Cleared Traditional

K914188 - KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM

K914188 is an FDA 510(k) clearance for KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K914188 · Ortho Diagnostic Systems, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Aug 1992
Decision
343d
Days
Class 2
Risk

K914188 is an FDA 510(k) clearance for the KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 343 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K914188

510(k) Number K914188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date August 26, 1992
Days to Decision 343 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
230d slower than avg
Panel avg: 113d · This submission: 343d
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 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K914188.
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · Organon Teknika Corp. · Dec 1992
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992
STANDARD HUMAN PLASMA
K924393 · Behring Diagnostics, Inc. · Nov 1992
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
K912087 · Instrumentation Laboratory CO · Sep 1991
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
ACS 0.02 M CALCIUM CHLORIDE
K902458 · Analytical Control Systems, Inc. · Aug 1990