510(k) · Cleared
ClearedHealstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healstone Biotech, Inc. · NFT Test, Amphetamine, Over The Counter
Cleared on Aug 30, 2022 as substantially equivalent to K191841 (Healstone Biotech, Inc., 2019) after a 63-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Aug 30, 2022
- Review
- 63 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945610 (1995). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 7 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 6 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 5 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 4 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 3 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 2 generations backK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- 1 generation backK191841 Accurate Multi Panel Drug Urine Test CupHealstone Biotech, Inc. · 2019
- This deviceK221871 Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone…Healstone Biotech, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −7 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −6 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −5 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −4 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −2 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| −1 | K191841 | Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech, Inc. | 2019 | — |
| 0 (this device) | K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM)… | Healstone Biotech, Inc. | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K191841 | Accurate Multi Panel Drug Urine Test CupSummary page 8…NFW 862.3870, Cannabinoids Test Toxicology Cannabinoids (THC 50) System 6. Predicate Device K191841 Healstone AccurateTM Multi Panel Drug Urine Test Cup 7. Intended Use The Healstone Accurate ™ Drug o… | 2019 |
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 27 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 29 ancestors have a recall of any class.
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. 2022, 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?
The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. CODE SUBSTANCE CUT-OFF (ng/mL) AMP Amphetamine 1000 or 500 BUP Buprenorphine 10 BAR Secobarbital 300 BZO Oxazepam 300 COC Cocaine 300 or 150 EDDP 2-ethylidene-1, 5-dimethyl-3, 3- 300 diphenylpyrrolidine…
Read the full statement (325 words)
The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more drugs.
This is not a screening device to monitor prescription medication.
CODE SUBSTANCE CUT-OFF (ng/mL)
AMP Amphetamine 1000 or 500
BUP Buprenorphine 10
BAR Secobarbital 300
BZO Oxazepam 300
COC Cocaine 300 or 150
EDDP 2-ethylidene-1, 5-dimethyl-3, 3- 300
diphenylpyrrolidine
MET/mAMP Methamphetamine 1000 or 500
MDMA 3,4-methylenedioxy-methamphetamine 500
OPI/MOP Morphine 2000 or 300
MTD Methadone 300
OXY Oxycodone 100
PCP Phencyclidine 25
PPX Propoxyphene 300
TCA Nortriptyline 1000
THC Marijuana 50
This drug test cup may contain any combination of the drug tests listed in the table above.
This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.
For in vitro diagnostic use only.
The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more drugs.
This is not a screening device to monitor prescription medication.
CODE SUBSTANCE CUT-OFF (ng/mL)
AMP Amphetamine 1000 or 500
BUP Buprenorphine 10
BAR Secobarbital 300
BZO Oxazepam 300
COC Cocaine 300 or 150
EDDP 2-ethylidene-1, 5-dimethyl-3, 3- 300
diphenylpyrrolidine
MET/mAMP Methamphetamine 1000 or 500
MDMA 3,4-methylenedioxy-methamphetamine 500
OPI/MOP Morphine 2000 or 300
MTD Methadone 300
OXY Oxycodone 100
PCP Phencyclidine 25
PPX Propoxyphene 300
TCA Nortriptyline 1000
THC Marijuana 50
This drug test cup may contain any combination of the drug tests listed in the table above.
This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.
It is intended for prescription use. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221871: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221871
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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