(113 days)
Boston Biomedica intends to manufacture and market ACCURUN 120 HAV IgG Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits.
This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to HAV in human serum and plasma.
ACCURUN 120 HAV IgG Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV).
The provided text is a 510(k) clearance letter from the FDA for a device named "ACCURUN™ 120 HAV IgG Positive Control". This document grants market clearance based on substantial equivalence to a predicate device. It explicitly states that the device is a "human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV)".
This document is a regulatory approval letter and does not contain the detailed study data, acceptance criteria, or performance metrics that would typically be found in a study report or scientific publication.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present within the provided text.
Based on the information available, I can only state the following:
- Device Name: ACCURUN™ 120 HAV IgG Positive Control
- Intended Use: A human blood-based single analyte run control for use with in vitro diagnostic tests for the detection of IgG antibodies to HAV in human serum and plasma. It is not intended as a substitute for controls provided with test kits.
- Regulatory Status: Cleared by the FDA as substantially equivalent (K971406/S1).
- Date of Clearance: August 7, 1997.
§ 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.