# K981815: Heptrac Electronic Quality Control

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Blood Management
- Decided: Jul 30, 1998 after 69 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACTtrac: named in the summary without a submission number

## Indications for use
The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.

Source page: https://510kreport.com/device/K981815
Methodology: https://510kreport.com/methodology