ARK EDDP Assay

K182779 · Ark Diagnostics, Inc. · DJR · Nov 21, 2018 · Clinical Toxicology

Device Facts

• Record ID: K182779
• Device Name: ARK EDDP Assay
• Applicant: Ark Diagnostics, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Nov 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Indications for Use

The ARK EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 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 semiquantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures. The ARK EDDP Assay provides only a preliminary analytical test 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 EDDP Assay is a homogeneous enzyme immunoassay for detecting EDDP in human urine. Input: urine specimen. Principle: competitive binding between EDDP in specimen and EDDP-labeled recombinant G6PDH enzyme for antibody binding sites. Output: absorbance change measured spectrophotometrically at 340 nm; enzyme activity is directly proportional to EDDP concentration. Used in clinical laboratories on automated chemistry analyzers by laboratory personnel. Provides preliminary results; requires confirmation by GC/MS or LC-MS/MS. Clinical decision-making relies on confirmed results; aids in identifying EDDP presence for clinical or quality control purposes.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A3 (N=160 per level). Analytical recovery (95.1-107.9%) and specificity tested against structurally related and unrelated compounds. Interference studies (endogenous substances, pH, specific gravity) showed no interference. Method comparison performed on 109 clinical urine specimens against GC/MS reference method, showing high concordance at 100 ng/mL and 300 ng/mL cutoffs.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: R1 (anti-EDDP rabbit antibody with substrate) and R2 (EDDP derivative labeled with bacterial recombinant G6PDH). Detection: spectrophotometric absorbance at 340 nm. Platform: automated clinical chemistry analyzers. Storage: 2-8°C. Preservative: sodium azide.

Indications for Use

Indicated for qualitative and/or semiquantitative determination of EDDP in human urine at 100 ng/mL and 300 ng/mL cutoffs. Intended for prescription use in clinical laboratories using automated chemistry analyzers.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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: k182779

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.