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K Number
K182779
Device Name
ARK EDDP Assay
Manufacturer
ARK Diagnostics, Inc.
Date Cleared
2018-11-21

(51 days)

Product Code
DJR
Regulation Number
862.3620
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
K151395
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 Description

The ARK EDDP Assay is a homogeneous enzyme immunoassay technique used for the analysis of EDDP in human urine. The assay is based on competition between EDDP in the specimen and EDDP labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of EDDP from the specimen, enzyme activity increases and is directly related to the EDDP concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.

The ARK EDDP Assay consists of reagents R1 anti-EDDP rabbit antibody with substrate and R2 EDDP derivative labeled with bacterial recombinant G6PDH enzyme.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ARK EDDP Assay, based on the provided FDA 510(k) summary:

This document describes a medical device, the ARK EDDP Assay, which is an immunoassay for the qualitative and/or semi-quantitative determination of EDDP (a methadone metabolite) in human urine. The study presented is a non-clinical performance evaluation, as indicated by "Brief Description of Nonclinical and Clinical Data" and the nature of the tests (Precision, Analytical Recovery, Analytical Specificity, Interference, etc.). No clinical study involving human patients or human readers in an MRMC setting is described.

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific pass/fail values for each performance characteristic. Instead, performance is evaluated against expected behaviors for an in vitro diagnostic (IVD) device of this type. The inferred acceptance criteria are that the device should demonstrate acceptable precision, accurate analytical recovery, appropriate cross-reactivity and interference profiles, and good agreement with a gold standard (GC/MS) in method comparison for qualitative and semi-quantitative results.

Performance CharacteristicInferred Acceptance Criteria (Implicit)Reported Device Performance and Discussion
PrecisionConsistent qualitative and semi-quantitative results, particularly around the cutoff concentrations.100 ng/mL Cutoff:
- Qualitative (100 ng/mL)All samples ≤ 75 ng/mL should be negative; all samples ≥ 125 ng/mL should be positive. Samples at 100 ng/mL (cutoff) may show mixed results.At 0.0, 25.0, 50.0, and 75.0 ng/mL, all 160 results were Negative. At 125.0, 150.0, 175.0, and 200.0 ng/mL, all 160 results were Positive. At the 100.0 ng/mL cutoff, 123 were Negative and 37 were Positive, which is expected for a cutoff concentration.
- Semiquantitative (100 ng/mL)Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff.Mean concentrations were close to theoretical (e.g., 98.1 ng/mL for 100 ng/mL theoretical). At 100.0 ng/mL cutoff, 114 were Negative and 46 were Positive, consistent with a cutoff.
- Qualitative (300 ng/mL)All samples ≤ 225 ng/mL should be negative; all samples ≥ 375 ng/mL should be positive. Samples at 300 ng/mL (cutoff) may show mixed results.At 0.0, 75.0, 150.0, and 225.0 ng/mL, all 160 results were Negative. At 375.0, 450.0, 525.0, and 600.0 ng/mL, all 160 results were Positive. At the 300.0 ng/mL cutoff, 57 were Negative and 103 were Positive, which is expected.
- Semiquantitative (300 ng/mL)Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff.Mean concentrations were close to theoretical (e.g., 298.8 ng/mL for 300 ng/mL theoretical). At 300.0 ng/mL cutoff, 85 were Negative and 75 were Positive, consistent with a cutoff.
Analytical RecoveryMeasured concentration should be within an acceptable percentage range of the theoretical concentration.Recovery percentages ranged from 94.6% to 107.9% across EDDP concentrations from 50.0 to 1000.0 ng/mL, indicating good analytical recovery.
Analytical SpecificityMinimal to no cross-reactivity with structurally related and unrelated compounds, ensuring specificity for EDDP.Structurally Related Compounds: EDDP showed 100% cross-reactivity (as expected). Methadone and EMDP showed very low cross-reactivity (<0.005% to <0.03%). Several other structurally related compounds (Chlorpromazine, Diphenhydramine, Methylphenidate, Doxylamine) showed low cross-reactivity (<0.1% to <0.3%). This indicates good specificity for EDDP while acknowledging minor cross-reactivity with very high concentrations of certain related compounds.
InterferenceEndogenous substances, specific gravity variations, and pH variations should not cause false positive or false negative results.Structurally Unrelated Compounds: Numerous compounds were tested at high concentrations (e.g., 100,000 ng/mL, 500,000 ng/mL). For both 100 ng/mL and 300 ng/mL cutoffs, none of the listed substances yielded a false result (i.e., they were negative at -25% cutoff EDDP concentration and positive at +25% cutoff EDDP concentration), indicating no significant interference from these compounds even at very high concentrations.
Endogenous Substances: High concentrations of common endogenous substances (e.g., Acetone, Ascorbic Acid, Bilirubin, Creatinine, Ethanol, Glucose, Hemoglobin, etc.) were tested. No interference was observed for either the 100 ng/mL or 300 ng/mL cutoff, meaning they did not cause false results.
Specific Gravity: Urine samples across the physiologic range (1.002 to 1.030) did not show interference for either cutoff, meaning results remained correct (negative at -25% cutoff EDDP, positive at +25% cutoff EDDP).
pH: Urine samples across the physiologic pH range (3.0 to 11.0) did not show interference for either cutoff, meaning results remained correct (negative at -25% cutoff EDDP, positive at +25% cutoff EDDP).
Method ComparisonHigh concordance with the GC/MS gold standard, particularly for samples well above or below the cutoff. Minor discrepancies near the cutoff are acceptable.100 ng/mL Cutoff: 104 out of 109 samples showed perfect agreement with GC/MS (40 Low Negative, 60 High Positive). 5 samples were Near Cutoff Negative by GC/MS but Negative by immunoassay (expected). 4 samples were Near Cutoff Positive by GC/MS but Positive by immunoassay (expected). This shows high concordance.
300 ng/mL Cutoff: 104 out of 109 samples showed perfect agreement with GC/MS (49 Low Negative, 52 High Positive). 4 samples were Near Cutoff Negative by GC/MS but Negative by immunoassay (expected). 3 samples were Near Cutoff Positive by GC/MS but Positive by immunoassay (expected). One discordant result: Sample 51 was Immunoassay Positive but 294 ng/mL by GC/MS (which is slightly below the 300 ng/mL cutoff). This is a single false positive near the cutoff, which can occur for immunoassay methods.
Calibration Curve StabilityCalibration should remain stable for a reasonable period.A stored calibration curve was effective up to at least 15 days, which is an acceptable stability period for a laboratory assay.

