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K Number
K153693
Device Name
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Manufacturer
IMMUNALYSIS CORPORATION
Date Cleared
2016-03-18

(86 days)

Product Code
LAF,DKB,DKZ
Regulation Number
862.3610
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
K093114,K051088
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of 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 permitting laboratories to establish quality control procedures.
The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.

Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles.

AI/ML Overview

Here's an analysis of the provided text regarding the Immunalysis Methamphetamine Urine Enzyme Immunoassay and its performance, structured according to your request:

Device: Immunalysis Methamphetamine Urine Enzyme Immunoassay & Immunalysis Multi-Drug Calibrators
Intended Use: Qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers at dual cutoffs of 500ng/mL and 1000ng/mL. For prescription use.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantitative target alongside its performance study results. Instead, the studies demonstrate the device's performance, implying that these results meet implicit acceptance criteria for substantial equivalence to the predicate device. For the purpose of this table, I will infer the acceptance criteria from the observed performance and the nature of these types of immunoassays (i.e., that they should accurately classify samples around the cutoff and show no significant interference).

Performance Study CategoryImplicit Acceptance Criteria (Inferred)Reported Device Performance (as presented in the document)
1. Precision/Cutoff CharacterizationAll determinations at concentrations ≥+25% of cutoff should be positive; all determinations at concentrations ≤-25% of cutoff should be negative. ~50% positive/negative at cutoff.500ng/mL qualitative: < -25% (0-375ng/mL) = 80/80 Negative; +25% (625-1000ng/mL) = 80/80 Positive; Cutoff (500ng/mL) = 41 Negative/39 Positive. 1000ng/mL qualitative: < -25% (0-750ng/mL) = 80/80 Negative; +25% (1250-2000ng/mL) = 80/80 Positive; Cutoff (1000ng/mL) = 44 Negative/36 Positive. 500ng/mL semi-quantitative: < -25% (0-375ng/mL) = 80/80 Negative; +25% (625-1000ng/mL) = 80/80 Positive; Cutoff (500ng/mL) = 35 Negative/45 Positive. 1000ng/mL semi-quantitative: < -25% (0-750ng/mL) = 80/80 Negative; +25% (1250-2000ng/mL) = 80/80 Positive; Cutoff (1000ng/mL) = 37 Negative/43 Positive.
2. Specificity/Cross-ReactivityNo significant cross-reactivity with structurally similar compounds at concentrations below the established cutoffs for Methamphetamine. Must accurately detect Methamphetamine.Demonstrated various levels of cross-reactivity with structurally similar compounds (e.g., MDMA 62.50% at 500ng/mL cutoff, 71.43% at 1000ng/mL cutoff for equal concentration). (+) Methamphetamine showed 100% cross-reactivity at the respective cutoff concentrations. (-) Methamphetamine and Amphetamines showed low cross-reactivity (e.g., 0.06% to 2.50%).
3. Non-Similar Compound InterferenceNo interference (false positives or negatives) with structurally unrelated compounds at high concentrations.Tested 50+ structurally unrelated compounds at 100,000 ng/mL. All results were Negative at -25% cutoff concentration of methamphetamine, and Positive at +25% cutoff concentration of methamphetamine, for both qualitative and semi-quantitative modes at both 500ng/mL and 1000ng/mL cutoffs (indicating no interference).
4. Endogenous Compound InterferenceNo interference from common endogenous compounds (e.g., acetone, bilirubin, glucose).Tested 14 common endogenous compounds. All results were Negative at -25% cutoff concentration of methamphetamine, and Positive at +25% cutoff concentration of methamphetamine, for both qualitative and semi-quantitative modes at both 500ng/mL and 1000ng/mL cutoffs (indicating no interference).
5. Boric Acid InterferenceNo interference from Boric Acid, specifically.At 1% w/v Boric Acid, results were Negative for both -25% and +25% of cutoff in qualitative mode, and Negative for -25% but Positive for +25% in semi-quantitative mode (1000ng/mL cutoff). Note: The table for +25% cutoff (500ng/mL) showed 'Negative' for qualitative and semi-quantitative, which is an unexpected result if the system is truly meant to detect positive drugs at +25% cutoff. This suggests an interaction that could be considered interference.
6. pH InterferenceNo interference across a physiological and extended pH range (3.0-11.0).For both cutoffs (500ng/mL and 1000ng/mL), all results were Negative at -25% cutoff and Positive at +25% cutoff across the pH range of 3.0-11.0, indicating no interference.
7. Specific Gravity InterferenceNo interference across a physiological range of specific gravity (1.000-1.030).For both cutoffs (500ng/mL and 1000ng/mL), all results were Negative at -25% cutoff and Positive at +25% cutoff across the specific gravity range of 1.000-1.030, indicating no interference.
8. Linearity/RecoveryRecovery within a reasonable range (e.g., 80-120%) across the reportable range.Recovery ranged from 101.2% to 136.4% for concentrations from 200ng/mL to 2200ng/mL.
9. Method Comparison (Clinical Samples)High agreement (e.g., >95%) with LC/MS confirmation for both positive and negative samples at both cutoffs.Qualitative (500ng/mL): 100% agreement (40 Pos, 40 Neg) with LC/MS. Qualitative (1000ng/mL): 100% agreement (40 Pos, 40 Neg) with LC/MS. Semi-quantitative (500ng/mL): 98% positive agreement (40/41 total positive by LC/MS), 100% negative agreement (39/39 total negative by LC/MS). One discordant result. Semi-quantitative (1000ng/mL): 100% positive agreement (39/39 total positive by LC/MS), 98% negative agreement (40/41 total negative by LC/MS). One discordant result. One discordant sample at 500ng/mL cutoff (device positive, LC/MS 494ng/mL - close to cutoff). One discordant sample at 1000ng/mL cutoff (device negative, LC/MS 1017ng/mL - close to cutoff).

