Cleared Traditional

K924453 - MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)

K924453 is an FDA 510(k) clearance for MULTI-CHANNEL DISCRETE ANALYZER (MDA-180), manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K924453 · Organon Teknika Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
107d
Days
Class 2
Risk

K924453 is an FDA 510(k) clearance for the MULTI-CHANNEL DISCRETE ANALYZER (MDA-180). Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 18, 1992 after a review of 107 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K924453

510(k) Number K924453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date December 18, 1992
Days to Decision 107 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
6d faster than avg
Panel avg: 113d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K924453.
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
K923761 · International Technidyne Corp. · Jan 1993
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · Behring Diagnostics, Inc. · Dec 1992
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992
STANDARD HUMAN PLASMA
K924393 · Behring Diagnostics, Inc. · Nov 1992
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
K914188 · Ortho Diagnostic Systems, Inc. · Aug 1992