# K014008: Hemochron JR. Citrate Aptt Cuvette

- Pathway: 510(k) (Special)
- Applicant: Itc, Inc.
- Decided: Jan 24, 2002 after 50 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K972831 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972831: Hemochron Citrate Aptt, International Technidyne Corp. (1997) Summary page 1.

## Recalls of this device
- Dec 19, 2013 · Class II · Z-0937-2014: ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

## Indications for use
The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K014008
Methodology: https://510kreport.com/methodology