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K Number
K211973
Device Name
DRI Cocaine Metabolite Assay
Manufacturer
Microgenics Corporation
Date Cleared
2021-09-24

(91 days)

Product Code
DIO
Regulation Number
862.3250
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
K181499
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer.

The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

Device Description

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine samplefor a fixed amount of specific antibody binding sites. In the presence of free drug fromthe sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The assay consists of reagents (A and E).

Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative.

Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

AI/ML Overview

The provided text describes the analytical performance studies for the DRI Cocaine Metabolite Assay, an in vitro diagnostic device, rather than an AI-powered medical device requiring human-in-the-loop studies or expert consensus for ground truth. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this submission.

However, I can extract information related to the acceptance criteria and performance of this in vitro diagnostic device.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results presented in the analytical performance studies. The device is expected to accurately categorize samples as negative or positive relative to defined cutoffs (150 ng/mL or 300 ng/mL) and demonstrate good precision, linearity, and minimal interference.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Study/CharacteristicAcceptance Criteria (Implied)Reported Device Performance
PrecisionHigh concordance for samples spiked above and below the cutoff concentrations; variable results around the cutoff are expected but within an acceptable range.150 ng/mL cutoff: - Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)- Above cutoff (+25% to +100%): 100% Positive (0/120 or 0/119)- At cutoff (150 ng/mL): Qualitative: 76/44 (N/P), Semi-Quantitative: 73/47 (N/P)300 ng/mL cutoff: - Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)- Above cutoff (+25% to +100%): 100% Positive (0/120)- At cutoff (300 ng/mL): Qualitative: 44/76 (N/P), Semi-Quantitative: 42/77 (N/P)
Spike RecoverySamples spiked below cutoff should be negative; samples spiked above cutoff should be positive.150 ng/mL cutoff: - 112.5 ng/mL (below C/O): 25/25 Negative- 187.5 ng/mL (above C/O): 25/25 Positive300 ng/mL cutoff: - 225 ng/mL (below C/O): 25/25 Negative- 375 ng/mL (above C/O): 25/25 Positive
LinearityObserved concentrations should be within an acceptable recovery range of expected concentrations across the assay range.Excellent linearity demonstrated over the range 0 to 1032.2 ng/mL. Percent recovery from 95.7% to 111.4%.
Method Comparison (Accuracy)High agreement (concordance) with the confirmatory method (LC-MS/MS). Discordant results should be minimal and explainable.150 ng/mL cutoff (Semi-Quantitative & Qualitative): - Agreement among Positives: 100% (51/51)- Agreement among Negative: 98% (49/50)- 1 discordant result (Device: Positive, LC-MS/MS: 134 ng/mL, which is below 150 ng/mL cutoff)300 ng/mL cutoff (Semi-Quantitative & Qualitative): - Agreement among Positives: 100% (50/50)- Agreement among Negative: 96% (48/50)- 2 discordant results (Device: Positive, LC-MS/MS: 268 ng/mL and 211 ng/mL, both below 300 ng/mL cutoff)
Specificity (Cross-Reactivity)Minimal cross-reactivity with structurally related or unrelated compounds at specified concentrations.Cocaine and metabolites: - Benzoylecgonine: 100%- Cocaine: 0.6%- Cocaethylene: 0.5%- Ecgonine: 0.17-0.19%- Ecgonine Methyl Ester: <0.15-0.3%- m-hydroxybenzoylecgonine: 50%- Norcocaine: <0.15-0.3%Structurally Unrelated Compounds: For over 70 compounds tested (including common medications, illicit drugs, and physiological substances), the assay accurately detected low controls as negative and high controls as positive, indicating no significant cross-reactivity at the tested concentrations.
InterferencePerformance should not be significantly affected by common endogenous and exogenous substances within physiological and supra-physiological ranges, nor by pH variations.All tested compounds (e.g., Acetaminophen, Creatinine, Ethanol, Glucose, Hemoglobin, Ibuprofen) at high concentrations and pH levels (3-11) did not interfere with the accurate classification of spiked low (negative) and high (positive) controls.
Specific GravityTest results should not be affected by variations in urine specific gravity within a normal range.Urine samples with specific gravity ranging from 1.004 to 1.029, spiked with Benzoylecgonine at low and high control concentrations, were accurately classified (low control negative, high control positive), demonstrating no interference from specific gravity.

