Cleared Traditional

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

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

K943518 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
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

Submission Details

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.

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 K943518.
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996
PORCINE FACTOR VIII
K952321 · Helena Laboratories · Mar 1996
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