# K992851: Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 14, 2000 after 143 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
Longest line of descent: 1 generation back to K832189 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832189: Hemochron Thrombochronometer, International Technidyne Corp. (1983) Summary page 1.
- K913861: Hemochron (R) Kact, International Technidyne Corp. (1991) Summary page 1.
- K960749: Hemochron JR. Microcoagulation Low Range Act, International Technidyne Corp. (1996) Summary page 1.

## Indications for use
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

Source page: https://510kreport.com/device/K992851
Methodology: https://510kreport.com/methodology