Study Details (for an In Vitro Diagnostic Device)

  1. Sample Size Used for the Test Set and Data Provenance:

    • Precision Study: For each cutoff (150 ng/mL and 300 ng/mL), samples were tested in replicates of 3, twice per day for 20 days, totaling n=120 for each of the 9 spiked concentrations (e.g., 0 ng/mL, 37.5 ng/mL, ... 300 ng/mL for 150 ng/mL cutoff). This is 9 concentrations * 120 determinations = 1080 determinations per cutoff for precision.
    • Spike Recovery: 25 replicates for each of two concentrations (below and above cutoff) for each cutoff level. 2 concentrations * 25 replicates = 50 replicates per cutoff.
    • Linearity: 9 intermediate levels and 2 end points (0 and 1032.2 ng/mL), each run in replicates of five. 11 levels * 5 replicates = 55 replicates.
    • Method Comparison (Accuracy): "At least one hundred patient samples" were analyzed by the device and compared to LC-MS/MS. The tables show results for a total of 101 samples for the 150 ng/mL cutoff (12 negative + 33 <50% + 5 Near Cutoff Negative + 5 Near Cutoff Positive + 46 High Positives = 101). A similar number would apply for the 300 ng/mL cutoff.
    • Specificity (Cross-Reactivity) and Interference: Varied number of spiked samples (low and high controls) for each of the numerous compounds tested. The exact sample size for each compound is not explicitly stated but implies sufficient testing to demonstrate the effect (or lack thereof) on the low and high controls.
    • Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "retrospective" or "prospective" is not specified but given the nature of in vitro diagnostic analytical performance studies, they are typically laboratory-based studies using prepared or banked samples, which could be considered prospective (purposefully created) or using retrospective (previously collected) clinical samples. The "Method Comparison" section explicitly mentions "patient samples", suggesting clinical samples.

  2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

    • Not applicable as this is an in vitro diagnostic device for quantitative and qualitative determination of a specific analyte, not an AI/ML device requiring human expert annotation of images or complex data. The "ground truth" for method comparison studies is established by a well-accepted, highly sensitive and specific confirmatory method, in this case, Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

  3. Adjudication Method:

    • Not applicable for this type of device. Discrepancies between the device and the reference method (LC-MS/MS) are reported and discussed (e.g., the 1 discordant result for 150 ng/mL cutoff, and 2 for 300 ng/mL cutoff in the method comparison).

  4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device that involves human reader interpretation. No human readers are involved in performing or interpreting the results of this chemical assay after the initial lab technician operates the Alinity c analyzer.

  5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

    • This is effectively a standalone device. The device (Alinity c Cocaine assay) generates a result (qualitative or semi-quantitative concentration) based on its chemical reactions and spectrophotometric measurements. The human "in the loop" would be the laboratory personnel operating the analyzer and reviewing the results, but the analytical performance described is of the device itself.

  6. Type of Ground Truth Used:

    • Confirmatory Method: For accuracy and method comparison studies, the ground truth was established by Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), which is considered a gold standard confirmatory method for drug testing.
    • Known Spiked Concentrations: For precision, spike recovery, linearity, specificity, interference, and specific gravity studies, the ground truth was established by preparing urine samples with known, precise concentrations of the analyte (Benzoylecgonine) or interfering substances.

  7. Sample Size for the Training Set:

    • Not applicable. This is not an AI/ML device that undergoes a "training" phase on a specific dataset. Its performance is based on its electrochemical and optical principles.

  8. How the Ground Truth for the Training Set Was Established:

    • Not applicable, as there is no "training set" in the context of an AI/ML model. The chemical and performance characteristics of the assay are intrinsic to its design and manufacturing.

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September 24, 2021

Microgenics Corporation Nikhita Tandon Regulatory Affairs Specialist III 46500 Kato Road Fremont, California 94538

Re: K211973

Trade/Device Name: DRI Cocaine Metabolite Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: June 22, 2021 Received: June 25, 2021

Dear Nikhita Tandon:

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

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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 801); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Food and Drug Administration

Enclosure

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Indications for Use

510(k) Number (if known) K211973

Device Name DRI Cocaine Metabolite Assay

Indications for Use (Describe)

The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer.

The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

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)

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510(k) Summary

510(k)#: K211973

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

A. Device Information
CategoryComments
Sponsor:Microgenics CorporationThermo Fisher Scientific46500 Kato RoadFremont, CA 94538Phone: 510-979-5000FAX: 510-979-5002
Correspondent ContactInformation:Nikhita TandonRegulatory Affairs Specialist IIIEmail: nikhita.tandon@thermofisher.comPhone: 510-979-5000Cell:678-964-5599FAX: 510-979-5002
Device Common Name:Cocaine Metabolite Enzyme Immunoassay
Trade or Proprietary NameDRI Cocaine Metabolite Assay
Brand NameAlinity c Cocaine Assay
Predicate Device ProductCode, Classification,Classification Name & PanelDIO, Class II, 21 CFR 862. 3250 – Opiate testsystem, 91 - Toxicology

Predicate Device Information:

Predicate Device:DRI Cocaine Metabolite Assay
Predicate Device Manufacturer:Microgenics Corporation
Predicate Device Common NameCocaine Metabolite Enzyme Immunoassay
Predicate Device Premarket Notification #:K181499
Predicate Device Product Code, Classification, Classification Name & PanelDIO, Class II, 21 CFR 862. 3250 – Opiate test system, 91 – Toxicology

B. Date Summary Prepared

September 16, 2021

C. Description of Device

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-touse liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in

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urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine samplefor a fixed amount of specific antibody binding sites. In the presence of free drug fromthe sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The assay consists of reagents (A and E).

Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative.

Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

D. Intended Use

The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer.

