Cleared Traditional

K974343 - DADE INNOVIN

K974343 is the FDA 510(k) clearance for DADE INNOVIN by Dade Intl., Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K974343 · Dade Intl., Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
245d
Days
Class 2
Risk

K974343 is an FDA 510(k) clearance for the DADE INNOVIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on July 22, 1998 after a review of 245 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 Dade Intl., Inc. devices

Submission Details

510(k) Number K974343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date July 22, 1998
Days to Decision 245 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
132d slower than avg
Panel avg: 113d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K974343.
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
K992492 · Roche Diagnostics Corp. · Nov 1999
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
K972866 · International Technidyne Corp. · Sep 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998
MDA SIMPLASTIN HTF
K974566 · Organon Teknika Corp. · Feb 1998
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · Sigma Diagnostics, Inc. · Oct 1997