# K052124: Acticlot, Model 824

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Oct 17, 2005 after 73 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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 K940490 (1995). 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)
- K940490: DV Test and DVV Confirm, American Diagnostica, Inc. (1995) Summary page 2.

## Recalls of this device
- Feb 28, 2007 · Not classified · Z-0779-2007: Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

## Indications for use
The ACTICLOT® dPT is intended for the qualitative determination of Lupus Anticoagulants (LA) in human plasma. The test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K052124
Methodology: https://510kreport.com/methodology