510(k) · Cleared
ClearedWondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Cleared on Sep 9, 2011 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 9, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- LFG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980249 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK980249 Accusign Tca, Biosign Tca, Staus DS TcaPrinceton BioMeditech Corp. · 1998
- 1 generation backK021526 Acon Tca One Step Tricyclic Antidepressant Test Strip and DeviceACON Laboratories, Inc. · 2002
- This deviceK112395 Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980249 | Accusign Tca, Biosign Tca, Staus DS Tca | Princeton BioMeditech Corp. | 1998 | — |
| −1 | K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and Device | ACON Laboratories, Inc. | 2002 | — |
| 0 (this device) | K112395 | Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants 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 LFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…CFR 862.3910 4. The legally marketed devices to which we are claiming equivalence [807.92(a)(3)): 1). Acon Laboratories, Inc., ACONS One Step Drug Screen Test, K020771. 2). Acon Laboratories, Inc., Acon® TCA One Step Tricyclic Antidepressant Test, K021526 5. Description of the device:… | 2002 |
| * | K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and DeviceSummary page 1…: 1). Acon Laboratories, Inc., ACONS One Step Drug Screen Test, K020771. 2). Acon Laboratories, Inc., Acon® TCA One Step Tricyclic Antidepressant Test, K021526 5. Description of the device: Assay Principle: lmmunochromatograph assay for Phencyclidine and Notriptyline Urine… | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
- 8 other devices also cite its predicate K020771.
How does its category compare?
All LFG devicesLFG Radioimmunoassay, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LFG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFG
Too few LFG 510(k)s in any year since 2007 to give a median.
Recalls per year · LFG
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFG
1in 2024
MAUDE reports naming product code LFG, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 2Sng/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…
Read the full statement (237 words)
Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 2Sng/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 Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 nglmL. 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 tests will yield preliminary positive results when the prescription drug Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Nortriptyline in urine.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or HPLC 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/K112395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112395: Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants 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/K112395
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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