510(k) · Cleared
ClearedSAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · NGL Test, Opiates, Over The Counter
Cleared on Jul 16, 2024 as substantially equivalent to K233417 (Hangzhou AllTest Biotech Co., Ltd., 2023) after a 29-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jul 16, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001178 (2000). 9 ancestors in all, the oldest K973547 (1998). No later device cites it as a predicate yet.
- Root · 8 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 7 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 6 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 5 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 4 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 3 generations backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- 2 generations backK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- This deviceK241741 SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl…Guangzhou Wondfo Biotech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −7 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −6 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −5 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −4 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −3 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| −2 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −1 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| 0 (this device) | K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 NGL? 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 NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K233417 | AllTest Fentanyl Urine Test CassetteSummary page 5…FR § 862.3650 Toxicology (91) Opiate Test System 5. Predicate Devices: AllTest Fentanyl Urine Test Cassette (K233417) 6. Indications for Use The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochr… | 2023 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- 7 other devices also cite its predicate K233417.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or…
Read the full statement (369 words)
The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241741: SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241741
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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