# K994219: AT Home Drug Test, Model 9073

- Pathway: 510(k) (Special)
- Applicant: Phamatech
- Decided: Dec 30, 1999 after 15 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- 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) QuickScreen At Home Drug Test: named in the summary without a submission number
- (no number) Applied Biotech SureStep Test: named in the summary without a submission number

## Indications for use
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Cocaine (benzoylecgonine).

Source page: https://510kreport.com/device/K994219
Methodology: https://510kreport.com/methodology