The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

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CharacteristicsCandidate Device: DRICocaine Metabolite AssayPredicate Device: DRI CocaineMetabolite Assay(K181499)
Intended UseThe Alinity c Cocaine assay is ahomogeneous enzyme immunoassayintended for the qualitative and/orsemi-quantitative determination ofbenzoylecgonine (CocaineMetabolite) in human urine at acutoff concentration of either 150ng/mL or 300 ng/mL on the Alinity canalyzer.The semiquantitative application isfor the purpose of enablinglaboratories to determine anappropriate dilution of the specimenfor confirmation by a confirmatorymethod such as LiquidChromatography/Tandem MassSpectrometry (LC-MS/MS) orpermitting laboratories to establishquality control procedures.The assay provides only apreliminary analytical test result. Amore specific alternative chemicalmethod must be used to obtain aconfirmed analytical result. GasChromatography/Mass Spectrometry(GC/MS) or LiquidChromatography/Tandem MassSpectrometry (LC-MS/MS) are thepreferred confirmatory method. Testsfor cocaine metabolite cannotdistinguish between abused drugsand certain prescribed medications.Clinical and professional judgmentshould be applied to any drug ofabuse test result, particularly whenpreliminary results are used. For InVitro Diagnostic Use Only.The DRI Cocaine Metabolite EnzymeImmunoassay is a homogeneousenzyme immunoassay intended forthe qualitative and/or semi-quantitative determination ofbenzoylecgonine (CocaineMetabolite) in human urine at acutoff concentration of either 150ng/mL or 300 ng/mL.The semi-quantitative mode is for thepurpose of enabling laboratories todetermine an appropriate dilution ofthe specimen for confirmation by aconfirmatory method such as LiquidChromatography/tandem massspectrometry (LC-MS/MS) orpermitting laboratories to establishquality control procedures.The assay provides only apreliminary analytical test result. Amore specific alternative chemicalmethod must be used to obtain aconfirmed analytical result. Gaschromatography / Mass spectrometry(GC/MS) or Liquidchromatography/tandem massspectrometry (LC-MS/MS) is thepreferred confirmatory method. Testsfor cocaine metabolite cannotdistinguish between abused drugs andcertain prescribed medications.Clinical and professional judgmentshould be applied to any drug ofabuse test result, particularly whenpreliminary results are used. For InVitro Diagnostic Use Only.
CharacteristicsCandidate Device: DRI CocaineMetabolite AssayPredicate Device: DRI CocaineMetabolite Assay(K181499)
OperatingPrinciple(Technology)DRISame
Measured AnalyteBenzoylecgonineSame
Test MatrixUrineSame
Cut-off Levels150 ng/mL and 300 ng/mLSame
MethodologyHomogeneous EnzymeImmunoassaySame
Reagents FormLiquid ready-to-use.Same
AntibodyMouse monoclonal antibodiesSame
Storage2–8 °C until expiration date.Same
Principal OperatorTrained professionalsSame
Calibrator Levelsfor Semi-Quant5-point Calibrator5-point Calibrator
ReferenceInstrumentAlinity c Analyzer SystemBeckman Coulter AU680 ClinicalChemistry Analyzer

E. Comparison to Predicate Device

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F. Test Principle

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowingthe drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. Theenzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

G. Summary of Supporting Data

1. Analytical Performance:

Performance is evaluated on the Alinity c Analyzer System.

a) Precision

Precision studies were performed in accordance with CLSI Guideline EP05-A3. Samples were prepared by spiking Benzoylecgonine (Cocaine Metabolite) into drug free urine at the cutoff, 25%, 50%, 75% and 100% above and below the cutoff and tested in both qualitative and semi-quantitative

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modes. Results presented below were generated by testing all samples in replicates of 3, twice per day for20 days, total n=120. The results for both cutoffs are summarized in the tables below:

Spiked Concentration(ng/mL)% of Cutoff(150 ng/mL)Total Precision (n=120)
# ofDeterminantsImmunoassay Results(Negative/Positive)
0-100%119119/0
37.5-75%120120/0
75-50%120120/0
112.5-25%120120/0
150100%12076/44
187.5+25%1200/120
225+50%1200/120
262.5+75%1200/120
300+100%1200/120

Qualitative Study Analysis for 150 ng/mL cutoff

Qualitative Study Analysis for 300 ng/mL cutoff

Spiked Concentration(ng/mL)% of Cutoff(300 ng/mL)Total Precision (n=120)
# ofDeterminantsImmunoassay Results(Negative/Positive)
0-100%119119/0
75-75%120120/0
150-50%120120/0
225-25%120120/0
300100%12044/76
375+25%1200/120
450+50%1200/120
525+75%1200/120
600+100%1200/120

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Spiked Concentration(ng/mL)% of Cutoff(150 ng/mL)Total Precision (n=120)
# of DeterminantsImmunoassay Results(Negative/Positive)
0-100%119119/0
37.5-75%120120/0
75-50%120120/0
112.5-25%120120/0
150100%12073/47
187.5+25%1200/120
225+50%1200/120
262.5+75%1200/120
300+100%1190/119

