# K030649: Dri Cotinine Eia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 22, 2003 after 83 days
- Product code: MRS (Test System, Nicotine, Cotinine, Metabolites)
- Device class: 1
- Regulation: 21 CFR 862.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972481 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972481: Auto-Lyte Cotinine Eia, OraSure Technologies, Inc. (1997). Our reading of the summary gave K072481, FDA’s number for Jet Port Plus HP Catheter System (Pfm Medical, Inc.), decided Mar 7, 2008, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OTI AUTO-LYTE Cotinine EIA Assay”.

## Indications for use
The DRI@ Cotinine Enzyme Immunoassay is intended for the Qualitative and Semi-Quantitative determination of Cotinine in human urine at a cutoff level of 500 ng/mL. This assay is intended for in vitro diagnostic use only. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products.

Source page: https://510kreport.com/device/K030649
Methodology: https://510kreport.com/methodology