Cleared Traditional

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) (K981173) - FDA 510(k) Clearance

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

K981173 · Precision Biologicals, Inc. · Hematology device
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Jan 1999
Decision
287d
Days
Class 2
Risk

K981173 is an FDA 510(k) clearance for the CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.... Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on January 13, 1999 after a review of 287 days - an extended review cycle.

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 Precision Biologicals, Inc. devices

Submission Details

510(k) Number K981173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1998
Decision Date January 13, 1999
Days to Decision 287 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 113d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
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 - GJT Plasma, Coagulation Factor Deficient

All 78
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K981173.
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K034007 · Instrumentation Laboratory CO · Feb 2004