Cleared Traditional

K974799 - HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE

K974799 is an FDA 510(k) clearance for HEMOCHRON JR GENERATION II, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K974799 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
197d
Days
Class 2
Risk

K974799 is an FDA 510(k) clearance for the HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 197 days - an extended review 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: 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K974799

510(k) Number K974799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date July 07, 1998
Days to Decision 197 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
84d slower than avg
Panel avg: 113d · This submission: 197d
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 145
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K974799.
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · International Technidyne Corp. · Apr 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · Dade Behring, Inc. · Sep 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · Sigma Diagnostics, Inc. · Oct 1997
BEHRING COAGULATION SYSTEM
K970431 · Behring Diagnostics, Inc. · May 1997