# K142609: CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Dec 18, 2014 after 93 days
- Product code: LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs)
- Device class: 2
- Regulation: 21 CFR 862.3910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K091588 (2009). 4 ancestors in all.
1 later device descends 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)
- K132812: Ucp Multi-Drug Test Key Cups, Ucp Biosciences, Inc. (2014) 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 Nortriptyline—-Buprenorphine is a rapid test for the qualitative detection of Nortriptyline (a major metabolite of Tricyclic Antidepressants) and Buprenorphine in human urine at a cutoff concentration of 1000ng/mL and 10ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use. The test may yield preliminary positive results even when prescription drugs including Tricyclic Antidepressants and Buprenorphine are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Nortriptyline and Buprenorphine 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. 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.

Source page: https://510kreport.com/device/K142609
Methodology: https://510kreport.com/methodology