# K002331: Profile-ER

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jan 17, 2001 after 169 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (2023), 1 descendant of its own
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own
- K221550: Evidence MultiSTAT DOA Urine MultiPlex (2023), 0 descendants of its own
- K100023: Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K002331
Methodology: https://510kreport.com/methodology