Cleared Traditional

K924402 - CONTROL PLASMA U

K924402 is the FDA 510(k) clearance for CONTROL PLASMA U by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 540-day FDA review.

K924402 · Behring Diagnostics, Inc. · Hematology device
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Feb 1994
Decision
540d
Days
Class 2
Risk

K924402 is an FDA 510(k) clearance for the CONTROL PLASMA U. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K924402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date February 22, 1994
Days to Decision 540 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
427d slower than avg
Panel avg: 113d · This submission: 540d
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 K924402.
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
FACTOR CONTROL [P]
K930959 · American Bioproducts Co. · May 1993
COAG-CONTROL
K930923 · American Bioproducts Co. · Apr 1993
CONTROL PLASMA P
K924405 · Behring Diagnostics, Inc. · Dec 1992