Premier Resolution System
FDA 510(k) K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
510(k) numberK222635
Submission
- Device name
- Premier Resolution System
- Applicant
- Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
Kansas City, MO, US - Received
- August 31, 2022
- Decision date
- August 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
Other 510(k)s with product code GKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | Sebia | 04/04/2024SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | Helena Laboratories, Corp. | 04/19/2022SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | Sebia | 12/14/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | Bio-Rad Laboratories, Inc. | 09/13/2017SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | Sebia | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | Sebia | 05/24/2012SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | Sebia | 02/22/2010SE |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | Sebia | 03/26/2009SE |
| K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…GKA · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 05/02/2008SE |
| K052291 | Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional | Sebia | 06/27/2006SE |
Questions and answers
When was Premier Resolution System cleared by the FDA?
Premier Resolution System (K222635) received a 510(k) decision of Substantially Equivalent on August 4, 2023, 338 days after the submission was received.
What is the product code of K222635?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.