# K061257: Dbest HCG Panel Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ameritek USA, Inc.
- Decided: May 4, 2007 after 365 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130456: Wunder Pregnancy Test (2014), 0 descendants of its own

## Indications for use
dBest hCG Panel Test Kit is a simple one step immunochromatographic assay for rapid, semi-quantitative detection of hCG in urine with cutoffs of 25, 100, 500, 2,000 and 1,0,000 mIU/mL. The dBest hCG Panel Test Kits are for professional, physician's offices laboratory and OTC use, for the early detection of pregnancy.

Source page: https://510kreport.com/device/K061257
Methodology: https://510kreport.com/methodology