Cleared Traditional

K924393 - STANDARD HUMAN PLASMA

K924393 is the FDA 510(k) clearance for STANDARD HUMAN PLASMA by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K924393 · Behring Diagnostics, Inc. · Hematology device
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Nov 1992
Decision
77d
Days
Class 2
Risk

K924393 is an FDA 510(k) clearance for the STANDARD HUMAN PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K924393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date November 16, 1992
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K924393.
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · Behring Diagnostics, Inc. · Dec 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · Organon Teknika Corp. · Dec 1992
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
K914188 · Ortho Diagnostic Systems, Inc. · Aug 1992
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
K912087 · Instrumentation Laboratory CO · Sep 1991
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991