# K903219: Abbott Testpack Plus TM HCG-Combo

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 25, 1990 after 64 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K980736: Acon HCG One Step Urine/Serum Pregnancy Test (1998), 1 descendant of its own
- K072500: One Step HCG Urine/Serum Test (2009), 0 descendants of its own

## Recalls of this device
- Aug 7, 2005 · Not classified · Z-1399-05: False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.

Source page: https://510kreport.com/device/K903219
Methodology: https://510kreport.com/methodology