# K922565: Neoplastine (R) CI Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Dec 7, 1992 after 189 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 24, 2018 · Class II · Z-2994-2018: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
- Oct 25, 2017 · Class II · Z-1068-2018: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Source page: https://510kreport.com/device/K922565
Methodology: https://510kreport.com/methodology