Cleared Traditional

K222635 - Premier Resolution System (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech) · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
338d
Days
Class 2
Risk

K222635 is an FDA 510(k) clearance for the Premier Resolution System. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (Kansas City, US). The FDA issued a Cleared decision on August 4, 2023 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trinity Biotech (Primus Corporation, Dba Trinity Biotech) devices

Submission Details

510(k) Number K222635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2022
Decision Date August 04, 2023
Days to Decision 338 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 113d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKA Abnormal Hemoglobin Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKA Abnormal Hemoglobin Quantitation

All 22
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K222635.
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
K232027 · Sebia · Apr 2024
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
K192931 · Helena Laboratories, Corp. · Apr 2022
CAPI 3 HEMOGLOBIN(E)
K180762 · Sebia · Dec 2018
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · Bio-Rad Laboratories, Inc. · Sep 2017