Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K231137 · Xenta Biomedical Science Co., Ltd. · DKZ · May 19, 2023 · Clinical Toxicology

Device Facts

• Record ID: K231137
• Device Name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
• Applicant: Xenta Biomedical Science Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Barbiturates (BAR) Benzodiazepines (BZO) Amphetamine (AMP) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) - Calibrator Secobarbital Oxazepam D-Amphetamine Methadone Oxycodone Phencyclidine Cut-off level 300 ng/mL 300 ng/mL 1000 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use. The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow chromatographic immunoassays for qualitative detection of drugs of abuse in human urine. Competitive binding principle; antigen-antibody immunochemistry. Device formats: Test Cup and Test Dipcard. Used at point-of-care by healthcare professionals. Input: human urine sample. Output: visual test line (qualitative). No instrumentation required. Results are preliminary; GC/MS recommended for confirmation. Clinical judgment required for interpretation. Benefits: rapid, on-site screening for drug presence.

Clinical Evidence

Clinical accuracy study using 80 urine samples per drug, analyzed by GC/MS and subject device. Samples categorized as drug-free, <50% cutoff, near-cutoff negative, near-cutoff positive, and high positive. Results showed high concordance with GC/MS. Discordant results observed near cutoff levels. Stability of test lines confirmed between 3-50 minutes.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Formats: Test Cup and Test Dipcard. Urine specimen. Visual readout. No energy source required. Non-instrumented. Software: None.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites (BAR, BZO, AMP, MTD, OXY, PCP) in human urine for prescription use. Intended for in vitro diagnostic 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 MEMORANDUM

510(k) Number: K231137

This 510(k) was reviewed under the OHT7/OHT8 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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