Cleared Special

K053499 - HEMOSIL PROS

K053499 is an FDA 510(k) clearance for HEMOSIL PROS, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GGP cleared through the Special 510(k) pathway after a 28-day FDA review.

K053499 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
28d
Days
Class 2
Risk

K053499 is an FDA 510(k) clearance for the HEMOSIL PROS. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K053499

510(k) Number K053499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date January 13, 2006
Days to Decision 28 days
Submission Type Special
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
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 183
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K053499.
TRIAGE PROTEIN C TEST
K062530 · Biosite Incorporated · Jan 2007
HEMOSIL PROTEIN C
K062430 · Instrumentation Laboratory CO · Sep 2006
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
K052825 · Affinity Biologicals, Inc. · Jan 2006
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
K050365 · Hyphen Biomed · Dec 2005
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
K050448 · Horiba Abx · Sep 2005
VISULIZE FACTOR IX ANTIGEN KIT
K051054 · Affinity Biologicals, Inc. · Jun 2005
K053499 · HEMOSIL PROS
Download PDF FDA Summary Instrumentation Labor…