510(k) · Cleared
ClearedSAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safecare Biotech (Hangzhou) Co., Ltd. · NFT Test, Amphetamine, Over The Counter
Cleared on May 27, 2020 as substantially equivalent to K182654 (Safecare Biotech (Hangzhou) Co., Ltd., 2018) after a 30-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- May 27, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945610 (1995). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 5 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 4 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 3 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 2 generations backK142396 Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip…Chemtron Biotech, Inc. · 2014
- 1 generation backK182654 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2018
- This deviceK201120 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK202453 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −6 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −5 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −4 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −3 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −2 | K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | Chemtron Biotech, Inc. | 2014 | — |
| −1 | K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2018 | — |
| 0 (this device) | K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2020 | — |
| +1 | K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 NFT? 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 NFT device
- #1 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest…score 20.3 · 9 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 |
|---|---|---|---|
| * | K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardSummary page 6…(91) 3, 3-diphenylpyrrolidine 5. Predicate Device The SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup (K182654) 6. Intended Use SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic as… | 2018 |
| † | K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | 2018 |
| † | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | 2021 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K202453 (Safecare Biotech (Hangzhou) Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NFT devicesNFT Test, Amphetamine, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NFT
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFT
37in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFT
No recall names NFT since 2007.
Adverse event reports per year · NFT
No MAUDE report names NFT 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 | 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 | 1 | — | 0 | 0 |
| 2018 | 6 | 56 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 63 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 4 | 31 | 0 | 0 |
| 2025 | 8 | 37 | 0 | 0 |
| 2026 | 5 | 35 | 0 | — |
What is it indicated for?
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations…
Read the full statement (426 words)
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Amphetamine 1000 ng/mL
Oxazepam 300 ng/mL
Cocaine 300 ng/mL
Marijuana 50 ng/mL
Methamphetamine 1000 ng/mL
Morphine 2000 ng/mL
Oxycodone 100 ng/mL
Secobarbital 300 ng/mL
Buprenorphine 10 ng/mL
Methylenedioxy-methamphetamine 500 ng/mL
Phencyclidine 25 ng/mL
Methadone 300 ng/mL
Nortriptyline 1000 ng/mL
d-Propoxyphene 300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine 300 ng/mL
Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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 tests are intended for over-the-counter use.
SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Amphetamine 1000 ng/mL
Oxazepam 300 ng/mL
Cocaine 300 ng/mL
Marijuana 50 ng/mL
Methamphetamine 1000 ng/mL
Morphine 2000 ng/mL
Oxycodone 100 ng/mL
Secobarbital 300 ng/mL
Buprenorphine 10 ng/mL
Methylenedioxy-methamphetamine 500 ng/mL
Phencyclidine 25 ng/mL
Methadone 300 ng/mL
Nortriptyline 1000 ng/mL
d-Propoxyphene 300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine 300 ng/mL
Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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 tests are intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201120: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201120
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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