Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

K150791 · Healgen Scientific,, LLC · DIS · Apr 24, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150791
• Device Name: Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: DIS · Clinical Toxicology
• Decision Date: Apr 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Indications for Use

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300 ng/mL. 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 the prescription drug Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital 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 prescription and for over-the-counter use. Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 ng/mL. 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 the prescription drug Burrenorphine 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 Buprenorphine 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 prescription and for over-the-counter use. Healgen Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300 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 preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of Secobarbital, Buprenorphine, and Methadone in human urine. Device formats include strip, cassette, dip card, and cup. Principle: competitive binding; target drug in sample competes 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 line. If drug concentration exceeds cutoff, binding sites are saturated, preventing line formation. Control line confirms proper test performance. Used in point-of-care or home settings by lay users or professionals. Results are visual; interpreted by the user to determine presence of drug above specified cutoff. Preliminary positive results require confirmation via GC/MS. Benefits include rapid, accessible screening for drugs of abuse.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed. Method comparison against GC/MS using 80 clinical samples per format showed high concordance. Lay-user study (n=560 per analyte, total 1680) demonstrated correct results ranging from 90-100% across various concentrations relative to cutoff. No clinical studies required.

Technological Characteristics

Lateral flow chromatographic immunoassay. Competitive binding principle using monoclonal mouse antibodies. Formats: strip, cassette, dip card, cup. Specimen: human urine. Stability: 4-30°C for 24 months. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of Secobarbital (300 ng/mL), Buprenorphine (10 ng/mL), and Methadone (300 ng/mL) in human urine. Intended for prescription and OTC use to provide preliminary screening results. Not for distinguishing between prescription use and abuse. Requires confirmatory testing (GC/MS).

Regulatory Classification

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 MEMORANDUM

510(k) #: K150791

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.