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K Number
K150275
Device Name
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
Manufacturer
Immunalysis Corporation
Date Cleared
2015-03-09

(33 days)

Product Code
DJGDIFDKB
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only. The Immunalysis 6-Acetylmorphine 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. Gas Chromatography/ Mass Spectrometry (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. Immunalysis 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay. Immunalysis 6-Acetylmorphine Urine Calibrator: The Immunalysis 6-Acetylmorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to 6-Acetylmorphine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes 6-AcetyImorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative. Calibrator and controls are sold separately. Reagents are liquid, ready to use The 6-AcetyImorphine calibrator and controls consist of a cutoff calibrator at 10ng/mL, a LOW control at 7.5ng/mL for the 10ng/mL cutoff and a HIGH control at 12.5ng/mL for the 10ng/mL cutoff.
More Information

K102779

Not Found

No
The description details a standard enzyme immunoassay for detecting a specific substance in urine. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis relies on chemical reactions and automated clinical chemistry analyzers, not data-driven algorithms.

No

This device is an in-vitro diagnostic device used to detect 6-Acetylmorphine in urine, not to treat a medical condition.

Yes
The document explicitly states that the device is an "in-vitro diagnostic device".

No

The device is an in-vitro diagnostic device consisting of chemical reagents (antibody/substrate and enzyme conjugate) and control/calibrator materials, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in-vitro diagnostic device is for prescription use only."
  • Nature of the Test: The device performs a qualitative analysis of 6-Acetylmorphine in human urine using an enzyme immunoassay. This is a laboratory test performed on a biological sample (urine) to detect a substance (6-Acetylmorphine) that indicates a physiological state (presence of the drug). This aligns with the definition of an in vitro diagnostic test.
  • Use in Laboratories: The intended use specifies "for use in laboratories," which is a common setting for IVD testing.
  • Calibrators and Controls: The description of the calibrator and controls further supports its use as an IVD, as these are essential components for ensuring the accuracy and reliability of diagnostic tests.

N/A

Intended Use / Indications for Use

The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only.

The Immunalysis 6-Acetylmorphine 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. Gas Chromatography/ Mass Spectrometry (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.

Immunalysis 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay.

Immunalysis 6-Acetylmorphine Urine Calibrator: The Immunalysis 6-Acetylmorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.

Product codes (comma separated list FDA assigned to the subject device)

DJG, DKB, DIF

Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to 6-Acetylmorphine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes 6-AcetyImorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative. Calibrator and controls are sold separately. Reagents are liquid, ready to use

The 6-AcetyImorphine calibrator and controls consist of a cutoff calibrator at 10ng/mL, a LOW control at 7.5ng/mL for the 10ng/mL cutoff and a HIGH control at 12.5ng/mL for the 10ng/mL cutoff.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  1. Precision/Cutoff Characterization Study:
    • Study Type: Precision/Cutoff Characterization
    • Sample Size: 80 determinations (20 days, 2 runs per day in duplicate)
    • Key Results: Verified that the cutoff serves as a boundary between negative and positive interpretations and that the device produces consistent values during repeated measurements.
      • At -100% to -25% of cutoff (0 to 7.5 ng/mL), all 80 determinations were Negative.
      • At cutoff (10 ng/mL), 43 were Negative and 37 were Positive.
      • At +25% to +100% of cutoff (12.5 to 20 ng/mL), all 80 determinations were Positive.
  2. Specificity and Cross-Reactivity:
    • Study Type: Specificity and Cross-Reactivity
    • Key Results: Evaluated structurally similar compounds. 6-Acetylmorphine showed 100% cross-reactivity. Other compounds showed varying degrees of cross-reactivity or none.
  3. Interference:
    • Study Type: Interference (Structurally non-similar compounds, endogenous compounds, effect of pH, effect of specific gravity)
    • Key Results:
      • Structurally Non-Similar Compounds: Most tested compounds did not show interference at -25% and +25% of the cutoff.
      • Endogenous Compounds: Ascorbic Acid showed interference (Negative result at +25% cutoff). Sodium Chloride showed interference (Negative result at +25% cutoff).
      • Boric Acid: Showed interference (Negative result at +25% cutoff).
      • Effect of pH: pH 3.0 showed interference (Negative result at +25% cutoff). Other pH values (4.0-11.0) did not show interference.
      • Effect of Specific Gravity: No interference observed across various specific gravity values.
      • Summary of Interferences: Ascorbic acid, sodium chloride, boric acid, and pH of 3 are considered interferences.
  4. Method Comparison:
    • Study Type: Method Comparison
    • Sample Size: Unspecified number of unaltered, anonymous, and discarded clinical urine samples.
    • Key Results: Comparison with LC/MS Confirmation showed 100% agreement.
      • Test Device (+) confirmed by LC/MS (+): 40 samples.
      • Test Device (-) confirmed by LC/MS (-): 40 samples.
      • Qualitative/Positive: 4 samples in 10-15 ng/mL range, 36 samples >15 ng/mL (100% agreement).
      • Qualitative/Negative: 36 samples