2. Sample Size Used for the Test Set and Data Provenance

  • Precision/Cutoff Characterization (Tables 3-6):

    • Test set size: 80 determinations at each of 9 concentration levels per cutoff (0, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). This means 80 samples were prepared at each concentration level. The study was performed for 20 days, 2 runs per day in duplicate.
    • Data Provenance: Drug-free urine spiked with methamphetamine. This is prospective data (laboratory prepared). The country of origin is not explicitly stated but implies a US-based laboratory testing context (given the FDA submission).

  • Specificity and Cross-Reactivity (Tables 7-10) and Interference (Tables 11-18) including pH and Specific Gravity:

    • Test set size: Not explicitly stated as a count of individual samples for each compound, but results are given for individual compounds at specific concentrations. The implication from the precision study (80 determinations per concentration) might suggest similar rigorous testing for these as well, but it's not confirmed. The overall approach is that each compound was "spiked into drug free urine."
    • Data Provenance: Drug-free urine spiked with relevant compounds. This is prospective (laboratory prepared).

  • Method Comparison (Tables 24-33):

    • Test set size: 80 human urine samples (referred to as "clinical urine samples").
    • Data Provenance: "Eighty unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This indicates retrospective data from clinical settings. The country of origin for these samples is not explicitly stated but is implied to be within the US given the context of FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

  • For the Precision/Cutoff Characterization, Specificity/Cross-Reactivity, and Interference studies, the ground truth was established by laboratory spiking of known concentrations of methamphetamine or other compounds into drug-free urine. No human experts were required to establish this ground truth. The spiked concentrations were "confirmed by mass spectrometry (MS)."
  • For the Method Comparison study, the ground truth was established by Mass Spectrometry (LC-MS/MS), which is the "preferred confirmatory method" as stated in the Indications for Use. This is an objective analytical method, not reliant on human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the analytical studies was established by spiking known concentrations (laboratory-prepared) and confirmed by Mass Spectrometry (objective analytical method), not by human adjudication of qualitative results.

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

Not applicable. This device is an in-vitro diagnostic immunoassay for detecting substances in urine, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study related to human improvement with AI assistance is not relevant or described.

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

Yes, this entire study represents a standalone "algorithm only" (device only) performance evaluation. The Immunalysis Methamphetamine Urine Enzyme Immunoassay is an automated clinical chemistry analyzer assay, meaning its output is directly read from the analyzer, without human interpretation of raw data for the primary qualitative or semi-quantitative result. The "human-in-the-loop" would be a lab technician running the sample and interpreting the final pass/fail result based on the analyzer's output relative to the cutoff, but the core performance data presented is the device's direct measurement.

7. The Type of Ground Truth Used

  • Precision/Cutoff Characterization, Specificity/Cross-Reactivity, Interference (including pH, specific gravity, Boric Acid): Laboratory-prepared samples with known, spiked concentrations confirmed by Mass Spectrometry (MS).
  • Method Comparison: LC-MS/MS confirmation (Liquid Chromatography / Mass Spectrometry), which is considered the "gold standard" or preferred confirmatory method for drug testing.

8. The Sample Size for the Training Set

The document describes performance studies for the Immunalysis Methamphetamine Urine Enzyme Immunoassay. For an immunoassay of this type, the "training set" doesn't typically refer to a data set used to train a machine learning model. Instead, it refers to the reagents and their formulation which are developed and optimized internally by the manufacturer. The document does not provide details on the development (analogous to 'training') data or processes. The reported studies are validation studies demonstrating the final product's performance.

9. How the Ground Truth for the Training Set Was Established

As explained above, for an immunoassay, the concept of a "training set" and establishing its ground truth in the context of machine learning is not directly applicable. The "ground truth" for the calibrators (part of the device, analogous to some aspects of training or reference) is detailed:

  • Immunalysis Multi-Drug Calibrators: "Calibrators are manufactured and are tested by mass spectrometry."
  • Negative calibrator: "processed, drug free urine matrix... compared to a reference negative standard to ensure that it is free of analyte."
  • Non-zero calibrators: "prepared by spiking a known concentration of oxazepam in the negative calibrator matrix."
  • "If any of the analytes are not of the acceptable range, then the calibrator is adjusted and re-tested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges."

This means the ground truth for the calibrators is established through controlled spiking of known concentrations and verification by mass spectrometry.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2016

IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767

Re: K153693

Trade/Device Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay. Immunalysis Multi-drug Calibrators Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DKB Dated: December 21, 2015 Received: December 23, 2015

Dear Mr. Ginete:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney 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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Indications for Use

510(k) Number (if known)

Device Name

Immunalysis Methamphetamine Urine Enzyme Immunalysis Multi-Drug Calibrators

Indications for Use (Describe)

The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of 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 permitting laboratories to establish quality control procedures.

The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.

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

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

  • A. Contact Information
      1. Manufacturer: Immunalysis Corporation
      1. Contact Name: Joseph Ginete
      1. Contact Title: Regulatory Affairs Specialist II
      1. Address: 829 Towne Center Drive Pomona, CA 91767
      1. Phone: (909) 482-0840
      1. Fax: (909) 482-0850
      1. Email: jginete(@immunalysis.com
      1. Summary prepared on: February 17, 2016
  • B. Device Information
      1. Trade Name: Immunalysis Methamphetamine Urine Enzvme Immunoassay Immunalysis Multi-Drug Calibrators
      1. Common Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators

C. Regulatory Information

    1. Device Classification: II
    1. Regulation Number: 21 CFR 862.3100 Enzyme Immunoassay,

Methamphetamine

21 CFR 862.3200 Clinical Toxicology Calibrator

    1. Panel: Toxicology(91)
    1. Product Code: DKZ

DKB

  • D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
      1. Predicate Device: DRI® Methamphetamines Assay LZI Multiple Analyte Drugs of Abuse Calibrators and Controls
      1. Predicate Company: Microgenics, Inc. Lin-Zhi International, Inc.
      1. Predicate K Number: K093114

K051088

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  • E. Device Description
      1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
      1. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators is summarized as follows:

Table 1 Immunalysis Multi-Drug Calibrators
AnalyteMulti-Drug Calibrators
Level 1Level 2Level 3Level 4
Benzoylecgonine150ng/mL300ng/mL500ng/mL1000ng/mL
Methamphetamine500ng/mL1000ng/mL1500ng/mL2000ng/mL
Morphine100ng/mL300ng/mL500ng/mL1000ng/mL
PCP12.5ng/mL25ng/mL50ng/mL100ng/mL
Oxazepam100ng/mL200ng/mL500ng/mL1000ng/mL

F. Intended Use

  • The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a 1. homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.
    The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical

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consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

    1. Immunalysis Multi-Drug Calibrators
      The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP and Oxazepam. The calibrators are designed for prescription use with immunoassays.

