# K222635: Premier Resolution System

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
- Decided: Aug 4, 2023 after 338 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924122 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991127: Variant II B-Thalassemia, Bio-Rad (1999) Summary page 4.

## Indications for use
The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant. The Premier Resolution System is intended for Professional Laboratory Use only. The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech. The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K222635
Methodology: https://510kreport.com/methodology