Cleared Traditional

K052291 - CAPILLARY'S HEMOGLOBIN(E) (PN 2007)

K052291 is an FDA 510(k) clearance for CAPILLARY'S HEMOGLOBIN(E) (PN 2007), manufactured by Sebia. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K052291 · Sebia · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
308d
Days
Class 2
Risk

K052291 is an FDA 510(k) clearance for the CAPILLARY'S HEMOGLOBIN(E) (PN 2007). Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 308 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 Sebia devices

FDA 510(k) Submission Details - K052291

510(k) Number K052291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2005
Decision Date June 27, 2006
Days to Decision 308 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
195d slower than avg
Panel avg: 113d · This submission: 308d
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 K052291.
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
K112491 · Sebia · May 2012
CAPILLARYS NEONAT HB (PN 2006)
K091283 · Sebia · Feb 2010
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · Sebia · Mar 2009
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
K050709 · Wallac OY · Mar 2006
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · Bio-Rad Laboratories, Inc. · May 2005
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996