# K004034: Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corp.
- Decided: Mar 8, 2001 after 70 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device (2006), 2 descendants of its own
- K071489: Homecheck Multiple Drug Cup Test (2008), 0 descendants of its own
- K061617: Forsure One Step Dip & Read (X) Drug Screen Test (2006), 0 descendants of its own
- K052520: Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K004034
Methodology: https://510kreport.com/methodology