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

K221871 · Healstone Biotech, Inc. · NFT · Aug 30, 2022 · Clinical Toxicology

Device Facts

• Record ID: K221871
• Device Name: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
• Applicant: Healstone Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

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. 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.

Device Story

Rapid, single-use, lateral flow chromatographic immunoassay for qualitative detection of drugs of abuse in human urine. Urine sample absorbed into test strip; migrates via capillary action. Competitive binding principle: target drug below cutoff level allows antibody-coated particles to bind immobilized drug-conjugate, forming visible colored test line; drug above cutoff saturates binding sites, preventing test line formation. Control line forms regardless of drug presence. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires confirmation by GC/MS. Benefits patient by enabling rapid, point-of-care screening for potential drug abuse.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, 3 lots), interference testing (100+ compounds), specificity/cross-reactivity, and method comparison against LC/MS or GC/MS. Method comparison study included 80 samples per analyte. Lay-user study (n=280) confirmed ease of use and performance across diverse educational backgrounds.

Technological Characteristics

Lateral flow chromatographic immunoassay. Single-use test cup. Analyte-specific monoclonal antibody-coated particles. Competitive binding principle. No electronic components or external energy source. Stable at 2-30°C for 24 months.

Indications for Use

Indicated for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methamphetamine, Methylenedioxymethamphetamine (MDMA), Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, and Cannabinoids in human urine. Intended for both over-the-counter and prescription use.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k221871

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.