  • G. Comparison of the new device with the predicate device

ItemMethamphetamine Assay K093114Immunalysis Methamphetamine Urine EIA
Intended UseFor the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mLFor the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mL
Type of ProductAnalytical ReagentsAnalytical Reagents
Measured AnalytesMethamphetamine and AmphetamineMethamphetamine
Test MatrixUrineUrine
Cutoff Levels500ng/mL and 1000ng/mL ofMethamphetamine/Amphetamine500ng/mL and 1000ng/mL ofMethamphetamine
Test SystemHomogeneous Enzyme ImmunoassayHomogeneous Enzyme Immunoassay
MaterialsLiquid Ready-to-Use Two ReagentAssay (R1 and R2)Antibody/Substrate Reagents and EnzymeLabeled Conjugate
Mass SpectroscopyConfirmationRequired for preliminary positiveanalytical resultsRequired for preliminary positive analyticalresults
AntibodyMonoclonal antibodies toMethamphetamine and/orAmphetamineMonoclonal antibody to Methamphetamine
Storage2 – 8°C until expiration date2 – 8°C until expiration date
ItemLZI Multiple Analyte K051088Immunalysis Multi-Drug Calibrator
Analytebenzoylecgonine, d-methamphetamine, methadone,morphine, oxazepam,secobarbital, phencyclidine,propoxyphenebenzoylecgonine, methamphetamine,morphine, PCP, oxazepam
MatrixUrineUrine
Calibrator Levels5 Levels – See Table 2 Below5 Levels (Negative and Level 1, 2, 3 and 4) -See Device Description Table 1
Storage2 – 8°C until expiration date2 – 8°C until expiration date

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Table 2 LZI Multiple Analyte DAU Calibrators and Controls
AnalyteMultiple Analyte Calibrators
LowCutoffIntermediateHigh
d-Methamphetamine250ng/mL500ng/mL750ng/mL1000ng/mL
Morphine1000ng/mL2000ng/mL4000ng/mL5000ng/mL
Phencyclidine12.5ng/mL25ng/mL50ng/mL100ng/mL
Benzoylecgonine75ng/mL150ng/mL300ng/mL1000ng/mL
Oxazepam100ng/mL200ng/mL500ng/mL1000ng/mL
Secobarbital100ng/mL200ng/mL500ng/mL1000ng/mL
Propoxyphene150ng/mL300ng/mL600ng/mL1000ng/mL
Methadone150ng/mL300ng/mL600ng/mL1000ng/mL
  • H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Methamphetamine Urine Enzyme Immunoassay to the predicate
      1. Precision/ Cutoff Characterization/ Reproducibility Precision/Cutoff Characterization - Study was performed for 20 days, 2 runs per day in duplicate on drug free urine (N=80) spiked with methamphetamine to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff. The spiked concentrations were confirmed by mass spectrometry (MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e.
a. The following is a summary table of the Qualitative Analysis for the
500ng/mL cutoff test data results.
Table 3 - Qualitative Analysis (for 500ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
125-75%8080 Negative
250-50%8080 Negative
375-25%8080 Negative
500Cutoff8041 Negative/39 Positive
625+25%8080 Positive
750+50%8080 Positive
875+75%8080 Positive
1000+100%8080 Positive

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Table 4 - Qualitative Analysis (for 1000 ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
250-75%8080 Negative
500-50%8080 Negative
750-25%8080 Negative
1000Cutoff8044 Negative/36 Positive
1250+25%8080 Positive
1500+50%8080 Positive
1750+75%8080 Positive
2000+100%8080 Positive
  • b. The following is a summary table of the Qualitative Analysis for the 1000ng/mL cutoff test data results
  • c. The following is a summary table of the Semi-Quantitative Analysis for the 500ng/mL cutoff test data results.
Table 5 - Semi-Quantitative Analysis (for 500ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
125-75%8080 Negative
250-50%8080 Negative
375-25%8080 Negative
500Cutoff8035 Negative/45 Positive
625+25%8080 Positive
750+50%8080 Positive
875+75%8080 Positive
1000+100%8080 Positive
  • d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results.
Table 6 - Semi-Quantitative Analysis (for 1000ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
250-75%8080 Negative
500-50%8080 Negative
750-25%8080 Negative
1000Cutoff8037 Negative/43 Positive
1250+25%8080 Positive
1500+50%8080 Positive
1750+75%8080 Positive
2000+100%8080 Positive
    1. Specificity and Cross-Reactivity Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs, in both the qualitative and semi-

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quantitative modes. The instrument used for this test was a Beckman Coulter AU 400e.

