AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

K181768 · Assure Tech. (Hangzhou) Co, Ltd. · NFT · Aug 20, 2018 · Clinical Toxicology

Device Facts

• Record ID: K181768
• Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
• Applicant: Assure Tech. (Hangzhou) Co, Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs provided]. Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

AssureTech Panel Dip Tests and Quick Cup Tests are lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Device formats include dip cards or cups. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored line. If drug concentration exceeds cutoff, binding sites are saturated, preventing line formation. Control line indicates proper test performance. Used by lay users (OTC) or clinicians for preliminary screening. Results require confirmation via GC/MS or LC/MS. Benefits include rapid, simultaneous screening for multiple analytes to support clinical decision-making regarding drug use.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, two runs/day), interference testing with common physiological/pathological substances, and specificity/cross-reactivity analysis. Method comparison study performed with 80 clinical samples per drug compared to GC/MS. Lay-user study (n=310 per format) confirmed ease of use and performance across diverse demographics (ages 18 to >50).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Panel Dip Cards or Cups. Single-use. Analyte detection via monoclonal mouse antibodies. Stable at 4-30°C. No electronic components; non-networked.

Indications for Use

Indicated for qualitative detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene) in human urine. Intended for over-the-counter and prescription use. Not intended to distinguish between prescription use and abuse.

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: k181768

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.