Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

K142280 · Healgen Scientific,, LLC · DJG · Oct 16, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142280
• Device Name: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for oxazepam in urine. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use. Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the presult is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of Oxazepam or Morphine in human urine; available in strip, cassette, dip card, or cup formats. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on colored particles. Absence of drug allows antibody-particle binding to immobilized conjugate, forming visible test line; presence of drug above cutoff saturates antibodies, preventing test line formation. Used in point-of-care or home settings by lay users or clinicians. Results are visual; interpreted by user. Preliminary positive results require confirmation via GC/MS. Benefits include rapid, accessible screening for drug presence.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, 2 runs/day), interference testing (no interference from common substances at 100µg/mL), specificity/cross-reactivity studies, and method comparison against GC/MS. Lay-user study (n=140 per test) confirmed ease of use and accuracy across diverse demographics (ages 21 to >50).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: strip, cassette, dip card, cup. Components: monoclonal mouse antibody-coated particles, immobilized drug-conjugate. Stability: 24 months at 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Oxazepam (300 ng/mL cutoff) or Morphine (2000 ng/mL cutoff) in human urine. Intended for over-the-counter and prescription use to provide preliminary drug screening results. Not intended to distinguish between prescription use and abuse. Requires confirmatory testing (GC/MS).

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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) #: k142280

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.