510(k) · Cleared
ClearedWondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 21, 2012 as substantially equivalent to K041822 (ACON Laboratories, Inc., 2004) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Dec 21, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033299 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033299 Acon Mamp One Step Methamphetamine Test Strip and Test DeviceACON Laboratories, Inc. · 2003
- This deviceK122961 Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine…Guangzhou Wondfo Biotech Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033299 | Acon Mamp One Step Methamphetamine Test Strip and Test Device | ACON Laboratories, Inc. | 2003 | — |
| 0 (this device) | K122961 | Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test… | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 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 |
|---|---|---|---|
| * | K041822 | Acon Amp 300 One Step Amphetamine Test Strip and DeviceSummary page 1…DKZ 21 CFR, 862.3100 LAF 121 CFR, 862.3610 5. Predicate Devices: 1. K041822 Acon Laboratories, Inc. ACONID AMP 300 One Step Amphetamine Test Strip, ACON® AMP 300 One Step Amphetarmine Test D… | 2004 |
| * | K033299 | Acon Mamp One Step Methamphetamine Test Strip and Test DeviceSummary page 1…icate Devices: 1. K041822 Acon Laboratories, Inc. ACONID AMP 300 One Step Amphetamine Test Strip, ACON® AMP 300 One Step Amphetarmine Test Device 2.1K033299 Acon Laboratories, Inc. ACON® mAMP-500 One Step Methamphetamine Test Strip, ACON® mAMP-5QO One Step Methamphetamin… | 2003 |
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.
- 1 other device also cites its predicate K041822.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Amphetamine Urine Test (AMP 300) is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 300 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. For in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical…
Read the full statement (224 words)
Wondfo Amphetamine Urine Test (AMP 300) is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 300 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. For in vitro diagnostic use only.
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.
Wondfo Methamphetamine Urine Test (MET 500) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 500 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. For in vitro diagnostic use only.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122961: Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122961
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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