on the given input. The information about the study that proves the device meets acceptance criteria, the specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies are typically found in the 510(k) summary or the full 510(k) submission, not in the FDA clearance letter itself.
§ 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.