Cleared Traditional

K952338 - STA-COAG CONTROL [P] PLUS KIT

K952338 is an FDA 510(k) clearance for STA-COAG CONTROL [P] PLUS KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K952338 · American Bioproducts Co. · Hematology device
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Sep 1995
Decision
125d
Days
Class 2
Risk

K952338 is an FDA 510(k) clearance for the STA-COAG CONTROL [P] PLUS KIT. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 125 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K952338

510(k) Number K952338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1995
Decision Date September 21, 1995
Days to Decision 125 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
12d slower than avg
Panel avg: 113d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGC Device Classification - Class 2, Special Controls

Product Code GGC Control, Plasma, Abnormal
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 - GGC Control, Plasma, Abnormal

All 36
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K952338.
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
CRYO CHECK LUPUS PLASMA
K952623 · Precision Biologicals, Inc. · Nov 1995
CRYO CHECK ABNORMAL REFERENCE CHECK I & II
K952624 · Precision Biologicals, Inc. · Oct 1995
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267 · Biomerieux Vitek, Inc. · Mar 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · Behring Diagnostics, Inc. · Feb 1994