Cleared Traditional

K881037 - SPECTROLYSE/FIBRIN

K881037 is the FDA 510(k) clearance for SPECTROLYSE/FIBRIN by Cytrx Biopool, Ltd.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K881037 · Cytrx Biopool, Ltd. · Hematology device
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Jul 1988
Decision
112d
Days
Class 2
Risk

K881037 is an FDA 510(k) clearance for the SPECTROLYSE/FIBRIN. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Cytrx Biopool, Ltd. (Norcross, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 112 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 Cytrx Biopool, Ltd. devices

Submission Details

510(k) Number K881037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1988
Decision Date July 01, 1988
Days to Decision 112 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 113d · This submission: 112d
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.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K881037.
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