# K992492: PTN Test Cartridges for Coaguchek Pro System, PTN Controls for Coaguchek Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 2, 1999 after 99 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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) Roche Diagnostics PT Test and Controls for the CoaguChek System: named in the summary without a submission number

## Indications for use
The CoaguChek Pro PT™ test cartridge is for the quantitative determination of the prothrombin 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/K992492
Methodology: https://510kreport.com/methodology