# K221871: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

- Pathway: 510(k) (Traditional)
- Applicant: Healstone Biotech, Inc.
- Decided: Aug 30, 2022 after 63 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945610 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191841: Accurate Multi Panel Drug Urine Test Cup, Healstone Biotech, Inc. (2019) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K221871
Methodology: https://510kreport.com/methodology