Cleared Traditional

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (K112491) - FDA 510(k) Clearance

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

K112491 · Sebia · Hematology device
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May 2012
Decision
269d
Days
Class 2
Risk

K112491 is an FDA 510(k) clearance for the SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Sebia (Evry, FR). The FDA issued a Cleared decision on May 24, 2012 after a review of 269 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 K112491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date May 24, 2012
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 113d · This submission: 269d
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 K112491.
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K180762 · Sebia · Dec 2018
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K171664 · Bio-Rad Laboratories, Inc. · Sep 2017