Cleared Traditional

K945856 - POSITIVE LUPUS ANTICOAGULANT PLASMA

K945856 is the FDA 510(k) clearance for POSITIVE LUPUS ANTICOAGULANT PLASMA by George King Bio-Medical, Inc.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K945856 · George King Bio-Medical, Inc. · Hematology device
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Oct 1995
Decision
325d
Days
Class 2
Risk

K945856 is an FDA 510(k) clearance for the POSITIVE LUPUS ANTICOAGULANT PLASMA. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 George King Bio-Medical, Inc. devices

Submission Details

510(k) Number K945856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date October 05, 1995
Days to Decision 325 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
212d slower than avg
Panel avg: 113d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K945856.
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · Sigma Diagnostics, Inc. · Mar 2001
LA POSITIVE CONTROL PLASMA
K961370 · Medical Diagnostic Technologies, Inc. · May 1996
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
STA-COAG CONTROL [P] PLUS KIT
K952338 · American Bioproducts Co. · Sep 1995
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · Behring Diagnostics, Inc. · Feb 1994