Accurate Multi Panel Drug Urine Test Cup

K191841 · Healstone Biotech, Inc. · NFT · Aug 7, 2019 · Clinical Toxicology

Device Facts

• Record ID: K191841
• Device Name: Accurate Multi Panel Drug Urine Test Cup
• Applicant: Healstone Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of cutoffs]. Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Device is a lateral flow immunochromatographic test cup for qualitative detection of drugs of abuse in human urine. User adds urine sample to cup; sample migrates via capillary action. Competitive binding principle: if drug concentration is below cutoff, drug-conjugate binds to antibody-coated particles, forming a visible test line; if above cutoff, drug saturates binding sites, preventing test line formation. Control line confirms proper test performance. Used in clinical or home settings by professionals or lay users. Results are visual; healthcare providers use preliminary results to guide clinical decision-making, requiring confirmatory testing (GC/MS or LC/MS) for definitive diagnosis. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance testing (precision, interference, specificity, method comparison against GC/MS or LC/MS) and a lay-user study. Lay-user study included 314 participants (184 male/126 female for Config 1; 178 male/132 female for Config 2) with diverse backgrounds, demonstrating high agreement with professional results across various drug concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay. Materials: test cup, test strips, desiccant. Principle: competitive binding antigen-antibody reaction. Form factor: multi-panel test cup. Connectivity: none (standalone). Sterilization: not specified. Software: none.

Indications for Use

Indicated for qualitative, simultaneous detection of 15 specific drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) in human urine. Intended for both professional and over-the-counter (OTC) use. Provides preliminary results; requires GC/MS or LC/MS confirmation.

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: k191841

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.