Semi-Quantitative Study Analysis for 150 ng/mL cutoff

Semi-Quantitative Study Analysis for 300 ng/mL cutoff

Spiked Concentration(ng/mL)% of Cutoff(300ng/mL)# of DeterminantsTotal Precision (n=120)Immunoassay Results(Negative/Positive)
0-100%119119/0
75-75%120120/0
150-50%120120/0
225-25%120120/0
300100%11942/77
375+25%1200/120
450+50%1200/120
525+75%1200/120
600+100%1200/120

b) Spike Recovery

The study was performed for at least 21 replicates. This study was carried out by testing spiked samples containing Benzoylecgonine (Cocaine Metabolite) at the cutoff calibrator and control levels. The spiked samples were prepared by spiking Benzoylecgonine (Cocaine Metabolite) into drug free urine. Samples were tested in both qualitative and semi-quantitative mode. The qualitative results for both cutoffs are summarized in the tables below.

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Replicates112.5 ng/mL(n=25)187.5 ng/mL(n=25)
1NegativePositive
2NegativePositive
3NegativePositive
4NegativePositive
5NegativePositive
6NegativePositive
7NegativePositive
8NegativePositive
9NegativePositive
10NegativePositive
11NegativePositive
12NegativePositive
13NegativePositive
14NegativePositive
15NegativePositive
16NegativePositive
17NegativePositive
18NegativePositive
19NegativePositive
20NegativePositive
21NegativePositive
22NegativePositive
23NegativePositive
24NegativePositive
25NegativePositive
OverlapNoNo
Relative to C/OAll 25 below C/OAll 25 above C/O

Qualitative Data for 150 ng/mL cutoff

Qualitative Data for 300 ng/mL cutoff

Replicates225 ng/mL(n=25)375 ng/mL(n=25)
1NegativePositive
2NegativePositive
3NegativePositive
4NegativePositive
5NegativePositive
6NegativePositive
7NegativePositive
8NegativePositive
9NegativePositive
10NegativePositive

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Replicates225 ng/mL(n=25)375 ng/mL(n=25)
11NegativePositive
12NegativePositive
13NegativePositive
14NegativePositive
15NegativePositive
16NegativePositive
17NegativePositive
18NegativePositive
19NegativePositive
20NegativePositive
21NegativePositive
22NegativePositive
23NegativePositive
24NegativePositive
25NegativePositive
OverlapNoNo
Relative to C/OAll 25 below C/OAll 25 above C/O

c) Analytical Recovery and Linearity

Linearity studies were performed in accordance with CLSI Guideline EP06-A. To demonstrate the dilution linearity for purposes of sample dilution and quality control of the entire assay range, drug free urine was spiked to the high level calibrator using Benzoylecgonine (Cocaine Metabolite) (1000 ng/mL) and diluted with drug free urine to generate 9 intermediate levels.

Each sample was run in replicates of five in semi-quantitative mode and the average was used to determine percent recovery compared to the expected target value. The percent recovery is summarized in the table below:

LevelExpectedConcentration(ng/mL)Observed MeanConcentration(ng/mL)Recovery (%)
10.00.0N/A
2103.298.895.7
3206.4230.1111.4
4309.7344.3111.2
5412.9428.8103.9
6516.1502.297.3
7619.3655.3105.8
8722.6757.2104.8
9825.8892.0108.0
10929.0922.399.3
111032.21032.2100.0

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d) Method Comparison and Accuracy

The method comparison study was performed in accordance with CLSI Guideline CLSIEP09c 3rd Edition. At least one hundred patient samples were analyzed by the DRI Cocaine Metabolite Assay in both qualitative and semi-quantitative modes and the results were compared to LC-MS/MS. The qualitative and semi-quantitative results for both cutoffs are summarized in the tables below:

Semi-Quantitative Mode Accuracy study with LC-MS/MS as reference method for 150ng/mL cutoff

CandidateDevice ResultsNegativebyLC-MS/MS< 50% of Cutoffconcentration byLC-MS/MS (< 75ng/mL)Near CutoffNegative (Between50% below thecutoff and thecutoff concentrationas determined byLC-MS/MS) (75-149 ng/mL)Near Cutoff Positive(Betweenthe cutoffand 50% above thecutoff concentrationas determined byLC-MS/MS) (150-225 ng/mL)High Positives(Greater than 50%above cutoffconcentration (>225 ng/mL)
Positive001546
Negative1233400

Agreement among Positives: 51/51 = 100% Agreement among Negative: 49/50 = 98%

One result was found to be discordant, where the specimen had an interpretation of positive with the DRI Cocaine Metabolite Assay and an interpretation of negative with LC-MS/MS. The discordant results are provided below:

Sample IDDRI Cocaine Metabolite AssayLC-MS/MS
InterpretationBenzoylecgonine Concentration(ng/mL)
CEA00125Positive134

Semi-Quantitative Mode Accuracy study with LC-MS/MS as reference method for 300ng/mL cutoff