  • a. The qualitative result summary table for the 500ng/mL cutoff is outlined below:
Table 7 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
(+) Methamphetamine500Positive100.00
(-) Methamphetamine90,000Positive0.56
(+) Amphetamine20,000Positive2.50
(-) Amphetamine900,000Positive0.06
Methylenedioxyamphetamine (MDA)18,000Positive2.78
Methoxyamphetamine (PMA)15,000Positive3.33
Methylenedioxymethamphetamine (MDMA)800Positive62.50
MDEA3,000Positive16.67
Fenfluramine7,000Positive7.14
(+) Pseudoephedrine75,000Positive0.67
(-) Pseudoephedrine300,000Positive0.17
(-) Ephedrine65,000Positive0.77
(+) Ephedrine1,000,000Negative<0.05
Phentermine500,000Positive0.10
Tyramine850,000Positive0.06
Phenylephrine800,000Positive0.06
Diphenhydramine1,000,000Negative<0.050
Phenypropanolamine1,000,000Negative<0.05

b. The qualitative result summary table for the 1000ng/mL cutoff is outlined below:

Table 8 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
(+) Methamphetamine1,000Positive100.00
(-) Methamphetamine200,000Positive0.44
(+) Amphetamine60,000Positive2.50
(-) Amphetamine1,000,000Negative<0.10
Methylenedioxyamphetamine (MDA)40,000Positive2.50
Methoxyamphetamine (PMA)40,000Positive3.33
Methylenedioxymethamphetamine (MDMA)1,000Positive71.43
MDEA5,000Positive14.29
Fenfluramine10,000Positive6.06
(+) Pseudoephedrine200,000Positive0.67
(-) Pseudoephedrine1,000,000Positive0.13
(-) Ephedrine200,000Positive0.57
(+) Ephedrine1,000,000Negative<0.10

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Table 8 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
Phentermine1,000,000Negative<0.10
Tyramine1,000,000Negative<0.10
Phenylephrine1,000,000Negative<0.10
Diphenhydramine1,000,000Negative<0.10
Phenypropanolamine1,000,000Negative<0.10

c. The semi-quantitative result summary table for the 500ng/mL cutoff is outlined below:

Table 9 - Structurally Related Compounds (for 500 ng/mL cutoff) – Semi-Quantitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
(+) Methamphetamine500Positive100.00
(-) Methamphetamine90,000Positive0.56
(+) Amphetamine20,000Positive2.50
(-) Amphetamine900,000Positive0.06
Methylenedioxyamphetamine (MDA)18,000Positive2.78
Methoxyamphetamine (PMA)15,000Positive3.33
Methylenedioxymethamphetamine(MDMA)800Positive62.50
MDEA3,000Positive16.67
Fenfluramine7,000Positive7.14
(+) Pseudoephedrine75,000Positive0.67
(-) Pseudoephedrine300,000Positive0.17
(-) Ephedrine65,000Positive0.77
(+) Ephedrine1,000,000Negative<0.05
Phentermine500,000Positive0.10
Tyramine850,000Positive0.06
Phenylephrine800,000Positive0.06
Diphenhydramine1,000,000Negative<0.050
Phenypropanolamine1,000,000Negative<0.05
  • d. The semi-quantitative result summary table for the 1000ng/mL cutoff is outlined below:
Table 10 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
(+) Methamphetamine1,000Positive100.00
(-) Methamphetamine200,000Positive0.44
(+) Amphetamine60,000Negative2.50
(-) Amphetamine1,000,000Positive<0.10
Methylenedioxyamphetamine (MDA)40,000Positive2.50
Methoxyamphetamine (PMA)40,000Positive3.33
Methylenedioxymethamphetamine (MDMA)1,000Positive71.43
MDEA5,000Positive14.29

