Cleared Traditional

K941872 - SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302

K941872 is the FDA 510(k) clearance for SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 by Helena Laboratories. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K941872 · Helena Laboratories · Hematology device
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Nov 1994
Decision
217d
Days
Class 2
Risk

K941872 is an FDA 510(k) clearance for the SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 217 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 Helena Laboratories devices

Submission Details

510(k) Number K941872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date November 21, 1994
Days to Decision 217 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 113d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K941872.
LA POSITIVE CONTROL PLASMA
K961370 · Medical Diagnostic Technologies, Inc. · May 1996
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
STA-COAG CONTROL [P] PLUS KIT
K952338 · American Bioproducts Co. · Sep 1995
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267 · Biomerieux Vitek, Inc. · Mar 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · Behring Diagnostics, Inc. · Feb 1994
CONTROL PLASMA U
K924402 · Behring Diagnostics, Inc. · Feb 1994