2. Sample sizes used for the test set and the data provenance

  • Precision Studies:
    • Target Concentrations: 9 levels for each cutoff (0.0 to 200.0 ng/mL for 100 ng/mL cutoff; 0.0 to 600.0 ng/mL for 300 ng/mL cutoff).
    • Replicates: Quaduplicate twice a day for 20 days.
    • Total Sample Size per Cutoff (for precision): 9 levels * 4 replicates * 2 (times/day) * 20 days = 1440 individual readings for the qualitative precision tables. (Note: The table summary states N=160 for each concentration level, implying 160 results for each of the 9 spiked levels.)
    • Data Provenance: Drug-free, negative human urine (spiked with EDDP). The country of origin is not specified but is likely the U.S. as it's an FDA submission. This is a prospective study (laboratory testing).
  • Analytical Recovery:
    • Target Concentrations: 12 levels (50.0 to 1000.0 ng/mL).
    • Replicates: N=6 for mean concentration calculation.
    • Total Sample Size: 12 levels * 6 replicates = 72 individual readings.
    • Data Provenance: Drug-free, negative human urine (spiked with EDDP). Prospective laboratory testing.
  • Analytical Specificity (Cross-reactivity):
    • Number of Compounds Tested: 7 structurally related compounds.
    • Sample Size: Each compound tested at minimum concentration for positive result (or highest tested) at both cutoff levels. Implies multiple tests per compound, but specific N is not given per compound; typically, this would be triplicate.
    • Data Provenance: Drug-free, negative human urine (spiked with compounds). Prospective laboratory testing.
  • Interference (Structurally Unrelated, Endogenous Substances, Specific Gravity, pH):
    • Number of Compounds/Conditions Tested: Numerous (tens of compounds + SG and pH conditions).
    • Sample Size: Each compound/condition tested at two EDDP levels (±25% of cutoff). Implies multiple tests per condition, but specific N is not given per condition; typically, this would be triplicate.
    • Data Provenance: Drug-free, negative human urine (spiked with EDDP and interferent). Prospective laboratory testing.
  • Method Comparison:
    • Sample Size: 109 unaltered clinical human urine specimens.
    • Data Provenance: "unaltered clinical human urine specimens that are not individually identifiable." Country of origin not specified, but usually implies local (US) clinical samples. Described as "clinical human urine specimens," suggesting these were collected from actual patients, making this a retrospective evaluation of real-world samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for this diagnostic device is established by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), which are highly accurate analytical chemistry techniques considered the gold standard for drug confirmation in urine. These methods are performed in laboratories by trained laboratory professionals (analytical chemists, toxicologists). The document states the GC/MS confirmatory method was performed by a "licensed reference laboratory."

  • Number of experts: Not explicitly stated, as GC/MS analysis is a scientific measurement, not typically an "expert reader" interpretation process like image analysis. The "experts" are the qualified laboratory personnel operating and interpreting the GC/MS results.
  • Qualifications of experts: Implied to be qualified laboratory professionals with expertise in analytical chemistry and toxicology, as they work in a "licensed reference laboratory." Specific certifications or experience years are not given.