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Table 10 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
Fenfluramine10,000Positive6.06
(+) Pseudoephedrine200,000Positive0.67
(-) Pseudoephedrine1,000,000Positive0.13
(-) Ephedrine200,000Positive0.57
(+) Ephedrine1,000,000Negative<0.10
Phentermine1,000,000Negative<0.10
Tyramine1,000,000Negative<0.10
Phenylephrine1,000,000Negative<0.10
Diphenhydramine1,000,000Negative<0.10
Phenypropanolamine1,000,000Negative<0.10
    1. Interference Structurally unrelated compounds were evaluated in qualitative and semi-quantitatyive modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds. The instrument used for this test was a Beckman Coulter AU 400e.
      a. The following is a summary table of the structurally unrelated compounds for the 500ng/mL cutoff :
Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff)
CompoundConcentration Tested (ng/mL)-25% Cutoff (375ng/mL)+25% Cutoff (625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
4-Bromo-2,5,Dimethoxyphenethylamine100,000NegativeNegativePositivePositive
6-Acetylmorphine100,000NegativeNegativePositivePositive
7-Aminoclonazepam100,000NegativeNegativePositivePositive
Acetaminophen500,000NegativeNegativePositivePositive
Acetylsalicylic Acid500,000NegativeNegativePositivePositive
Alprazolam100,000NegativeNegativePositivePositive
Amitriptyline100,000NegativeNegativePositivePositive
Amobarbital100,000NegativeNegativePositivePositive
Benzoylecgonine500,000NegativeNegativePositivePositive
Benzylpiperazine100,000NegativeNegativePositivePositive
Bromazepam100,000NegativeNegativePositivePositive
Buprenorphine100,000NegativeNegativePositivePositive
Bupropion100,000NegativeNegativePositivePositive
Butabarbital100,000NegativeNegativePositivePositive
Caffeine500,000NegativeNegativePositivePositive
Carbamazepine100,000NegativeNegativePositivePositive
Chlordiazepoxide100,000NegativeNegativePositivePositive
Chlorpromazine100,000NegativeNegativePositivePositive
cis-Tramadol100,000NegativeNegativePositivePositive
Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff)
-25% Cutoff+25% Cutoff
Concentration(375ng/mL)(625ng/mL)
CompoundTestedSemi-Semi-
(ng/mL)QualitativeQuantitativeQualitativeQuantitative
Clobazam100,000NegativeNegativePositivePositive
Clomipramine100,000NegativeNegativePositivePositive
Clonazepam100,000NegativeNegativePositivePositive
Cocaine100,000NegativeNegativePositivePositive
Codeine100,000NegativeNegativePositivePositive
Cyclobenzaprine100,000NegativeNegativePositivePositive
N-Demethyltapentadol100,000NegativeNegativePositivePositive
Delta-9-THC100,000NegativeNegativePositivePositive
Desipramine100,000NegativeNegativePositivePositive
Dextromethorphan100,000NegativeNegativePositivePositive
Diazepam100,000NegativeNegativePositivePositive
Dihydrocodeine100,000NegativeNegativePositivePositive
Doxepin100,000NegativeNegativePositivePositive
EDDP100,000NegativeNegativePositivePositive
Ethyl ß-D-glucuronide100,000NegativeNegativePositivePositive
Ethylmorphine100,000NegativeNegativePositivePositive
Fentanyl100,000NegativeNegativePositivePositive
Flunitrazepam100,000NegativeNegativePositivePositive
Fluoxetine100,000NegativeNegativePositivePositive
Flurazepam100,000NegativeNegativePositivePositive
Heroin100,000NegativeNegativePositivePositive
Hexobarbital100,000NegativeNegativePositivePositive
Hydrocodone100,000NegativeNegativePositivePositive
Hydromorphone100,000NegativeNegativePositivePositive
11-hydroxy-delta-9-THC100,000NegativeNegativePositivePositive
Ibuprofen100,000NegativeNegativePositivePositive
Imipramine100,000NegativeNegativePositivePositive
Ketamine100,000NegativeNegativePositivePositive
Levorphanol Tartrate100,000NegativeNegativePositivePositive
Lidocaine100,000NegativeNegativePositivePositive
Lorazepam100,000NegativeNegativePositivePositive
LSD100,000NegativeNegativePositivePositive
Maprotiline100,000NegativeNegativePositivePositive
Meperidine100,000NegativeNegativePositivePositive
Meprobamate100,000NegativeNegativePositivePositive
Methadone100,000NegativeNegativePositivePositive
Methaquolone100,000NegativeNegativePositivePositive
Methylphenidate100,000NegativeNegativePositivePositive
Morphine100,000NegativeNegativePositivePositive
Morphine-3ß-glucuronide100,000NegativeNegativePositivePositive
Morphine-6ß-glucuronide100,000NegativeNegativePositivePositive
Nalorphine100,000NegativeNegativePositivePositive
Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff)
-25% Cutoff+25% Cutoff
CompoundConcentration(375ng/mL)(625ng/mL)
TestedQualitativeSemi-QualitativeSemi-
(ng/mL)QuantitativeQuantitative
Naloxone100,000NegativeNegativePositivePositive
Naltrexone100,000NegativeNegativePositivePositive
Nitrazepam100,000NegativeNegativePositivePositive
Norbuprenorphine100,000NegativeNegativePositivePositive
Norcodeine100,000NegativeNegativePositivePositive
Nordiazepam100,000NegativeNegativePositivePositive
Normorphine100,000NegativeNegativePositivePositive
Norpropoxyphene100,000NegativeNegativePositivePositive
Nortriptyline100,000NegativeNegativePositivePositive
Oxazepam100,000NegativeNegativePositivePositive
Oxycodone100,000NegativeNegativePositivePositive
Oxymorphone100,000NegativeNegativePositivePositive
PCP100,000NegativeNegativePositivePositive
Pentazocine100,000NegativeNegativePositivePositive
Pentobarbital100,000NegativeNegativePositivePositive
Phenobarbital100,000NegativeNegativePositivePositive
Phentermine100,000NegativeNegativePositivePositive
Phenytoin100,000NegativeNegativePositivePositive
Prazepam100,000NegativeNegativePositivePositive
Propranolol100,000NegativeNegativePositivePositive
Protriptyline100,000NegativeNegativePositivePositive
Ranitidine100,000NegativeNegativePositivePositive
Ritalinic Acid100,000NegativeNegativePositivePositive
Secobarbital100,000NegativeNegativePositivePositive
Sufentanil Citrate100,000NegativeNegativePositivePositive
Temazepam100,000NegativeNegativePositivePositive
11-nor-9 carboxy THC100,000NegativeNegativePositivePositive
Thioridazine100,000NegativeNegativePositivePositive
Triazolam100,000NegativeNegativePositivePositive
Trifluoromethylphenyl-piperazine100,000NegativeNegativePositivePositive
Trimipramine100,000NegativeNegativePositivePositive
Venlafaxine100,000NegativeNegativePositivePositive

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b. The following is a summary table of the structurally unrelated compounds for the 1,000ng/mL cutoff:

