Cleared Traditional

K952623 - CRYO CHECK LUPUS PLASMA

K952623 is an FDA 510(k) clearance for CRYO CHECK LUPUS PLASMA, manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K952623 · Precision Biologicals, Inc. · Hematology device
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Nov 1995
Decision
151d
Days
Class 2
Risk

K952623 is an FDA 510(k) clearance for the CRYO CHECK LUPUS PLASMA. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on November 6, 1995 after a review of 151 days - an extended review cycle.

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 - K952623

510(k) Number K952623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1995
Decision Date November 06, 1995
Days to Decision 151 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
38d slower than avg
Panel avg: 113d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGC Device Classification - Class 2, Special Controls

Product Code GGC Control, Plasma, Abnormal
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 - GGC Control, Plasma, Abnormal

All 36
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K952623.
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · Pacific Hemostasis · Dec 1998
LA POSITIVE CONTROL PLASMA
K961370 · Medical Diagnostic Technologies, Inc. · May 1996
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
CRYO CHECK ABNORMAL REFERENCE CHECK I & II
K952624 · Precision Biologicals, Inc. · Oct 1995
STA-COAG CONTROL [P] PLUS KIT
K952338 · American Bioproducts Co. · Sep 1995
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994