Cleared Traditional

K971226 - CRYO CHECK FACTOR IX DEFICIENT PLASMA

K971226 is an FDA 510(k) clearance for CRYO CHECK FACTOR IX DEFICIENT PLASMA, manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K971226

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
Combination Product No
PCCP Authorized No
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.

GJT Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K971226.
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · Dade Behring, Inc. · Oct 1998
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
K972627 · Pacific Hemostasis · Aug 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · Precision Biologicals, Inc. · Jul 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · Precision Biologicals, Inc. · Jul 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · Precision Biologicals, Inc. · Jul 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · Precision Biologicals, Inc. · Jul 1997