4. Adjudication method for the test set

Not applicable. The ground truth is established by a definitive analytical method (GC/MS). There is no "adjudication" in the sense of reconciling disagreements among multiple human readers for an image-based or qualitative assessment. The GC/MS provides a quantitative concentration, which is then used to determine positive/negative relative to the cutoffs. Any "discordance" (like the one noted in the method comparison for Sample 51) is a direct comparison between the immunoassay result and the GC/MS result, not a result of human reader discrepancy requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed to provide an automated analytical result (qualitative or semi-quantitative concentration of EDDP). It is not an imaging AI device that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the primary performance evaluation is standalone. The ARK EDDP Assay is an automated immunoassay performed on clinical chemistry analyzers. The results (qualitative positive/negative or semi-quantitative concentration) are generated by the assay system (reagents + analyzer) without human interpretive input for the result itself. The results are then reported to a clinician for medical interpretation in conjunction with other clinical information. The precision, analytical recovery, specificity, interference, and method comparison studies all represent the "algorithm only" or "device only" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is definitive analytical method (Gas Chromatography/Mass Spectrometry - GC/MS). For in vitro diagnostic assays measuring specific chemical compounds, GC/MS is considered the most accurate and reliable "truth" method.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. For an immunoassay like the ARK EDDP Assay, the "training" (development and optimization) phase would involve numerous laboratory experiments to select reagents, optimize assay conditions, and establish initial performance characteristics. This is distinct from machine learning model training sets. The studies presented (precision, analytical recovery, specificity, interference, method comparison) are performance validation studies for the final device, not datasets used to train an algorithm.

9. How the ground truth for the training set was established

Not applicable in the context of an immunoassay. The "ground truth" for developing an immunoassay would be established by controlled spiking experiments using certified reference materials of the analyte (EDDP) in a known matrix (drug-free human urine), and confirming those concentrations using methods like GC/MS or LC-MS/MS, or by gravimetric/volumetric preparation. The goal is to ensure the assay accurately measures the target compound.

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2018

ARK Diagnostics, Inc. Cherry Mun Manager, Quality and Regulatory Affairs 48089 Fremont Boulevard Fremont, California 94538

Re: K182779

Trade/Device Name: ARK EDDP Assay Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: September 28, 2018 Received: October 1, 2018

Dear Cherry Mun:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula Caposino -S

for Courtnev H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)K182779
Device NameARK EDDP Assay

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)Page 1 of 1
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510(k) SUMMARY

This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is K182779.

807.92 (a)(1): Name:ARK Diagnostics, Inc.
Address:48089 Fremont BlvdFremont, CA 94538 USA
Owner Operator Number:10027663
Establishment Registration:3005755244
Phone:(510) 270-6270
FAX:(510) 270-6298
Contact:Cherry Mun – (510) 270-6288Manager of Quality and Regulatory Affairs

Date Prepared: November 19th, 2018

807.92 (a)(2): Device Name – Trade Name, Common Name, and Classification

Trade Name:ARK™ EDDP Assay
Common Name:Homogeneous Enzyme Immunoassay, Methadone Test System

Classification:

Product CodeClassificationRegulation SectionPanel
DJRClass II21 CFR 862.3620Methadone Test SystemToxicology(91)

807.92 (a)(3): Identification of the Legally Marketed Predicate Device

Immunalysis EDDP Specific Urine Enzyme Immunoassay (K151395)

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807.92 (a)(4): Device Description

The ARK EDDP Assay is a homogeneous enzyme immunoassay technique used for the analysis of EDDP in human urine. The assay is based on competition between EDDP in the specimen and EDDP labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of EDDP from the specimen, enzyme activity increases and is directly related to the EDDP concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.

The ARK EDDP Assay consists of reagents R1 anti-EDDP rabbit antibody with substrate and R2 EDDP derivative labeled with bacterial recombinant G6PDH enzyme.

807.92 (a)(5): Intended Use / Indications for Use

ARK EDDP Assay

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.

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807.92 (a)(6): Technological Similarities and Differences to the Predicate

SUBSTANTIAL EQUIVALENCE COMPARATIVE TABLE

Comparison between the Immunalysis EDDP Specific Urine Enzyme Immunoassay and the ARK™ EDDP Assay

CharacteristicPredicate DeviceImmunalysis EDDP Specific UrineEnzyme Immunoassay (K151395)Candidate DeviceARKTM EDDP Assay
Similarities
Test SystemHomogenous enzyme immunoassay(EIA)Same
Intended UseFor the qualitative and semiquantitativedetermination of EDDP in human urine;For in vitro diagnostic useSame
Sample MatrixHuman urineSame
User EnvironmentClinical laboratories; Prescription useonlySame
Mass SpectrometryConfirmationRequired to confirm preliminary positiveanalytical resultsSame
Platform RequiredAutomated clinical chemistry analyzerSame
Reagents FormLiquid - Ready to useSame
Reagent MaterialsTwo (2) reagent system:Antibody/substrate reagent (antibodies toEDDP) and enzyme labeled conjugate(EDDP derivative labeled with enzyme)Sodium azide preservativeSame
Storage2-8°C until expiration dateSame
Measured AnalyteEDDPSame
DetectionAbsorbance change measuredspectrophotometrically at 340 nmSame
CharacteristicPredicate DeviceImmunalysis EDDP Specific UrineEnzyme Immunoassay (K151395)Candidate DeviceARKTM EDDP Assay
Differences
Cutoff Levels100 ng/mL, 300 ng/mL and 1000 ng/mL100 ng/mL and 300 ng/mL

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807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data

The following performance characteristics were obtained on the Beckman Coulter AU680® automated clinical chemistry analyzer.

Precision

Precision studies were performed using CLSI EP05-A3 as a guideline. Drug-free, negative human urine was supplemented with EDDP (0.0 to 200.0 ng/mL for the 100 ng/mL cutoff and 0.0 to 600.0 for the 300 ng/mL cutoff). Each level was assayed in quadruplicate twice a day for 20 days (N=160) and evaluated qualitatively and semiquantitatively. Results are summarized in the tables below.

