# K972831: Hemochron Citrate Aptt

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Nov 20, 1997 after 113 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K014008: Hemochron JR. Citrate Aptt Cuvette (2002), 0 descendants of its own

## Indications for use
The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.

Source page: https://510kreport.com/device/K972831
Methodology: https://510kreport.com/methodology