Cleared Traditional

K971219 - CRYO CHECK INR VALIDATION SET

K971219 is an FDA 510(k) clearance for CRYO CHECK INR VALIDATION SET, manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K971219 · Precision Biologicals, Inc. · Hematology device
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Aug 1997
Decision
149d
Days
Class 2
Risk

K971219 is an FDA 510(k) clearance for the CRYO CHECK INR VALIDATION SET. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on August 29, 1997 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 - K971219

510(k) Number K971219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date August 29, 1997
Days to Decision 149 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
36d slower than avg
Panel avg: 113d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K971219.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
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THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
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AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982 · Avocet Medical, Inc. · Apr 1998
CRYO CHECK APC RESISTANT PLASMA
K971222 · Precision Biologicals, Inc. · Aug 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co. · Jun 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · Pacific Hemostasis · Jun 1997