Table 12 - Structurally Non-Similar Compounds (for 1,000ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
4-Bromo-2,5,Dimethoxyphenethylamine100,000NegativeNegativePositivePositive
6-Acetylmorphine100,000NegativeNegativePositivePositive
7-Aminoclonazepam100,000NegativeNegativePositivePositive
Acetaminophen500,000NegativeNegativePositivePositive
Acetylsalicyclic Acid500,000NegativeNegativePositivePositive
Alprazolam100,000NegativeNegativePositivePositive
Amitriptyline100,000NegativeNegativePositivePositive
Amobarbital100,000NegativeNegativePositivePositive
Benzoylecgonine500,000NegativeNegativePositivePositive
Benzylpiperazine100,000NegativeNegativePositivePositive
Bromazepam100,000NegativeNegativePositivePositive
Buprenorphine100,000NegativeNegativePositivePositive
Bupropion100,000NegativeNegativePositivePositive
Butabarbital100,000NegativeNegativePositivePositive
Caffeine500,000NegativeNegativePositivePositive
Carbamazepine100,000NegativeNegativePositivePositive
Chlordiazepoxide100,000NegativeNegativePositivePositive
Chlorpromazine100,000NegativeNegativePositivePositive
cis-Tramadol100,000NegativeNegativePositivePositive
Clobazam100,000NegativeNegativePositivePositive
Clomipramine100,000NegativeNegativePositivePositive
Clonazepam100,000NegativeNegativePositivePositive
Cocaine100,000NegativeNegativePositivePositive
Codeine100,000NegativeNegativePositivePositive
Cyclobenzaprine100,000NegativeNegativePositivePositive
N-Demethyltapentadol100,000NegativeNegativePositivePositive
Delta-9-THC100,000NegativeNegativePositivePositive
Desipramine100,000NegativeNegativePositivePositive
Dextromethorphan100,000NegativeNegativePositivePositive
Diazepam100,000NegativeNegativePositivePositive
Dihydrocodeine100,000NegativeNegativePositivePositive
Doxepin100,000NegativeNegativePositivePositive
EDDP100,000NegativeNegativePositivePositive
Ethyl β-D-glucuronide100,000NegativeNegativePositivePositive
Ethylmorphine100,000NegativeNegativePositivePositive
Fentanyl100,000NegativeNegativePositivePositive
Flunitrazepam100,000NegativeNegativePositivePositive
Fluoxetine100,000NegativeNegativePositivePositive
CompoundConcentrationTested(ng/mL)-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Flurazepam100,000NegativeNegativePositivePositive
Heroin100,000NegativeNegativePositivePositive
Hexobarbital100,000NegativeNegativePositivePositive
Hydrocodone100,000NegativeNegativePositivePositive
Hydromorphone100,000NegativeNegativePositivePositive
11-hydroxy-delta-9-THC100,000NegativeNegativePositivePositive
Ibuprofen100,000NegativeNegativePositivePositive
Imipramine100,000NegativeNegativePositivePositive
Ketamine100,000NegativeNegativePositivePositive
Levorphanol Tartrate100,000NegativeNegativePositivePositive
Lidocaine100,000NegativeNegativePositivePositive
Lorazepam100,000NegativeNegativePositivePositive
LSD100,000NegativeNegativePositivePositive
Maprotiline100,000NegativeNegativePositivePositive
Meperidine100,000NegativeNegativePositivePositive
Meprobamate100,000NegativeNegativePositivePositive
Methadone100,000NegativeNegativePositivePositive
Methaquolone100,000NegativeNegativePositivePositive
Methylphenidate100,000NegativeNegativePositivePositive
Morphine100,000NegativeNegativePositivePositive
Morphine-3 β-glucuronide100,000NegativeNegativePositivePositive
Morphine-6 β-glucuronide100,000NegativeNegativePositivePositive
Nalorphine100,000NegativeNegativePositivePositive
Naloxone100,000NegativeNegativePositivePositive
Naltrexone100,000NegativeNegativePositivePositive
Nitrazepam100,000NegativeNegativePositivePositive
Norbuprenorphine100,000NegativeNegativePositivePositive
Norcodeine100,000NegativeNegativePositivePositive
Nordiazepam100,000NegativeNegativePositivePositive
Normorphine100,000NegativeNegativePositivePositive
Norpropoxyphene100,000NegativeNegativePositivePositive
Nortriptyline100,000NegativeNegativePositivePositive
Oxazepam100,000NegativeNegativePositivePositive
Oxycodone100,000NegativeNegativePositivePositive
Oxymorphone100,000NegativeNegativePositivePositive
PCP100,000NegativeNegativePositivePositive
Pentazocine100,000NegativeNegativePositivePositive
Pentobarbital100,000NegativeNegativePositivePositive
Phenobarbital100,000NegativeNegativePositivePositive
Phentermine100,000NegativeNegativePositivePositive
Phenytoin100,000NegativeNegativePositivePositive
Prazepam100,000NegativeNegativePositivePositive
Table 12 - Structurally Non-Similar Compounds (for 1,000ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Propranolol100,000NegativeNegativePositivePositive
Protriptyline100,000NegativeNegativePositivePositive
Ranitidine100,000NegativeNegativePositivePositive
Ritalinic Acid100,000NegativeNegativePositivePositive
Secobarbital100,000NegativeNegativePositivePositive
Sufentanil Citrate100,000NegativeNegativePositivePositive
Temazepam100,000NegativeNegativePositivePositive
11-nor-9 carboxy THC100,000NegativeNegativePositivePositive
Thioridazine100,000NegativeNegativePositivePositive
Triazolam100,000NegativeNegativePositivePositive
Trifluoromethylphenyl-piperazine100,000NegativeNegativePositivePositive
Trimipramine100,000NegativeNegativePositivePositive
Venlafaxine100,000NegativeNegativePositivePositive

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  1. Interference - Endogenous compounds were evaluated in qualitative and semiquantitatyive modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by internally existing physiological conditions. The instrument used for this test was a Beckman Coulter AU 400e.
  • a. The following is a summary table of the endogenous compounds results for the 500ng/mL cutoff:
Table 13 - Endogenous Compounds (for 500ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(375ng/mL)+25% Cutoff(625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Acetone1.0 g/dLNegativeNegativePositivePositive
Ascorbic Acid1.5 g/dLNegativeNegativePositivePositive
Bilirubin0.002 g/dLNegativeNegativePositivePositive
Creatinine0.5 g/dLNegativeNegativePositivePositive
Ethanol1.0 g/dLNegativeNegativePositivePositive
Galactose0.01 g/dLNegativeNegativePositivePositive
y-Globulin0.5 g/dLNegativeNegativePositivePositive
Glucose2.0 g/dLNegativeNegativePositivePositive
Hemoglobin0.150 g/dLNegativeNegativePositivePositive
Human Serum Albumin0.5 g/dLNegativeNegativePositivePositive
Oxalic Acid0.1 g/dLNegativeNegativePositivePositive
Riboflavin0.0075 g/dLNegativeNegativePositivePositive
Sodium Azide1% w/vNegativeNegativePositivePositive
Sodium Chloride6.0 g/dLNegativeNegativePositivePositive

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Table 13 - Endogenous Compounds (for 500ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(375ng/mL)+25% Cutoff(625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Sodium Fluoride1% w/v
Urea6.0 g/dLNegativeNegativePositivePositive

b. The following is a summary table of the endogenous compounds results for the 1,000ng/mL cutoff:

