(269 days)
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use.
The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.
For In Vitro Diagnostic Use.
The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.
The provided text describes a 510(k) premarket notification for the "Sebia CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument." However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.
The document mainly focuses on:
- The FDA's decision of substantial equivalence.
- The regulatory classification (Class II, Product Code GKA).
- General information about FDA regulations for medical devices.
- The intended use of the device.
Therefore, I cannot provide the specific details about acceptance criteria, performance, sample sizes, ground truth establishment, or expert qualifications as these are not present in the given text.
To answer your request, I would need a different document, typically a Summary of Safety and Effectiveness or a full clinical study report, which is usually part of the 510(k) submission but not contained within this FDA correspondence letter.
§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.