CandidateDevice ResultsNegativeby LC-MS/MS< 50% of Cutoffconcentration byLC-MS/MS (<150 ng/mL)Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration asdetermined byLC-MS/MS) (150-299 ng/mL)Near CutoffPositive (Betweenthe cutoff and 50%above the cutoffconcentration asdetermined byLC-MS/MS) (300-450 ng/mL)High Positives(Greater than50% abovecutoffconcentration (>450 ng/mL) )
Positive002941
Negative1233300

Agreement among Positives: 50/50 = 100%

Agreement among Negative: 48/50 = 96%

Two results were found to be discordant, where the specimens had an interpretation of positive with the DRI Cocaine Metabolite Assay (Alinity c Cocaine assay) and an interpretation of

{12}------------------------------------------------

DRI Cocaine Metabolite AssayLC-MS/MS
Sample IDInterpretationBenzoylecgonine Concentration(ng/mL)
CEA00028Positive268
CEA00124Positive211

negative with LC-MS/MS. The discordant results are provided below:

Qualitative Accuracy study with LC-MS/MS as reference method for 150 ng/mL cutoff

CandidateDevice ResultsNegativeby LC-MS/MS< 50% of Cutoffconcentration byLC-MS/MS (<75 ng/mL)Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration asdetermined byLC-MS/MS)(75 - 149 ng/mL)Near CutoffPositive (Betweenthe cutoff and 50%above the cutoffconcentration asdetermined byLC-MS/MS) (150-225 ng/mL)High Positives(Greater than50% abovecutoffconcentration (>225 ng/mL)
Positive001546
Negative1233400

Agreement among Positives: 51/51 = 100% Agreement among Negative: 49/50 = 98%

One result was found to be discordant, where the specimen had an interpretation of positive with the DRI Cocaine Metabolite Assay and an interpretation of negative with LC-MS/MS. The discordant results are provided below:

DRI Cocaine Metabolite AssayLC-MS/MS
Sample IDInterpretationBenzoylecgonine Concentration(ng/mL)
CEA00125Positive134

Qualitative Accuracy study with LC-MS/MS as reference method for 300 ng/mL cutoff

CandidateDevice ResultsNegativebyLC-MS/MS< 50% of Cutoffconcentration byLC-MS/MS (<150 ng/mL)Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration asdetermined byLC-MS/MS)(150-299ng/mL)Near CutoffPositive (Betweenthe cutoff and50% above thecutoffconcentration asdetermined byLC-MS/MS)(300-450 ng/mL)High Positives(Greater than50% above cutoffconcentration (>450 ng/mL)
Positive002941
Negative1233300

Agreement among Positives: 50/50 = 100%

Agreement among Negative: 48/50 = 96%

Two results were found to be discordant, where the specimens had an interpretation of positive with the DRI Cocaine Metabolite Assay and an interpretation of negative with LC-MS/MS. The discordant results are provided below:

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Sample IDDRI Cocaine Metabolite AssayInterpretationLC-MS/MSBenzoylecgonine Concentration(ng/mL)
CEA00028Positive268
CEA00124Positive211

e) Specificity

The cross-reactivity of Cocaine and its metabolites were evaluated by adding known amounts of each compound to drug-free negative urine. The results are summarized inthe tables below:

Cocaine and metabolitesTested Concentration(ng/mL)Cross-reactivity(%)
Benzoylecgonine150100
Cocaine25,0000.6
Cocaethylene30,0000.5
Ecgonine90,0000.17
Ecgonine Methyl Ester100,000<0.15
m-hydroxybenzoylecgonine30050
Norcocaine100,000<0.15

Cross reactivity of Cocaine and its metabolites for 150 ng/mL cut off

Cross reactivity of Cocaine and its metabolites for 300 ng/mL cut-off

Cocaine and metabolitesTested Concentration(ng/mL)Cross-reactivity(%)
Benzoylecgonine300100
Cocaine50,0000.6
Cocaethylene60,0000.5
Ecgonine160,0000.19
Ecgonine Methyl Ester100,000<0.3
m-hydroxybenzoylecgonine60050
Norcocaine100,000<0.3

Structurally unrelated compounds were evaluated by adding each substance to Benzoylecgonine spiked at 112.5 ng/mL (-25% of the 150 ng/mL cutoff concentration), 187.5 ng/mL (+25% of the 150 ng/mL cutoff concentration), 225 ng/mL (-25% of the 300 ng/mLcutoff concentration) and 375 ng/mL (+25% of the 300 ng/mL cutoff concentration), at theconcentrations indicated. As shown in the table below, the controls were detected accurately, low control as negative and the high control as positive, indicating that all the compounds evaluated exhibited no significant cross-reactivity at the concentrations tested.

