Cleared Traditional

CONTROL PLASMA P (K924405) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924405 · Behring Diagnostics, Inc. · Hematology device
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Dec 1992
Decision
92d
Days
Class 2
Risk

K924405 is an FDA 510(k) clearance for the CONTROL PLASMA P. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 92 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K924405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date December 01, 1992
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
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 39
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K924405.
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
SPECIALTY ASSAYED CONTROL-2
K100103 · Helena Laboratories · Dec 2010
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · Baxter Healthcare Corp · Jun 1991