# K870521: Tandem (R) M-Pak (TM) Total B-HCG Immunoenzy. Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hybritech, Inc.
- Decided: Apr 8, 1987 after 61 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2083-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Source page: https://510kreport.com/device/K870521
Methodology: https://510kreport.com/methodology