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Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
11-nor-Δ9 -THC-COOH100,000NegativePositive
1R,2S(-)-Ephedrine100,000NegativePositive
1S,2R(+)-Ephedrine100,000NegativePositive
Acetaminophen1,000,000NegativePositive
Acetylsalicylic acid1,000,000NegativePositive
Acyclovir75,000NegativePositive
Albuterol1,000,000NegativePositive
Amikacin1,000,000NegativePositive
Amitriptyline100,000NegativePositive
Amobarbital100,000NegativePositive
Amoxicillin1,000,000NegativePositive
Amphetamine1,000,000NegativePositive
Azithromycin75,000NegativePositive
Benzocaine1,000,000NegativePositive
Buprenorphine100,000NegativePositive
Bupropion100,000NegativePositive
Caffeine100,000NegativePositive
Calcium Carbonate5,000,000NegativePositive
Carbamazepine100,000NegativePositive
Carisoprodol100,000NegativePositive
Chlorpromazine500,000NegativePositive
Chlorzoxazone1,000,000NegativePositive
cis-Tramadol1,000,000NegativePositive
Clomipramine100,000NegativePositive
Clonidine100,000NegativePositive
Codeine1,000,000NegativePositive
Cotinine100,000NegativePositive
Dapsone100,000NegativePositive
Desipramine100,000NegativePositive
Dextromethorphan100,000NegativePositive
Dihydrocodeine100,000NegativePositive
Diphenhydramine1,000,000NegativePositive
Doxepine500,000NegativePositive
Doxycycline Hyclate100,000NegativePositive
EDDP100,000NegativePositive
Ethyl β-D-glucuronide100,000NegativePositive
Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
Fentanyl100,000NegativePositive
Fluconazole100,000NegativePositive
Fluoxetine50,000NegativePositive
Gabapentin100,000NegativePositive
Gentamicin100,000NegativePositive
Haloperidol100,000NegativePositive
Heroin100,000NegativePositive
Hydrocodone100,000NegativePositive
Hydromorphone100,000NegativePositive
Hydroxyzine100,000NegativePositive
Hyoscyamine HCl75,000NegativePositive
Ibuprofen5,000,000NegativePositive
Imipramine100,000NegativePositive
Indomethacin75,000NegativePositive
Lamotrigine1,000,000NegativePositive
Levofloxacin75,000NegativePositive
Lidocaine1,000,000NegativePositive
Lithium heparin5,000,000NegativePositive
Loratadine500,000NegativePositive
LSD100,000NegativePositive
Maprotiline100,000NegativePositive
Meperidine1,000,000NegativePositive
Mesoridazine1,000,000NegativePositive

Structurally unrelated compounds spiked at the concentration listed below into Low and High control urine for 150 ng/mL cut-off

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Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
Methadone1,000,000NegativePositive
Methamphetamine100,000NegativePositive
Methylphenidate100,000NegativePositive
Metoclopramide1,000,000NegativePositive
Metronidazole100,000NegativePositive
Morphine200,000NegativePositive
Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
Morphine-3B-D-glucuronide100,000NegativePositive
Morphine-6β-D-glucuronide100,000NegativePositive
Nalbuphine1,000,000NegativePositive
Nalorphine100,000NegativePositive
Naloxone100,000NegativePositive
Naltrexone1,000,000NegativePositive
Naproxen5,000,000NegativePositive
Nitrazepam100,000NegativePositive
Norbuprenorphine100,000NegativePositive
Norcodeine100,000NegativePositive
Nordiazepam100,000NegativePositive
Norfluoxetine HCl1,000,000NegativePositive
Norketamine100,000NegativePositive
Norproxyphene100,000NegativePositive
Nortriptyline100,000NegativePositive
Ofloxacin100,000NegativePositive
Omeprazole75,000NegativePositive
Oxazepam1,000,000NegativePositive
Oxycodone100,000NegativePositive
Oxymorphone100,000NegativePositive
Paroxetine100,000NegativePositive
PCP1,000,000NegativePositive
Phenelzine75,000NegativePositive
Phenobarbital1,000,000NegativePositive
Promethazine100,000NegativePositive
Propoxyphene750,000NegativePositive
Ranitidine100,000NegativePositive
Risperidone100,000NegativePositive
Scopolamine1,000,000NegativePositive
Secobarbital1,000,000NegativePositive
Sertraline100,000NegativePositive
Spironolactone750,000NegativePositive
Stavudine100,000NegativePositive
Tapentadol100,000NegativePositive
Terbinafine750,000NegativePositive
Thiopental1,000,000NegativePositive
Thioridazine750,000NegativePositive
Tobramycin1,000,000NegativePositive
Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
Tolmetin750,000NegativePositive
Trazodone1,000,000NegativePositive
Trimethoprim1,000,000NegativePositive
Vancomycin1,000,000NegativePositive
Venlafaxine1,000,000NegativePositive
Verapamil100,000NegativePositive
Zolpidem Tartrate100,000NegativePositive

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{17}------------------------------------------------

Structurally unrelated compounds spiked at the concentration listed below into Low and High control urine for 300 ng/mL cut-off

