Cleared Traditional

K971226 - CRYO CHECK FACTOR IX DEFICIENT PLASMA

K971226 is the FDA 510(k) clearance for CRYO CHECK FACTOR IX DEFICIENT PLASMA by Precision Biologicals, Inc.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K971226 · Precision Biologicals, Inc. · Hematology device
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Jul 1997
Decision
107d
Days
Class 2
Risk

K971226 is an FDA 510(k) clearance for the CRYO CHECK FACTOR IX DEFICIENT PLASMA. 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 July 18, 1997 after a review of 107 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 Precision Biologicals, Inc. devices

Submission Details

510(k) Number K971226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date July 18, 1997
Days to Decision 107 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
6d faster than avg
Panel avg: 113d · This submission: 107d
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 61
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K971226.
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STA - LIATEST VWF TEST KIT
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K962671 · American Bioproducts Co. · Sep 1996
BIOMERIEUX HEMOLAB COFAC II
K942049 · Biomerieux Vitek, Inc. · May 1995