Cleared Traditional

K232027 - CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

K232027 is an FDA 510(k) clearance for CAPI 3 NEONAT Hb, manufactured by Sebia. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K232027 · Sebia · Hematology device
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Apr 2024
Decision
272d
Days
Class 2
Risk

K232027 is an FDA 510(k) clearance for the CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on April 4, 2024 after a review of 272 days - an extended review cycle.

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. Standard predicate reliance. 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 Sebia devices

FDA 510(k) Submission Details - K232027

510(k) Number K232027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date April 04, 2024
Days to Decision 272 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
159d slower than avg
Panel avg: 113d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKA Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K232027.
Premier Resolution System
K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech) · Aug 2023
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
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
K112550 · Sebia · May 2012
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
K112491 · Sebia · May 2012