Spiked Benzoylecgonine Level
Low Control-25% of cutoff(112.5 ng/mL)High Control+25% of cutoff(112.5 ng/mL)
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Positive/NegativePositive/Negative
11-nor-A9-THC-COOH100,000NegativePositive
1R,2S(-)-Ephedrine100,000NegativePositive
1S,2R(+)-Ephedrine100,000NegativePositive
Acetaminophen1,000,000NegativePositive
Acetylsalicylic acid1,000,000NegativePositive
Acyclovir75,000NegativePositive
Albuterol1,000,000NegativePositive
Amikacin1,000,000NegativePositive
Amitriptyline100,000NegativePositive
Amobarbital100,000NegativePositive
Amoxicillin1,000,000NegativePositive
Amphetamine1,000,000NegativePositive
Azithromycin75,000NegativePositive
Benzocaine1,000,000NegativePositive
Buprenorphine100,000NegativePositive
Bupropion100,000NegativePositive
Caffeine100,000NegativePositive
Calcium Carbonate5,000,000NegativePositive
Carbamazepine100,000NegativePositive
Carisoprodol100,000NegativePositive
Chlorpromazine500,000NegativePositive
Spiked Benzoylecgonine Level
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Low Control-25% of cutoff(112.5 ng/mL)Positive/NegativeHigh Control+25% of cutoff(112.5 ng/mL)Positive/Negative
Chlorzoxazone1,000,000NegativePositive
cis-Tramadol1,000,000NegativePositive
Clomipramine100,000NegativePositive
Clonidine100,000NegativePositive
Codeine1,000,000NegativePositive
Cotinine100,000NegativePositive
Dapsone100,000NegativePositive
Desipramine100,000NegativePositive
Dextromethorphan100,000NegativePositive
Dihydrocodeine100,000NegativePositive
Diphenhydramine1,000,000NegativePositive
Doxepine500,000NegativePositive
Doxycycline Hyclate100,000NegativePositive
EDDP100,000NegativePositive
Ethyl β-D-glucuronide100,000NegativePositive
Fentanyl100,000NegativePositive
Fluconazole100,000NegativePositive
Fluoxetine50,000NegativePositive
Gabapentin100,000NegativePositive
Gentamicin100,000NegativePositive
Haloperidol100,000NegativePositive
Heroin100,000NegativePositive
Hydrocodone100,000NegativePositive
Hydromorphone100,000NegativePositive
Hydroxyzine100,000NegativePositive
Hyoscyamine HCl75,000NegativePositive
Ibuprofen5,000,000NegativePositive
Imipramine100,000NegativePositive
Indomethacin75,000NegativePositive
Lamotrigine1,000,000NegativePositive
Levofloxacin75,000NegativePositive
Lidocaine1,000,000NegativePositive
Lithium heparin5,000,000NegativePositive
Loratadine500,000NegativePositive
LSD100,000NegativePositive
Maprotiline100,000NegativePositive
Meperidine1,000,000NegativePositive
Mesoridazine1,000,000NegativePositive
Spiked Benzoylecgonine Level
Low ControlHigh Control
-25% of cutoff+25% of cutoff
(112.5 ng/mL)(112.5 ng/mL)
Structurally UnrelatedCompoundsTestedConcentration(ng/mL)Positive/NegativePositive/Negative
Methadone1,000,000NegativePositive
Methamphetamine100,000NegativePositive
Methylphenidate100,000NegativePositive
Metoclopramide1,000,000NegativePositive
Metronidazole100,000NegativePositive
Morphine200,000NegativePositive
Morphine-3β-D-glucuronide100,000NegativePositive
Morphine-6β-D-glucuronide100,000NegativePositive
Nalbuphine1,000,000NegativePositive
Nalorphine100,000NegativePositive
Naloxone100,000NegativePositive
Naltrexone1,000,000NegativePositive
Naproxen5,000,000NegativePositive
Nitrazepam100,000NegativePositive
Norbuprenorphine100,000NegativePositive
Norcodeine100,000NegativePositive
Nordiazepam100,000NegativePositive
Norfluoxetine HCl1,000,000NegativePositive
Norketamine100,000NegativePositive
Norproxyphene100,000NegativePositive
Nortriptyline100,000NegativePositive
Ofloxacin100,000NegativePositive
Omeprazole75,000NegativePositive
Oxazepam1,000,000NegativePositive
Oxycodone100,000NegativePositive
Oxymorphone100,000NegativePositive
Paroxetine100,000NegativePositive
PCP1,000,000NegativePositive
Phenelzine75,000NegativePositive
Phenobarbital1,000,000NegativePositive
Promethazine100,000NegativePositive
Propoxyphene750,000NegativePositive
Ranitidine100,000NegativePositive
Structurally UnrelatedCompoundsTested Concentration (ng/mL)Spiked Benzoylecgonine Level
Low Control -25% of cutoff (112.5 ng/mL) Positive/NegativeHigh Control +25% of cutoff (112.5 ng/mL) Positive/Negative
Risperidone100,000NegativePositive
Scopolamine1,000,000NegativePositive
Secobarbital1,000,000NegativePositive
Sertraline100,000NegativePositive
Spironolactone750,000NegativePositive
Stavudine100,000NegativePositive
Tapentadol100,000NegativePositive
Terbinafine750,000NegativePositive
Thiopental1,000,000NegativePositive
Thioridazine750,000NegativePositive
Tobramycin1,000,000NegativePositive
Tolmetin750,000NegativePositive
Trazodone1,000,000NegativePositive
Trimethoprim1,000,000NegativePositive
Vancomycin1,000,000NegativePositive
Venlafaxine1,000,000NegativePositive
Verapamil100,000NegativePositive
Zolpidem Tartrate100,000NegativePositive

