Cleared Traditional

K050709 - RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 (FDA 510(k) Clearance)

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

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.

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Submission Details

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
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.

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.