← Product Code [PTH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/PTH) · K180255

# CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K180255)

_Hangzhou Clongene Biotech Co., Ltd. · PTH · Feb 28, 2018 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/PTH/K180255

## Device Facts

- **Applicant:** Hangzhou Clongene Biotech Co., Ltd.
- **Product Code:** [PTH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/PTH.md)
- **Decision Date:** Feb 28, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3150
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of: [Table of drugs/cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam. Secobarbital 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 method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone in human urine at the cutoff concentrations of: [Table of drugs/cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam. Secobarbital 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 alternical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

## Device Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Input: urine sample. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on particles. Output: visual colored lines on test strip; presence of line indicates drug concentration below cutoff; absence of line indicates concentration above cutoff. Used in home or clinical settings by lay users or professionals. Provides preliminary results; requires confirmation by GC/MS or LC/MS. Benefits: rapid, point-of-care screening for drug presence.

## Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing (precision, interference, specificity, cross-reactivity, stability) and a lay-user study (n=300 per device format) comparing results to GC/MS. Lay-user study demonstrated high concordance with GC/MS across various drug concentrations relative to cutoffs.

## Technological Characteristics

Lateral flow immunochromatographic assay. Single-use device. Components: Dip Card or Easy Cup, urine collection cup, desiccant, aluminum pouch. Principle: competitive binding using monoclonal mouse antibodies. Qualitative visual readout. No electronic components or software.

## Regulatory Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). A barbiturate 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: k180255

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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/PTH/K180255](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/PTH/K180255)

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