# K151557: EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine

- Pathway: 510(k) (Traditional)
- Applicant: Nantong Egens Biotech Co., Ltd.
- Decided: Jul 16, 2015 after 36 days
- Product code: DNK (Thin Layer Chromatography, Morphine)
- Device class: 2
- Regulation: 21 CFR 862.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945610 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142580: Chemtrue Multi-Panel DOA DIP Card Tests, Chemtron Biotech, Inc. (2014) Summary page 5.

## Indications for use
The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in.vitro diagnostic use only.-The tests.are intended for over-the-counter.and for. prescription.use.. The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro-diagnostic use-only.-The tests are intended. for. over-the-counter and for.prescription.use. ... .

Source page: https://510kreport.com/device/K151557
Methodology: https://510kreport.com/methodology