Cleared Traditional

SPECTROLYSE ANTIPLASMIN KIT (K941752) - FDA 510(k) Clearance

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

K941752 · Biopool AB · Hematology device
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Sep 1995
Decision
535d
Days
Class 2
Risk

K941752 is an FDA 510(k) clearance for the SPECTROLYSE ANTIPLASMIN 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 September 25, 1995 after a review of 535 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

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Submission Details

510(k) Number K941752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 08, 1994
Decision Date September 25, 1995
Days to Decision 535 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
422d slower than avg
Panel avg: 113d · This submission: 535d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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