# K002400: Modification of Acl Advance

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 30, 2000 after 26 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 14 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033414: Acl Top Model, Top (2004), 18 descendants of its own
- K063679: Acl Top (2007), 12 descendants of its own
- K073377: Acl Top (with System Software V3.0.0) (2008), 11 descendants of its own
- K091980: Acl Top 700 Las (2009), 7 descendants of its own
- K030965: Control Plasma LMW Heparin (2003), 7 descendants of its own

## Recalls of this device
- May 19, 2005 · Not classified · Z-0915-05: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
- Mar 4, 2004 · Not classified · Z-0737-04: Software may cause instrument to omit step causing reagent carrover which may effect patient test result

Source page: https://510kreport.com/device/K002400
Methodology: https://510kreport.com/methodology