Human Urine(ng/mL)Relative %Cutoff# of ResultsQualitativePrecision Results
0.0-100160160 Negative
25.0-75160160 Negative
50.0-50160160 Negative
75.0-25160160 Negative
100.0Cutoff160123 Negative;37 Positive
125.0+25160160 Positive
150.0+50160160 Positive
175.0+75160160 Positive
200.0+100160160 Positive

Qualitative Precision - 100 ng/mL Cutoff

Semiquantitative Precision – 100 ng/mL Cutoff

Human Urine(ng/mL)Relative %Cutoff# of ResultsMean(ng/mL)SemiquantitativePrecision Results
0.0-1001600.3160 Negative
25.0-7516022.6160 Negative
50.0-5016047.7160 Negative
75.0-2516072.2160 Negative
100.0Cutoff16098.1114 Negative;46 Positive
125.0+25160125.3160 Positive
150.0+50160145.1160 Positive
175.0+75160169.4160 Positive
200.0+100160190.7160 Positive

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Qualitative Precision – 300 ng/mL Cutoff

Human Urine(ng/mL)Relative %Cutoff# of ResultsQualitativePrecision Results
0.0-100160160 Negative
75.0-75160160 Negative
150.0-50160160 Negative
225.0-25160160 Negative
300.0Cutoff16057 Negative;103 Positive
375.0+25160160 Positive
450.0+50160160 Positive
525.0+75160160 Positive
600.0+100160160 Positive

Semiquantitative Precision – 300 ng/mL Cutoff

Human Urine(ng/mL)Relative %Cutoff# of ResultsMean(ng/mL)SemiquantitativePrecision Results
0.0-1001600.3160 Negative
75.0-7516072.2160 Negative
150.0-50160145.1160 Negative
225.0-25160205.9160 Negative
300.0Cutoff160298.885 Negative;75 Positive
375.0+25160381.4160 Positive
450.0+50160461.0160 Positive
525.0+75160539.8160 Positive
600.0+100160620.0160 Positive

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Analytical Recovery

Recovery across the assay range was assessed using the semiquantitative mode. Drug-free, negative human urine was supplemented with EDDP (1100.0 ng/mL) and dilutions were made proportionally with drug-free human urine. EDDP concentrations ranged from 50.0 to 1000.0 ng/mL. At each level, percentage recovery was calculated based on the mean concentration (N=6) compared to the expected concentration. Results are summarized in the table below.

TheoreticalConcentration(ng/mL)MeanConcentration(ng/mL)Recovery(%)
50.047.695.1
75.072.196.1
100.097.197.1
200.0189.194.6
300.0286.695.5
400.0414.5103.6
500.0506.6101.3
600.0647.4107.9
700.0722.7103.2
800.0800.6100.1
900.0880.897.9
1000.0955.895.6

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Analytical Specificity

All compounds tested were added to drug-free, negative human urine and tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

The cross-reactivity of the following structurally related compounds was evaluated by spiking these compounds into drug-free, negative human urine to determine the minimum concentration that would give a positive result approximately equivalent to the 100 ng/mL and 300 ng/mL EDDP cutoffs. These concentrations were used to determine the percent cross-reactivity according to the formula:

% Cross-reactivity = (Cutoff concentration / Lowest concentration of cross-reactant causing a positive result) X 100

For compounds that did not produce a positive result, the highest concentration tested was used to calculate percent cross-reactivity.

CompoundConcentrationTested(ng/mL)SemiquantitativeMode Result(Positive/Negative)Qualitative ModeResult(Positive/Negative)Cross-reactivity(%)
EDDP100PositivePositive100
Methadone2,000,000NegativeNegative<0.005
EMDP400,000NegativeNegative<0.025
Chlorpromazine100,000NegativeNegative<0.1
Diphenhydramine100,000NegativeNegative<0.1
Methylphenidate100,000NegativeNegative<0.1
Doxylamine100,000NegativeNegative<0.1

Structurally Related Compounds - 100 ng/mL Cutoff

Structurally Related Compounds - 300 ng/mL Cutoff

CompoundConcentrationTested(ng/mL)SemiquantitativeMode Result(Positive/Negative)Qualitative ModeResult(Positive/Negative)Cross-reactivity(%)
EDDP300PositivePositive100
Methadone4,500,000NegativeNegative<0.007
EMDP1,000,000NegativeNegative<0.03
Chlorpromazine100,000NegativeNegative<0.3
Diphenhydramine100,000NegativeNegative<0.3
Methylphenidate100,000NegativeNegative<0.3
Doxylamine100,000NegativeNegative<0.3

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Interference

Structurally Unrelated Compounds – 100 ng/mL Cutoff

High concentrations of the following structurally unrelated compounds were added into urine spiked with EDDP (± 25% of the 100 ng/mL cutoff concentration) and tested with the ARK EDDP Assay in both qualitative and semiquantitative modes. The substances listed at the concentrations below did not yield a false result relative to the 100 ng/mL cutoff.

