Cleared Traditional

K945856 - POSITIVE LUPUS ANTICOAGULANT PLASMA (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.