Cleared Traditional

K222831 - CRYOcheck Factor VIII Deficient Plasma ...

K222831 is an FDA 510(k) clearance for CRYOcheck Factor VIII Deficient Plasma ..., manufactured by Precision Biologic, Inc.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K222831 · Precision Biologic, Inc. · Hematology device
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Sep 2023
Decision
359d
Days
Class 2
Risk

K222831 is an FDA 510(k) clearance for the CRYOcheck Factor VIII Deficient Plasma with VWF. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Precision Biologic, Inc. (Darmouth, CA). The FDA issued a Cleared decision on September 13, 2023 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biologic, Inc. devices

FDA 510(k) Submission Details - K222831

510(k) Number K222831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2022
Decision Date September 13, 2023
Days to Decision 359 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
246d slower than avg
Panel avg: 113d · This submission: 359d
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 62
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K222831.
HemosIL Factor XII Deficient Plasma
K180486 · Instrumentation Laboratory CO · Mar 2018
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · Instrumentation Laboratory CO · Jul 2011
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · Instrumentation Laboratory CO · May 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · Instrumentation Laboratory CO · Feb 2005
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · Instrumentation Laboratory CO · Feb 2004
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · Instrumentation Laboratory CO · Jul 2003