CompoundConcentrationTested(ng/mL)Spiked EDDP Level
75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
4-bromo 2-5, dimethoxyphenethylamine100,000NegativePositive
Acetaminophen500,000NegativePositive
Acetylsalicylic Acid500,000NegativePositive
6-Acetylcodeine100,000NegativePositive
6-Acetylmorphine100,000NegativePositive
Alprazolam100,000NegativePositive
7-Aminoclonazepam100,000NegativePositive
7-Aminoflunitrazepam100,000NegativePositive
7-Aminonitrazepam100,000NegativePositive
Amitriptyline100,000NegativePositive
Amobarbital100,000NegativePositive
S-(+)-Amphetamine100,000NegativePositive
Benzylpiperazine100,000NegativePositive
Bromazepam100,000NegativePositive
Buprenorphine100,000NegativePositive
Bupropion100,000NegativePositive
Butabarbital100,000NegativePositive
Butalbital100,000NegativePositive
Caffeine500,000NegativePositive
Cannabidiol100,000NegativePositive
Cannabinol100,000NegativePositive
Carbamazepine100,000NegativePositive
Carisoprodol100,000NegativePositive
Chlordiazepoxide100,000NegativePositive
Cis-Tramadol100,000NegativePositive
Clobazam100,000NegativePositive
Clomipramine100,000NegativePositive
Clonazepam100,000NegativePositive
Clozapine100,000NegativePositive
Codeine100,000NegativePositive
Cotinine100,000NegativePositive
Cyclobenzaprine100,000NegativePositive
Dehydronorketamine100,000NegativePositive
Demoxepam100,000NegativePositive
Desipramine100,000NegativePositive
Desalkylflurazepam100,000NegativePositive
Dextromethorphan100,000NegativePositive

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ConcentrationSpiked EDDP Level
CompoundTested75 ng/mL125 ng/mL
(ng/mL)(-25% Cutoff)(+25% Cutoff)
Diazepam100,000NegativePositive
Digoxin100,000NegativePositive
Dihydrocodeine100,000NegativePositive
Δ9 THC100,000NegativePositive
Doxepin100,000NegativePositive
1R,2S (-) Ephedrine100,000NegativePositive
1S,2R (+) Ephedrine100,000NegativePositive
Ethyl-ß-D-Glucuronide100,000NegativePositive
Ethylmorphine100,000NegativePositive
(S-)-Fenfluramine100,000NegativePositive
(R+)-Fenfluramine100,000NegativePositive
Fentanyl100,000NegativePositive
Flunitrazepam100,000NegativePositive
Fluoxetine100,000NegativePositive
Flurazepam100,000NegativePositive
Haloperidol100,000NegativePositive
Heroin100,000NegativePositive
Hexobarbital100,000NegativePositive
Hydrocodone100,000NegativePositive
Hydromorphone100,000NegativePositive
11-hydroxy-Δ9 THC100,000NegativePositive
Ibuprofen500,000NegativePositive
Imipramine100,000NegativePositive
Ketamine100,000NegativePositive
Lamotrigine100,000NegativePositive
Levorphanol Tartrate100,000NegativePositive
Lidocaine100,000NegativePositive
Lorazepam100,000NegativePositive
Lorazepam Glucuronide50,000NegativePositive
Lormetrazepam100,000NegativePositive
LSD100,000NegativePositive
Maprotiline100,000NegativePositive
(+)-MDA100,000NegativePositive
MDEA100,000NegativePositive
MDMA100,000NegativePositive
Meperidine100,000NegativePositive
Meprobamate100,000NegativePositive
S(+)-Methamphetamine100,000NegativePositive
Methaquolone100,000NegativePositive
Methoxetamine100,000NegativePositive
Methylone100,000NegativePositive
Midazolam100,000NegativePositive
Morphine100,000NegativePositive
Morphine-3B-D-Glucuronide100,000NegativePositive
Morphine-6ß-D-Glucuronide50,000NegativePositive
N-Desmethyltapentadol100,000NegativePositive
Nalorphine100,000NegativePositive

ARK Diagnostics, Inc. – 510(k) Summary ARK EDDP Assay

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CompoundConcentrationTested(ng/mL)Spiked EDDP Level
75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
Naloxone100,000NegativePositive
Naltrexone100,000NegativePositive
Naproxen100,000NegativePositive
Nitrazepam100,000NegativePositive
11-nor-9-carboxy-Δ9-THC100,000NegativePositive
Norbuprenorphine50,000NegativePositive
Norcodeine100,000NegativePositive
Nordiazepam100,000NegativePositive
Norketamine100,000NegativePositive
Normorphine100,000NegativePositive
Norpropoxyphene100,000NegativePositive
Norpseudoephedrine100,000NegativePositive
Nortriptyline100,000NegativePositive
Olanzapine100,000NegativePositive
Oxazepam100,000NegativePositive
Oxycodone100,000NegativePositive
Oxymorphone100,000NegativePositive
PCP100,000NegativePositive
Pentazocine100,000NegativePositive
Pentobarbital100,000NegativePositive
Phenobarbital100,000NegativePositive
Phentermine100,000NegativePositive
Phenylephedrine100,000NegativePositive
Phenylpropanolamine100,000NegativePositive
Phenytoin100,000NegativePositive
PMA100,000NegativePositive
Prazepam100,000NegativePositive
Propoxyphene100,000NegativePositive
Propranolol100,000NegativePositive
Protriptyline100,000NegativePositive
R,R (+)- Pseudoephedrine100,000NegativePositive
S,S (-)- Pseudoephedrine100,000NegativePositive
Ranitidine100,000NegativePositive
Ritalinic Acid100,000NegativePositive
Salicylic Acid100,000NegativePositive
Secobarbital100,000NegativePositive
Sertraline100,000NegativePositive
Sufentanil Citrate50,000NegativePositive
Tapentadol100,000NegativePositive
Temazepam100,000NegativePositive
Theophylline100,000NegativePositive
Thioridazine100,000NegativePositive
Trazodone100,000NegativePositive
Triazolam100,000NegativePositive
Trifluoromethylphenylpiperazine100,000NegativePositive
Trimipramine100,000NegativePositive
Venlafaxine100,000NegativePositive

