# K983892: Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
- Decided: Apr 13, 1999 after 161 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860720 (1986). 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)
- K860720: Biotrack Monitor (Biotrack Reagent Cartridges), Biotrack, Inc. (1986) Summary page 1.
- K890052: Biotrack Aptt Reagent Cartridge, Biotrack, Inc. (1989) Summary page 1.
- K890051: Biotrack Aptt Controls, Biotrack, Inc. (1989) Summary page 1.

## Recalls of this device
- Mar 12, 2003 · Not classified · Z-0813-03: High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

## Indications for use
The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.

Source page: https://510kreport.com/device/K983892
Methodology: https://510kreport.com/methodology