Cleared Traditional

K911777 - ROCKET REFERENCE PLASMA

K911777 is the FDA 510(k) clearance for ROCKET REFERENCE PLASMA by Helena Laboratories. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K911777 · Helena Laboratories · Hematology device
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Aug 1991
Decision
142d
Days
Class 2
Risk

K911777 is an FDA 510(k) clearance for the ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED. 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 August 22, 1991 after a review of 142 days - within the typical 510(k) review window.

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 Helena Laboratories devices

Submission Details

510(k) Number K911777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1991
Decision Date August 22, 1991
Days to Decision 142 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
29d slower than avg
Panel avg: 113d · This submission: 142d
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 K911777.
COAG-CONTROL [N] KIT
K922174 · American Bioproducts Co. · Oct 1992
THROMBO-CALIBRATOR KIT
K921344 · American Bioproducts Co. · Jun 1992
COAGULATION ARPR,CAT.NO.5185
K914949 · Helena Laboratories · Mar 1992
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
K905673 · Helena Laboratories · Feb 1991
COAGULATION CONTROL, LEVEL I
K902361 · Sigma Chemical Co. · Jul 1990
COAGULATION CONTROL, LEVEL II
K902362 · Sigma Chemical Co. · Jul 1990