Cleared Traditional

K881037 - SPECTROLYSE/FIBRIN

K881037 is an FDA 510(k) clearance for SPECTROLYSE/FIBRIN, manufactured by Cytrx Biopool, Ltd.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K881037

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.

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 K881037.
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K872479 · American Bioproducts Co. · Aug 1987