Cleared Traditional

K981815 - HEPTRAC ELECTRONIC QUALITY CONTROL

K981815 is an FDA 510(k) clearance for HEPTRAC ELECTRONIC QUALITY CONTROL, manufactured by Medtronic Blood Management. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K981815 · Medtronic Blood Management · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
69d
Days
Class 2
Risk

K981815 is an FDA 510(k) clearance for the HEPTRAC ELECTRONIC QUALITY CONTROL. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Medtronic Blood Management (Parker, US). The FDA issued a Cleared decision on July 30, 1998 after a review of 69 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 Medtronic Blood Management devices

FDA 510(k) Submission Details - K981815

510(k) Number K981815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 30, 1998
Days to Decision 69 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
44d faster than avg
Panel avg: 113d · This submission: 69d
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 149
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K981815.
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998
AVOCET PT
K980839 · Avocet Medical, Inc. · Sep 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · Dade Behring, Inc. · Sep 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · International Technidyne Corp. · Jul 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