Cleared Traditional

K232027 - CAPI 3 NEONAT Hb

K232027 is the FDA 510(k) clearance for CAPI 3 NEONAT Hb by Sebia. It is a Class 2 Hematology device (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

Submission Details

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.

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 13
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
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · Bio-Rad Laboratories, Inc. · May 2005
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996