510(k) · Cleared
ClearedWondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · LAF Gas Chromatography, Methamphetamine
Cleared on Sep 19, 2011 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 19, 2011
- Review
- 46 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K020771 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- This deviceK112236 Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine…Guangzhou Wondfo Biotech Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020771 | Acon One Step Drug Screen Test Card | ACON Laboratories, Inc. | 2002 | — |
| 0 (this device) | K112236 | Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020771 | Acon One Step Drug Screen Test CardSummary page 1…21CFR862.3850 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: 1). Avon Laboratories, Inc., ACONO One Step Drug Screen Test, K020771. 2). Acon Laboratories, Inc., AconO MDMA One Step Ecstasy Test, K022589 5. Description of the device: Assay Pri… | 2002 |
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceSummary page 1…e [807.92(a)(3)]: 1). Avon Laboratories, Inc., ACONO One Step Drug Screen Test, K020771. 2). Acon Laboratories, Inc., AconO MDMA One Step Ecstasy Test, K022589 5. Description of the device: Assay Principle: lmmunochromatograph assay for Methylenedioxymethamphetamine and M… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K020771.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Methylenedioxymethamphetamine Urine Test Is an immunochromatographic assay for the qualitative determination of MDMA In human urine at a cutoff concentration of 500ng/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 resultL…
Read the full statement (198 words)
Wondfo Methylenedioxymethamphetamine Urine Test Is an immunochromatographic assay for the qualitative determination of MDMA In human urine at a cutoff concentration of 500ng/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 resultL 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.
Wondfo Morphine Urine Test is an immunochromatographic assay for the qualitative determination of Morphine 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 resultL 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112236: Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112236
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026