Cleared Traditional

K912025 - SPECTROLYSE PLASMINOGEN SK KIT

K912025 is an FDA 510(k) clearance for SPECTROLYSE PLASMINOGEN SK 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 107-day FDA review.

K912025 · Biopool AB · Hematology device
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Aug 1991
Decision
107d
Days
Class 2
Risk

K912025 is an FDA 510(k) clearance for the SPECTROLYSE PLASMINOGEN SK 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 August 22, 1991 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Biopool AB devices

FDA 510(k) Submission Details - K912025

510(k) Number K912025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1991
Decision Date August 22, 1991
Days to Decision 107 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
6d faster than avg
Panel avg: 113d · This submission: 107d
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 K912025.
IL TEST PROCLOT ASSAY STYSTEM
K912711 · Instrumentation Laboratory CO · Oct 1991
STACLOT(R) PROTEIN S TEST KIT
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LIATEST PROTEIN S KIT
K912468 · American Bioproducts Co. · Oct 1991
DADE PROTEIN C CLOTTING ASSAY
K903468 · Baxter Healthcare Corp · Feb 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · Helena Laboratories · Jan 1991
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · Helena Laboratories · Mar 1990