Cleared Traditional

K050709 - RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

K050709 is an FDA 510(k) clearance for RESOLVE HEMOGLOBIN KIT, manufactured by Wallac OY. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K050709 · Wallac OY · Hematology device
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Mar 2006
Decision
355d
Days
Class 2
Risk

K050709 is an FDA 510(k) clearance for the RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-936.... Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on March 8, 2006 after a review of 355 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 Wallac OY devices

FDA 510(k) Submission Details - K050709

510(k) Number K050709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date March 08, 2006
Days to Decision 355 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
242d slower than avg
Panel avg: 113d · This submission: 355d
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 K050709.
CAPILLARYS NEONAT HB (PN 2006)
K091283 · Sebia · Feb 2010
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · Sebia · Mar 2009
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · Sebia · Jun 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
PRIMUS VARIANT SYSTEM PVS99
K955283 · Primus Corp. · Mar 1996