ARK Fentanyl II Assay

K200197 · Ark Diagnostics, Inc. · DJG · Feb 26, 2020 · Clinical Toxicology

Device Facts

• Record ID: K200197
• Device Name: ARK Fentanyl II Assay
• Applicant: Ark Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Feb 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The ARK Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. The ARK Fentanyl II Assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed positive analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

Device Story

ARK Fentanyl II Assay is a homogeneous enzyme immunoassay for qualitative fentanyl detection in human urine. Input: human urine specimen. Principle: competitive binding between drug in specimen and drug labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites; presence of drug increases enzyme activity, converting NAD to NADH, measured spectrophotometrically at 340 nm. Output: preliminary qualitative result (positive/negative) relative to 1.0 ng/mL cutoff. Used in clinical laboratories by trained personnel on automated clinical chemistry analyzers. Results require confirmation by GC/MS or LC-MS/MS. Clinical utility: aids in identifying fentanyl presence; supports clinical decision-making regarding drug use; requires professional judgment for interpretation.

Clinical Evidence

Method comparison study performed on 147 unaltered clinical urine specimens using the Beckman Coulter AU680 analyzer. Results compared against LC-MS/MS (cutoff 0.2 ng/mL). Precision evaluated per CLSI EP05-A3 (N=160 per level). Interference studies (endogenous substances, pH, specific gravity) performed per CLSI EP07-A3. No clinical data provided; performance established via bench testing and method comparison.

Technological Characteristics

Homogeneous enzyme immunoassay (EIA). Reagents: R1 (anti-fentanyl monoclonal antibodies with substrate) and R2 (fentanyl derivative labeled with bacterial recombinant G6PDH). Detection: spectrophotometric absorbance change at 340 nm. Platform: automated clinical chemistry analyzer. Storage: 2-8°C. Preservative: sodium azide. Boric acid is contraindicated.

Indications for Use

Indicated for qualitative detection of fentanyl in human urine at 1.0 ng/mL cutoff. For use in clinical laboratories with automated chemistry analyzers. Prescription use only. Requires confirmatory testing via GC/MS or LC-MS/MS for positive results.

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) Number: k200197

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.