ARK Diagnostics, Inc. – 510(k) Summary ARK EDDP Assay

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ConcentrationSpiked EDDP Level
CompoundTested(ng/mL)75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
Verapamil100,000NegativePositive
Zolpidem Tartrate100,000NegativePositive

Structurally Unrelated Compounds – 300 ng/mL Cutoff

High concentrations of the following structurally unrelated compounds were added into urine spiked with EDDP (± 25% of the 300 ng/mL cutoff concentration) and tested with the ARK EDDP Assay in both qualitative and semiquantitative modes. The substances listed at the concentrations below did not yield a false result relative to the 300 ng/mL cutoff.

CompoundConcentrationTested(ng/mL)Spiked EDDP Level
225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
4-bromo 2-5, dimethoxyphenethylamine100,000NegativePositive
Acetaminophen500,000NegativePositive
Acetylsalicylic Acid500,000NegativePositive
6-Acetylcodeine100,000NegativePositive
6-Acetylmorphine100,000NegativePositive
Alprazolam100,000NegativePositive
7-Aminoclonazepam100,000NegativePositive
7-Aminoflunitrazepam100,000NegativePositive
7-Aminonitrazepam100,000NegativePositive
Amitriptyline100,000NegativePositive
Amobarbital100,000NegativePositive
S-(+)-Amphetamine100,000NegativePositive
Benzylpiperazine100,000NegativePositive
Bromazepam100,000NegativePositive
Buprenorphine100,000NegativePositive
Bupropion100,000NegativePositive
Butabarbital100,000NegativePositive
Butalbital100,000NegativePositive
Caffeine500,000NegativePositive
Cannabidiol100,000NegativePositive
Cannabinol100,000NegativePositive
Carbamazepine100,000NegativePositive
Carisoprodol100,000NegativePositive
Chlordiazepoxide100,000NegativePositive
Cis-Tramadol100,000NegativePositive
Clobazam100,000NegativePositive
Clomipramine100,000NegativePositive
Clonazepam100,000NegativePositive
Clozapine100,000NegativePositive
Codeine100,000NegativePositive
Cotinine100,000NegativePositive
Cyclobenzaprine100,000NegativePositive
Dehydronorketamine100,000NegativePositive
ConcentrationSpiked EDDP Level
CompoundTested (ng/mL)225 ng/mL (-25% Cutoff)375 ng/mL (+25% Cutoff)
Demoxepam100,000NegativePositive
Desipramine100,000NegativePositive
Desalkylflurazepam100,000NegativePositive
Dextromethorphan100,000NegativePositive
Diazepam100,000NegativePositive
Digoxin100,000NegativePositive
Dihydrocodeine100,000NegativePositive
Δ9 THC100,000NegativePositive
Doxepin100,000NegativePositive
1R,2S (-) Ephedrine100,000NegativePositive
1S,2R (+) Ephedrine100,000NegativePositive
Ethyl-β-D-Glucuronide100,000NegativePositive
Ethylmorphine100,000NegativePositive
(S-)-Fenfluramine100.000NegativePositive
(R+)-Fenfluramine100,000NegativePositive
Fentanyl100,000NegativePositive
Flunitrazepam100,000NegativePositive
Fluoxetine100,000NegativePositive
Flurazepam100,000NegativePositive
Haloperidol100,000NegativePositive
Heroin100,000NegativePositive
Hexobarbital100,000NegativePositive
Hydrocodone100,000NegativePositive
Hydromorphone100,000NegativePositive
11-hydroxy-Δ9 THC100,000NegativePositive
Ibuprofen500,000NegativePositive
Imipramine100,000NegativePositive
Ketamine100,000NegativePositive
Lamotrigine100,000NegativePositive
Levorphanol Tartrate100,000NegativePositive
Lidocaine100,000NegativePositive
Lorazepam100.000NegativePositive
Lorazepam Glucuronide50,000NegativePositive
Lormetrazepam100,000NegativePositive
LSD100,000NegativePositive
Maprotiline100,000NegativePositive
(+)-MDA100,000NegativePositive
MDEA100,000NegativePositive
MDMA100,000NegativePositive
Meperidine100,000NegativePositive
Meprobamate100,000NegativePositive
S(+)-Methamphetamine100,000NegativePositive
Methaquolone100,000NegativePositive
Methoxetamine100,000NegativePositive
Methylone100,000NegativePositive
Midazolam100,000NegativePositive
Morphine100,000NegativePositive
CompoundConcentrationTested(ng/mL)Spiked EDDP Level
225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
Morphine-3β-D-Glucuronide100,000NegativePositive
Morphine-6β-D-Glucuronide50,000NegativePositive
N-Desmethyltapentadol100,000NegativePositive
Nalorphine100,000NegativePositive
Naloxone100,000NegativePositive
Naltrexone100,000NegativePositive
Naproxen100,000NegativePositive
Nitrazepam100,000NegativePositive
11-nor-9-carboxy-Δ9-THC100,000NegativePositive
Norbuprenorphine50,000NegativePositive
Norcodeine100,000NegativePositive
Nordiazepam100,000NegativePositive
Norketamine100,000NegativePositive
Normorphine100,000NegativePositive
Norpropoxyphene75,000NegativePositive
Norpseudoephedrine100,000NegativePositive
Nortriptyline100,000NegativePositive
Olanzapine100,000NegativePositive
Oxazepam100,000NegativePositive
Oxycodone100,000NegativePositive
Oxymorphone100,000NegativePositive
PCP50,000NegativePositive
Pentazocine100,000NegativePositive
Pentobarbital100,000NegativePositive
Phenobarbital100,000NegativePositive
Phentermine100,000NegativePositive
Phenylephedrine100,000NegativePositive
Phenylpropanolamine100,000NegativePositive
Phenytoin100,000NegativePositive
PMA100,000NegativePositive
Prazepam100,000NegativePositive
Propoxyphene100,000NegativePositive
Propranolol100,000NegativePositive
Protriptyline100,000NegativePositive
R,R (+)- Pseudoephedrine100,000NegativePositive
S,S (-)- Pseudoephedrine100,000NegativePositive
Ranitidine100,000NegativePositive
Ritalinic Acid100,000NegativePositive
Salicylic Acid100,000NegativePositive
Secobarbital100,000NegativePositive
Sertraline100,000NegativePositive
Sufentanil Citrate50,000NegativePositive
Tapentadol100,000NegativePositive
Temazepam100,000NegativePositive
Theophylline100,000NegativePositive
Thioridazine100,000NegativePositive
Trazodone100,000NegativePositive
CompoundConcentrationTested(ng/mL)Spiked EDDP Level
225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
Triazolam100,000NegativePositive
Trifluoromethylphenylpiperazine100,000NegativePositive
Trimipramine100,000NegativePositive
Venlafaxine100,000NegativePositive
Verapamil100,000NegativePositive
Zolpidem Tartrate100,000NegativePositive

