# K965116: Abbott Testpack Plus HCG Combo with Obc

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 20, 1997 after 62 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.
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. The FDA summary names its predicate without a number.
- (no number) ABBOTT TestPack® Plus™ hCG COMBO (List No. 3A60): named in the summary without a submission number

## Recalls of this device
- Mar 16, 2005 · Not classified · Z-1392-05: False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.

## Indications for use
The intended use of both assays is the qualitative determination of human chorionic gonadotropin in serum or urine.

Source page: https://510kreport.com/device/K965116
Methodology: https://510kreport.com/methodology