Cleared Traditional

K914307 - SPECTROLYSE PROTEIN C KIT

K914307 is an FDA 510(k) clearance for SPECTROLYSE PROTEIN C KIT, manufactured by Biopool AB. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K914307 · Biopool AB · Hematology device
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Dec 1991
Decision
75d
Days
Class 2
Risk

K914307 is an FDA 510(k) clearance for the SPECTROLYSE PROTEIN C KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Biopool AB (Ontario, L7l 6b8, CA). The FDA issued a Cleared decision on December 9, 1991 after a review of 75 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biopool AB devices

FDA 510(k) Submission Details - K914307

510(k) Number K914307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1991
Decision Date December 09, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 113d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 158
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K914307.
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012 · Instrumentation Laboratory CO · Aug 1992
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981 · Medical Diagnostic Technologies, Inc. · Apr 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · Baxter Diagnostics, Inc. · Jan 1992
IL TEST PROCLOT ASSAY STYSTEM
K912711 · Instrumentation Laboratory CO · Oct 1991
STACLOT(R) PROTEIN S TEST KIT
K913424 · American Bioproducts Co. · Oct 1991
LIATEST PROTEIN S KIT
K912468 · American Bioproducts Co. · Oct 1991