Cleared Traditional

K943518 - STA SYSTEM CONTROL [N] + [P] KIT

K943518 is an FDA 510(k) clearance for STA SYSTEM CONTROL [N] + [P] KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K943518 · American Bioproducts Co. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
243d
Days
Class 2
Risk

K943518 is an FDA 510(k) clearance for the STA SYSTEM CONTROL [N] + [P] KIT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 243 days - an extended review 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: 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K943518

510(k) Number K943518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date March 21, 1995
Days to Decision 243 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 113d · This submission: 243d
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 K943518.
CRYO CHECK LOW FIBRINOGEN CONTROL
K951823 · Precision Biologicals, Inc. · Jan 1996
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
K952622 · Precision Biologicals, Inc. · Oct 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209 · Ortho Diagnostic Systems, Inc. · May 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · International Technidyne Corp. · Mar 1995
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · Helena Laboratories · Sep 1994
COAGULATION A.R.P.
K933277 · Helena Laboratories · Mar 1994