Cleared Traditional

SPECTROLYSE HEPARIN KIT (K923499) - FDA 510(k) Clearance

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

K923499 · Biopool AB · Hematology device
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Jan 1994
Decision
561d
Days
Class 2
Risk

K923499 is an FDA 510(k) clearance for the SPECTROLYSE HEPARIN KIT. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Biopool AB (Ontario, L7l 6b8, CA). The FDA issued a Cleared decision on January 27, 1994 after a review of 561 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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.

View all Biopool AB devices

Submission Details

510(k) Number K923499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date January 27, 1994
Days to Decision 561 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
448d slower than avg
Panel avg: 113d · This submission: 561d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 45
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K923499.
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HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
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COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994