Table 14 - Endogenous Compounds (for 500ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(375ng/mL)+25% Cutoff(625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Acetone1.0 g/dLNegativeNegativePositivePositive
Ascorbic Acid1.5 g/dLNegativeNegativePositivePositive
Bilirubin0.002 g/dLNegativeNegativePositivePositive
Creatinine0.5 g/dLNegativeNegativePositivePositive
Ethanol1.0 g/dLNegativeNegativePositivePositive
Galactose0.01 g/dLNegativeNegativePositivePositive
y-Globulin0.5 g/dLNegativeNegativePositivePositive
Glucose2.0 g/dLNegativeNegativePositivePositive
Hemoglobin0.150 g/dLNegativeNegativePositivePositive
Human Serum Albumin0.5 g/dLNegativeNegativePositivePositive
Oxalic Acid0.1 g/dLNegativeNegativePositivePositive
Riboflavin0.0075 g/dLNegativeNegativePositivePositive
Sodium Azide1% w/vNegativeNegativePositivePositive
Sodium Chloride6.0 g/dLNegativeNegativePositivePositive
Sodium Fluoride1% w/vNegativeNegativePositivePositive
Urea6.0 g/dLNegativeNegativePositivePositive
  1. Interference – Boric Acid at a concentration of 1% w/v was evaluated in qualitative and semi-quantitatyive modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% and ±50% of the cutoff. The instrument used for this test was a Beckman Coulter AU 400e.
  • a. The following is a summary table of Boric Acid for the 500ng/mL cutoff results:
Table 15 – Boric Acid (for 500ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(375ng/mL)+25% Cutoff(625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Boric Acid1% w/vNegativeNegativeNegativeNegative

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  • b. The following is a summary table of the Boric Acid for the 1,000ng/mL cutoff results:
Table 16 – Boric Acid (for 1000ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Boric Acid1% w/vNegativeNegativeNegativePositive
  • c. The following is a summary table of the Boric Acid for the 500ng/mL cutoff results:
Table 17 – Boric Acid (for 500ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-50% Cutoff(250ng/mL)+50% Cutoff(750ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Boric Acid1% w/vNegativeNegativeNegativeN/A
  • d. The following is a summary table of the Boric Acid for the 1,000ng/mL cutoff results:
Table 18 – Boric Acid (for 1000ng/mL cutoff)
CompoundConcentrationTested(ng/mL)-50% Cutoff(250ng/mL)+50% Cutoff (750ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Boric Acid1% w/vNegativeNegativeNegativeNegative
  • Interference To evaluate potential interference from the pH of urine, device 6. performance in the qualitative and semi-quantitative modes was tested using a range of urine pH values (3.0, 4.0. 5.0. 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free urine containing methamphetamine at ±25% of the cutoff. No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 for each test mode. The instrument used for this test was a Beckman Coulter AU 400e.
    • a. The following is a summary table of the effect of pH results for the 500ng/mL cutoff:
Table 19 - Effect of pH (for 500ng/mL cutoff)
Test ParameterValue-25% Cutoff (375ng/mL)+25% Cutoff (625ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
pH3.0NegativeNegativePositivePositive
pH4.0NegativeNegativePositivePositive
pH5.0NegativeNegativePositivePositive
pH6.0NegativeNegativePositivePositive
pH7.0NegativeNegativePositivePositive
pH8.0NegativeNegativePositivePositive
pH9.0NegativeNegativePositivePositive

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Table 19 - Effect of pH (for 500ng/mL cutoff)
Test ParameterValue-25% Cutoff+25% Cutoff
(375ng/mL)(625ng/mL)
QualitativeSemi-QualitativeSemi-
QuantitativeQuantitative
pH10.0NegativeNegativePositivePositive
pH11.0NegativeNegativePositivePositive

b. The following is a summary table of the effect of pH results for the 1,000ng/mL cutoff:

Table 20 - Effect of pH (for 1000ng/mL cutoff)
Test ParameterValue-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
QualitativeSemi-QuantitativeQualitativeSemi-Quantitative
pH3.0NegativeNegativePositivePositive
pH4.0NegativeNegativePositivePositive
pH5.0NegativeNegativePositivePositive
pH6.0NegativeNegativePositivePositive
pH7.0NegativeNegativePositivePositive
pH8.0NegativeNegativePositivePositive
pH9.0NegativeNegativePositivePositive
pH10.0NegativeNegativePositivePositive
pH11.0NegativeNegativePositivePositive
    1. Interference To evaluate potential interference from the specific gravity of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of physiologically relevant urine specific gravity values (1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing methamphetamine at ±25% of the cutoff. No positive or negative interference was observed at urine specific gravity values ranging from 1.000 to 1.030 for each test mode.
    • a. The following is a summary table of the effect of specific gravity results for 500ng/mL cutoff:
Table 21 - Effect of Specific Gravity (for 500ng/mL cutoff)
Test ParameterValue-25% Cutoff(375ng/mL)+25% Cutoff
(625ng/mL)
QualitativeSemi-QualitativeSemi-
QuantitativeQuantitative
Specific Gravity1.000NegativeNegativePositivePositive
Specific Gravity1.002NegativeNegativePositivePositive
Specific Gravity1.005NegativeNegativePositivePositive
Specific Gravity1.010NegativeNegativePositivePositive
Specific Gravity1.015NegativeNegativePositivePositive
Specific Gravity1.020NegativeNegativePositivePositive
Specific Gravity1.025NegativeNegativePositivePositive
Specific Gravity1.030NegativeNegativePositivePositive

