Cleared Traditional

K905673 - AB-TROL II COAGULATION CONTROL PLASM CA...

K905673 is the FDA 510(k) clearance for AB-TROL II COAGULATION CONTROL PLASM CA... by Helena Laboratories. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K905673 · Helena Laboratories · Hematology device
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Feb 1991
Decision
55d
Days
Class 2
Risk

K905673 is an FDA 510(k) clearance for the AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 55 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 Helena Laboratories devices

Submission Details

510(k) Number K905673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date February 11, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K905673.
THROMBO-CALIBRATOR KIT
K921344 · American Bioproducts Co. · Jun 1992
COAGULATION ARPR,CAT.NO.5185
K914949 · Helena Laboratories · Mar 1992
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · Helena Laboratories · Aug 1991
COAGULATION CONTROL, LEVEL I
K902361 · Sigma Chemical Co. · Jul 1990
COAGULATION CONTROL, LEVEL II
K902362 · Sigma Chemical Co. · Jul 1990
COAGULATION CONTROL, LEVEL III
K902363 · Sigma Chemical Co. · Jul 1990