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ARK Diagnostics, Inc. – 510(k) Summary ARK EDDP Assay

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ARK Diagnostics, Inc. – 510(k) Summary ARK EDDP Assay

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Endogenous Substances – 100 ng/mL Cutoff

Interference studies were performed using CLSI EP07-A2 as a guideline. High concentrations of the following endogenous substances were added into urine spiked with EDDP (± 25% of the 100 ng/mL cutoff concentration). No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

Spiked EDDP Level
CompoundConcentrationTested75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
Acetone1000 mg/dLNegativePositive
Ascorbic Acid1500 mg/dLNegativePositive
Bilirubin – Conjugated2 mg/dLNegativePositive
Bilirubin – Unconjugated2 mg/dLNegativePositive
Boric Acid1% w/vNegativePositive
Creatinine500 mg/dLNegativePositive
Ethanol1000 mg/dLNegativePositive
Galactose10 mg/dLNegativePositive
Gamma Globulin500 mg/dLNegativePositive
Glucose2000 mg/dLNegativePositive
Hemoglobin300 mg/dLNegativePositive
Human Albumin500 mg/dLNegativePositive
Oxalic Acid100 mg/dLNegativePositive
Riboflavin7.5 mg/dLNegativePositive
Sodium Azide1% w/vNegativePositive
Sodium Chloride6000 mg/dLNegativePositive
Sodium Fluoride1% w/vNegativePositive
Urea6000 mg/dLNegativePositive

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Endogenous Substances – 300 ng/mL Cutoff

Interference studies were performed using CLSI EP07-A2 as a guideline. High concentrations of the following endogenous substances were added into urine spiked with EDDP (± 25% of the 300 ng/mL cutoff concentration). No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

CompoundConcentrationTestedSpiked EDDP Level
225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
Acetone1000 mg/dLNegativePositive
Ascorbic Acid1500 mg/dLNegativePositive
Bilirubin – Conjugated2 mg/dLNegativePositive
Bilirubin – Unconjugated2 mg/dLNegativePositive
Boric Acid1% w/vNegativePositive
Creatinine500 mg/dLNegativePositive
Ethanol1000 mg/dLNegativePositive
Galactose10 mg/dLNegativePositive
Gamma Globulin500 mg/dLNegativePositive
Glucose2000 mg/dLNegativePositive
Hemoglobin300 mg/dLNegativePositive
Human Albumin500 mg/dLNegativePositive
Oxalic Acid100 mg/dLNegativePositive
Riboflavin7.5 mg/dLNegativePositive
Sodium Azide1% w/vNegativePositive
Sodium Chloride6000 mg/dLNegativePositive
Sodium Fluoride1% w/vNegativePositive
Urea6000 mg/dLNegativePositive

