Cleared Traditional

AVK CONTROL I & II (K921665) - FDA 510(k) Clearance

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

K921665 · American Bioproducts Co. · Hematology device
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Jun 1992
Decision
63d
Days
Class 2
Risk

K921665 is an FDA 510(k) clearance for the AVK CONTROL I & II. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K921665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1992
Decision Date June 09, 1992
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
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 39
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K921665.
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
SPECIALTY ASSAYED CONTROL-2
K100103 · Helena Laboratories · Dec 2010
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · Baxter Healthcare Corp · Jun 1991