510(k) · Cleared
ClearedSAFECARE® THC Urine Strip Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safecare Biotech (Hangzhou) Co., Ltd. · NFW Test, Cannabinoid, Over The Counter
Cleared on Aug 16, 2019 as substantially equivalent to K153646 (Safecare Biotech (Hangzhou) Co., Ltd., 2016) after a 29-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Aug 16, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- NFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K050186 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- 2 generations backK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- 1 generation backK153646 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine…Safecare Biotech (Hangzhou) Co., Ltd. · 2016
- This deviceK191924 SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| −2 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| −1 | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine… | Safecare Biotech (Hangzhou) Co., Ltd. | 2016 | — |
| 0 (this device) | K191924 | SAFECARE® THC Urine Strip Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2019 | — |
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 NFW? 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 NFW device
- #1 K252523 Healgen® Accurate Oral Fluid Drug Test…score 12.0 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…Summary page 4…# Panel Code NFW 21 CFR, 862.3870 Cannabinoid Test System Toxicology 5. Predicate Devices: K153646 SAFECARE Urine Test Marijuana 6. Intended Use SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immuno… | 2016 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All NFW devicesNFW Test, Cannabinoid, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NFW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NFW
Too few NFW 510(k)s in any year since 2007 to give a median.
Recalls per year · NFW
No recall names NFW since 2007.
Adverse event reports per year · NFW
1in 2025
MAUDE reports naming product code NFW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative
detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
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 or LC/MS is the preferred confirmatory method.
The test is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191924: SAFECARE® THC Urine Strip Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191924
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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