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{19}------------------------------------------------

{20}------------------------------------------------

f) Interference

The interference studies were performed in accordance with CLSI Guideline EP07- A3, using both qualitative and semi-quantitative modes. The potential interference of pH, endogenous and exogenous physiologic substances on recovery of Benzoylecgonine using DRI Cocaine Metabolite Assay was assessed by spiking known compounds of potentially interfering substances into the low control, 112.5 ng/mL (-25% of the cutoff concentration of 150 ng/mL) and 225 ng/mL (-25% of the cutoff concentration of 300 ng/mL) and high control, 187.5 ng/mL (+25% of the cutoff concentration of 150 ng/mL) and 375 ng/mL (+25% of the cutoff concentration of 300 ng/mL). In the presence of the compounds listed below, the controls were detected accurately, indicating that these compounds did not show interference in the assay.

{21}------------------------------------------------

CompoundTested Concentration(mg/dL)Spiked Benzoylecgonine Level
Low Control-25% of cutoff(112.5 ng/mL)High Control+25% of cutoff(187.5 ng/mL)
Acetaminophen10NegativePositive
Acetone1000NegativePositive
Ascorbic Acid1000NegativePositive
Aspirin10NegativePositive
Caffeine10NegativePositive
Creatinine500NegativePositive
Ethanol1000NegativePositive
Galactose10NegativePositive
y -Globulin500NegativePositive
Glucose3000NegativePositive
Hemoglobin150NegativePositive
Human Serum Albumin500NegativePositive
Ibuprofen10NegativePositive
Oxalic Acid100NegativePositive
Riboflavin7.5NegativePositive
Sodium Chloride1000NegativePositive
Urea1250NegativePositive
pH
pH3NegativePositive
pH4NegativePositive
pH5NegativePositive
pH6NegativePositive
pH7NegativePositive
pH8NegativePositive
pH9NegativePositive
pH10NegativePositive
pH11NegativePositive

Interference substances for 150 ng/mL cut-off

{22}------------------------------------------------

CompoundTested Concentration(mg/dL)Spiked Benzoylecgonine Level
Low Control-25% of cutoff(225 ng/mL)High Control+25% of cutoff(375 ng/mL)
Acetaminophen10NegativePositive
Acetone1000NegativePositive
Ascorbic Acid1000NegativePositive
Aspirin10NegativePositive
Caffeine10NegativePositive
Creatinine500NegativePositive
Ethanol1000NegativePositive
Galactose10NegativePositive
y-Globulin500NegativePositive
Glucose3000NegativePositive
Hemoglobin150NegativePositive
Human Serum Albumin500NegativePositive
Ibuprofen10NegativePositive
Oxalic Acid100NegativePositive
Riboflavin7.5NegativePositive
Sodium Chloride1000NegativePositive
Urea1250NegativePositive
pH
pH3NegativePositive
pH4NegativePositive
pH5NegativePositive
pH6NegativePositive
pH7NegativePositive
pH8NegativePositive
pH9NegativePositive
pH10NegativePositive
pH11NegativePositive

Interference substances for 300 ng/mL cut-off

g) Specific Gravity

Drug free urine samples with specific gravity ranging in value within 1.004 to 1.029 were split and spiked with Benzoylecgonine to a final concentration of either 112.5 ng/mL or 225 ng/mL (the low control concentrations) or 187.5 ng/mL or 375 ng/mL (high control concentrations). These samples were then evaluated in both qualitative and semi-quantitative modes. The controls were detected accurately, indicating that no interference was observed.

{23}------------------------------------------------

Specific GravitySpiked Benzoylecgonine Level
Low ControlHigh Control
1.004NegativePositive
1.005NegativePositive
1.007NegativePositive
1.010NegativePositive
1.011NegativePositive
1.013NegativePositive
1.019NegativePositive
1.023NegativePositive
1.025NegativePositive
1.029NegativePositive

Specific gravity interference data for 150 ng/mL cut-off

Specific gravity interference data for 300 ng/mL cut-off

Specific GravitySpiked Benzoylecgonine Level
Low ControlHigh Control
1.004NegativePositive
1.005NegativePositive
1.007NegativePositive
1.010NegativePositive
1.011NegativePositive
1.013NegativePositive
1.019NegativePositive
1.023NegativePositive
1.025NegativePositive
1.029NegativePositive

H. Conclusion

The information supports a determination of substantial equivalence between DRI Cocaine Metabolite Assay and the predicate device DRI Cocaine Metabolite Assay (K181499).

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).