# K121987: Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Aug 1, 2012 after 26 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K020771 (2002). 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)
- K020771: Acon One Step Drug Screen Test Card, ACON Laboratories, Inc. (2002) Summary page 1.

## Indications for use
Wondfo Amphetamine Urine Test is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of lOOOng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical mnethod must be used in order to obtain a conformed analytical result. GCIMS 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. Wondfo Secobarbital Urine Test is an immunochromatographic assay for the qualitative determination of Secobarbital (major metabolite of Barbiturates) in human urine at a cutoff concentration of 300ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCIMS 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. Wondfo Oxazepam Urine Test is an immunochromatographic assay for the qualitative determination of Oxazepam (major metabolite of Benzodiazepines) in human urine at a cutoff concentration of 300ng~mL. The test is available in a dip card format and a cup format It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCJMS is the preferred confirmatory method. Clinical consideration and professionaI judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Source page: https://510kreport.com/device/K121987
Methodology: https://510kreport.com/methodology