# K994194: (Tas) Low Range Heparin Management Card Rapidpoint

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: Mar 28, 2000 after 106 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- 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) Low Range Activated Clotting Time test (ACT-LR), performed on the Hemochron Jr.: named in the summary without a submission number
- (no number) Activated Clotting Time test (ACT), performed on the Hemochron: named in the summary without a submission number

## Indications for use
The Rapidpoint Coag Low range Heparin Management Test Card is to be used with the Rapidpoint Coag Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures. The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin.

Source page: https://510kreport.com/device/K994194
Methodology: https://510kreport.com/methodology