HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx

K220685 · Qingdao Hightop Biotech Co., Ltd. · NFT · May 5, 2022 · Clinical Toxicology

Device Facts

• Record ID: K220685
• Device Name: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
• Applicant: Qingdao Hightop Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: May 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Hightop® Multi-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. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine, 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 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

Rapid, single-use, lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Input: human urine sample added to test cup; capillary action moves sample through test strip. Principle: competitive binding antigen-antibody reaction. If drug concentration is below cutoff, target drug does not saturate antibody-coated particles, allowing capture by immobilized drug-conjugate to form visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence. Used in OTC or clinical settings; operated by patients or healthcare providers. Output: visual qualitative result (positive/negative). Healthcare providers use results for preliminary screening; positive results require confirmatory testing via GC/MS or LC/MS. Benefits: rapid, preliminary identification of drug presence to guide clinical decision-making.

Clinical Evidence

Bench testing only. Analytical performance validated via precision studies (20 days, 3 lots), interference testing (100+ substances), and specificity/cross-reactivity. Method comparison study performed in-house with 80 samples compared to LC/MS. Lay-user study (n=280) conducted across three sites with diverse demographics; results showed high concordance with LC/MS and confirmed ease of use.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use test cup format. Includes test device, desiccant, and package insert. No electronic components or software algorithms. Sterilization not specified. Materials: standard lateral flow membrane components.

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, Cannabinoids) in human urine. Intended for OTC or prescription use. Not for distinguishing between prescription use and abuse. Requires confirmatory testing (GC/MS or LC/MS).

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 MEMORANDUM

510(k) Number: k220685

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.