Cleared Traditional

K091283 - CAPILLARYS NEONAT HB (PN 2006)

K091283 is an FDA 510(k) clearance for CAPILLARYS NEONAT HB (PN 2006), manufactured by Sebia. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K091283 · Sebia · Hematology device
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Feb 2010
Decision
297d
Days
Class 2
Risk

K091283 is an FDA 510(k) clearance for the CAPILLARYS NEONAT HB (PN 2006). Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 297 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.

FDA 510(k) Submission Details - K091283

510(k) Number K091283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2009
Decision Date February 22, 2010
Days to Decision 297 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 113d · This submission: 297d
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 22
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K091283.
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
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · Sebia · Mar 2009
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
K080911 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · May 2008
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · Sebia · Jun 2006
K091283 · CAPILLARYS NEONAT HB (PN 2006)
Download PDF Sebia