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-25% Cutoff(750ng/mL)+25% Cutoff(1250ng/mL)
Test ParameterValueQualitativeSemi-QuantitativeQualitativeSemi-Quantitative
Specific Gravity1.000NegativeNegativePositivePositive
Specific Gravity1.002NegativeNegativePositivePositive
Specific Gravity1.005NegativeNegativePositivePositive
Specific Gravity1.010NegativeNegativePositivePositive
Specific Gravity1.015NegativeNegativePositivePositive
Specific Gravity1.020NegativeNegativePositivePositive
Specific Gravity1.025NegativeNegativePositivePositive
Specific Gravity1.030NegativeNegativePositivePositive
  • b. The following is a summery table of the effect of specific gravity results for 1 000ng/mI a
    1. Linearity/ Recovery A linearity study in the semi-quantitative mode was conducted by spiking a drug free urine pool with a high concentration of methamphetamine as a high value specimen. Additional pools were made by serially diluting the high value specimen with drug free urine to achieve concentrations ranging from 200ng/mL to 2200ng/mL. Each pool was tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. The instrument used for this test was a Beckman Coulter AU 400e. a. The following is a summary table of the linearity/recovery:
Table 23 - Linearity/ Recovery
Expected Concentration (ng/mL)Mean Concentration (ng/mL)Recovery (%)
200272.7136.4
400436.8109.2
600674.6112.4
800830.0103.8
10001107.6110.8
12001247.0103.9
14001481.2105.8
16001711.5107.0
18001917.4106.5
20002080.7104.0
22002226.4101.2

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    1. Method Comparison Eighty unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed for methamphetamine with the candidate test device on a Beckman Coulter AU 400e clinical chemitrsy analyzer and verified by Mass Spectrometry (LC-MS/MS). Results were obtained in both qualitative and semi-quantitative modes. The instruments used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometer.
    • a. The following is a comparison table of qualitative assay performance for the 500ng/mL cutoff:

Table 24 - Method Comparison (for 500ng/mL cutoff) - Qualitative

LC/MS Confirmation
(+)(-)
TestDevice(+)400
(-)040

b. The following is a summary table of qualitative assay performance for the 500ng/mL cutoff:

Table 25 - Assay Performance verified by LC/MS – 500ng/mL Cutoff
Type< 250ng/mL250 ~ 499 ng/mL500 ~ 750 ng/mL> 750 ng/mLAgreement (%)
Qualitative/ Positive00436100
Qualitative/ Negative36400100

c. The following is a comparison table of qualitative assay performance for the 1,000ng/mL cutoff:

Table 26 - Method Comparison (for 1000ng/mL cutoff) - Qualitative

LC/MS Confirmation
(+)(-)
TestDevice(+)400
TestDevice(-)040

d. The following is a summary table of qualitative assay performance for the 1,000ng/mL

Table 27 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff
TypeMethamphetamine ConcentrationAgreement(%)
Qualitative/ Positive< 500ng/mL500 ~ 999 ng/mL1000 ~ 1500 ng/mL> 1500 ng/mL100
Qualitative/ Negative36400100
001624

e. The following is a comparison table of semi-quantitative assay performance for the 500ng/mL cutoff:

Table 28 - Method Comparison (for 500ng/mL cutoff) - Semi-Quantitative

LC/MS Confirmation
(+)(-)
TestDevice(+)401
(-)039

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f. The following is a summary table of semi-quantitative assay performance for the 500ng/mL cutoff:

TypeMethamphetamine ConcentrationAgreement(%)
< 250ng/mL250 ~ 499 ng/mL500 ~ 750 ng/mL> 750 ng/mL
Semi-Quantitative/ Positive0143698
Semi-Quantitative / Negative36300100

g. The following is a summary table of semi-quantitative discordant results for the 500ng/mL cutoff:

Sample IDIn-House IDSemi-Quantitative Results 500ng CutoffLC/MS Confirmation
Table 30 - Discordant Result Summary – 500ng/mL Cutoff – Semi-QuantitativeValueResult
358433ZA16559544.9Positive
494

h.The following is a comparison table of semi-quantitative assay performance for the 1,000ng/mL cutoff:

Table 31 - Method Comparison (for 1000ng/mL cutoff) - Semi-Quantitative

LC/MS Confirmation
(+)(-)
TestDevice(+)390
(-)140

i. The following is a summary table of semi-quantitative assay performance for the 1,000ng/mL cutoff:

TypeMethamphetamine ConcentrationAgreement(%)
< 500ng/mL500 ~ 999 ng/mL1000 ~ 1500 ng/mL> 1500 ng/mL
Semi-Quantitative/ Positive00336100
Semi-Quantitative / Negative3641098

j. The following is a summary table of semi-quantitative discordant results for the 1000ng/mL cutoff

Table 33 - Discordant Result Summary – 1000ng/mL Cutoff – Semi-Quantitative
Sample IDIn-House IDSemi-Quantitative Results 1000ng CutoffLC/MS Confirmation
ValueResult
358429ZA16597998.5Negative1017
  1. Immunalysis Multi-Drug Calibrators Analytical Performance
  • a. Traceability all components of the calibrators have been traced to a commercially available methamphetamine solution.
  • b.Closed Vial Stability (Accelerated) A closed vial stability study was performed at 25°C to establish the initial vial expiration dating. All calibrator levels (1, 2, 3, and 4) were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. The stability study supported an initial expiration date of 12 months after testing on LC/MS. Real time stability studies are ongoing.

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  • c. Open Vial Stability An open vial stability study was performed at 5℃ to establish the initial open vial expiration dating on LC/MS. All calibrator levels (1, 2, 3, and 4) were within specifications for Day 0, 19, 26, 33, 41, and 60. This stability study supported an initial open vial expiration date of 60 days.
  • d. Value Assignment Calibrators are manufactured and are tested by mass spectrometry. The negative calibrator is a processed, drug free urine matrix. The standard is compared to a reference negative standard to ensure that it is free of analyte. The non-zero calibrators are prepared by spiking a known concentration of oxazepam in the negative calibrator matrix. If any of the analytes are not of the acceptable range, then the calibrator is adjusted and re-tested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
  • I. Proposed Labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

  • J. Conclusion
    The information provided in this pre-market notification demonstrates that the Immunalysis Methamphetamine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.

§ 862.3610 Methamphetamine test system.

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