Specific Gravity - 100 ng/mL Cutoff

Urine samples with specific gravity values ranging from 1.002 to 1.030 were tested in the presence of the two levels of EDDP at ± 25% of the 100 ng/mL cutoff concentration. No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

Spiked EDDP Level
Compound75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
Specific Gravity 1.002NegativePositive
Specific Gravity 1.004NegativePositive
Specific Gravity 1.012NegativePositive
Specific Gravity 1.018NegativePositive
Specific Gravity 1.019NegativePositive
Specific Gravity 1.026NegativePositive
Specific Gravity 1.030NegativePositive

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Specific Gravity - 300 ng/mL Cutoff

Urine samples with specific gravity values ranging from 1.002 to 1.030 were tested in the presence of the two levels of EDDP at ± 25% of the 300 ng/mL cutoff concentration. No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

Spiked EDDP Level
Compound225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
Specific Gravity 1.002NegativePositive
Specific Gravity 1.004NegativePositive
Specific Gravity 1.012NegativePositive
Specific Gravity 1.018NegativePositive
Specific Gravity 1.019NegativePositive
Specific Gravity 1.026NegativePositive
Specific Gravity 1.030NegativePositive

pH – 100 ng/mL Cutoff

Urine samples with pH values from 3.0 to 11.0 were tested in the presence of the two levels of EDDP at ± 25% of the 100 ng/mL cutoff concentration. No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

Spiked EDDP Level
Compound75 ng/mL(-25% Cutoff)125 ng/mL(+25% Cutoff)
Urine pH 3.0NegativePositive
Urine pH 4.0NegativePositive
Urine pH 5.0NegativePositive
Urine pH 6.0NegativePositive
Urine pH 7.0NegativePositive
Urine pH 8.0NegativePositive
Urine pH 9.0NegativePositive
Urine pH 10.0NegativePositive
Urine pH 11.0NegativePositive

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pH – 300 ng/mL Cutoff

Urine samples with pH values from 3.0 to 11.0 were tested in the presence of the two levels of EDDP at ± 25% of the 300 ng/mL cutoff concentration. No interference was observed when tested with the ARK EDDP Assay in both qualitative and semiquantitative modes.

Spiked EDDP Level
Compound225 ng/mL(-25% Cutoff)375 ng/mL(+25% Cutoff)
Urine pH 3.0NegativePositive
Urine pH 4.0NegativePositive
Urine pH 5.0NegativePositive
Urine pH 6.0NegativePositive
Urine pH 7.0NegativePositive
Urine pH 8.0NegativePositive
Urine pH 9.0NegativePositive
Urine pH 10.0NegativePositive
Urine pH 11.0NegativePositive

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Method Comparison

A total of one hundred nine (109) unaltered clinical human urine specimens that are not individually identifiable were analyzed for EDDP at the two cutoff levels with the ARK EDDP Assay in both qualitative and semiquantitative modes and the results were compared to GC/MS. The GC/MS confirmatory method was performed by a licensed reference laboratory. Results are summarized in the tables below.

Method Comparison - 100 ng/mL Cutoff

ARKImmunoassayResultLow NegativeLess than50% belowthe Cutoff(< 50 ng/mLby GC/MS)Near CutoffNegativeBetween 50%below theCutoff and theCutoff(50 — 99ng/mL byGC/MS)Near CutoffPositiveBetween theCutoff and50% abovethe Cutoff(100 - 150ng/mL byGC/MS)High PositiveGreater than50% abovethe Cutoff(> 150 ng/mLby GC/MS)
Negative40500
Positive00460

Method Comparison – 300 ng/mL Cutoff

ARKImmunoassayResultLow NegativeLess than50% belowthe Cutoff(< 150 ng/mLby GC/MS)Near CutoffNegativeBetween 50%below theCutoff and theCutoff(150 – 299ng/mL byGC/MS)Near CutoffPositiveBetween theCutoff and50% abovethe Cutoff(300 - 450ng/mL byGC/MS)High PositiveGreater than50% abovethe Cutoff(> 450 ng/mLby GC/MS)
Negative49400
Positive01*352

*Discordant Result

Sample ID NumberARK ImmunoassayResultEDDP(ng/mL by GC/MS)
51Positive294

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Traceability and Value Assignment

ARK EDDP Calibrators and Controls are prepared by volumetric dilution of high purity EDDP (certified solution traceable to HPLC) into non-sterile, processed human urine free of EDDP. Testing is performed with the ARK EDDP Assay on the Beckman Coulter AU680 automated clinical chemistry analyzer, calibrated with the ARK EDDP Calibrator.

Calibration Curve Stability

A stored calibration curve was effective up to at least 15 days based on supporting data. Calibration curve stability may depend on individual laboratory performance.

807.92 (b)(3): Conclusions from Nonclinical Testing

As summarized above, the ARK EDDP Assay is substantially equivalent to the legally marketed predicate device, Immunalysis EDDP Specific Urine Enzyme Immunoassay (K151395).

§ 862.3620 Methadone test system.

(a)
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.(b)
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).