Cleared Traditional

K911777 - ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED

K911777 is an FDA 510(k) clearance for ROCKET REFERENCE PLASMA, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K911777

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.

GGN Device Classification - Class 2, Special Controls

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 91
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