Home / 510(k) Clearances / K222635

510(k) K222635

Premier Resolution System by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) — Product Code GKA

K222635 is an FDA 510(k) premarket notification submitted by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) for the device "Premier Resolution System". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2023
Date Received
August 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances for product code GKA

  • K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (April 4, 2024)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (May 25, 2012)
  • K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (May 24, 2012)
  • K091283 — CAPILLARYS NEONAT HB (PN 2006) (February 22, 2010)
  • K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (March 26, 2009)
  • K080911 — VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTE (May 2, 2008)
  • K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (June 27, 2006)

FDA data resources