# K143535: CR3 Keyless Split Sample Cup Secobarbital- Methadone

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jan 13, 2015 after 29 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
Longest line of descent: 1 generation back to K122904 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122904: Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;, Guangzhou Wondfo Biotech Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K151478: Wondfo CR3 Keyless Split Sample Cup (2015), 0 descendants of its own

## Indications for use
CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs. The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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

Source page: https://510kreport.com/device/K143535
Methodology: https://510kreport.com/methodology