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

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

IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR. POMONA CA 91767

March 9, 2015

Re: K150275

Trade/Device Name: Immunalysis 6-acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-acetylmorphine Urine Calibrator, Immunalysis 6-acetylmorphine Urine Controls

Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKB, DIF Dated: January 20, 2015 Received: February 4, 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 (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Katherine Serrano -A

For : 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

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Indications for Use

510(k) Number (if known) K150275

Device Name

Immunalysis 6-Acetylmorphine Urine Enzyme Immunalysis 6-Acetylmorphine Urine Controls and Immunalysis 6-Acetylmorphine Urine Calibrator

Indications for Use (Describe)

The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is callbrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only.

The Immunalysis 6-Acetylmorphine 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. Gas Chromatography/ Mass Spectrometry (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.

Immunalysis 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay.

Immunalysis 6-Acetylmorphine Urine Calibrator: The Immunalysis 6-Acetylmorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.

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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A. Contact Information

510(k) SUMMARY (K150275)

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

    1. Manufacturer: Immunalysis Corporation 2. Contact Name: Joseph Ginete Regulatory Affairs Specialist 3. Contact Title: 4. Address: 829 Towne Center Drive Pomona, CA 91767 (909) 482-0840 5. Phone: (909) 482-0850 6. Fax: 7. Email: iginete@immunalysis.com 8. Summary prepared on: March 6, 2015 B. Device Information 1. Trade Name: Immunalysis 6-AcetyImorphine Urine Enzyme Immunoassay Immunalysis 6-AcetyImorphine Urine Controls Immunalysis 6-Acetylmorphine Urine Calibrator 2. Common Name: Immunalysis 6-AcetyImorphine Urine Enzyme Immunoassay Immunalysis 6-AcetyImorphine Urine Controls Immunalysis 6-AcetyImorphine Urine Calibrator 3. Device Classification: II 4. Regulation Number: 21 CFR 862.3650 Opiate Test System 21 CFR 862.3200 Clinical Toxicology Calibrator 21 CFR 862.3280 Clinical Toxicology Control Material 5. Panel: Toxicology(91) 6. Product Code: DJG DKB DIF C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
      1. Predicate Device: Emit® II Plus 6-AcetyImorphine Assay Emit® II Plus 6-AM/ Ecstasy Calibrators Emit® II Plus 6-AM/ Ecstasy Controls 2. Predicate Company: Siemens Healthcare Diagnostics Inc. 3. Predicate K Number: K102779

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D. Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to 6-Acetylmorphine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes 6-AcetyImorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative. Calibrator and controls are sold separately. Reagents are liquid, ready to use

The 6-AcetyImorphine calibrator and controls consist of a cutoff calibrator at 10ng/mL, a LOW control at 7.5ng/mL for the 10ng/mL cutoff and a HIGH control at 12.5ng/mL for the 10ng/mL cutoff.

  • E. Intended Use
    The Immunalysis 6-AcetyImorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only.

The Immunalysis 6-Acetylmorphine 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 Liguid 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.

lmmunalysis 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay.

Immunalysis 6-AcetyImorphine Urine Calibrator: The Immunalysis 6-AcetyImorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.

6-Acetylmorphine Assay K102779Immunalysis 6-Acetylmorphine Urine EIA
Intended UseThe qualitative analysis of 6-
Acetylmorphine in human urine with
automated clinical chemistry
analyzersSame
Type of ProductAnalytical ReagentsSame
Measured Analytes6-AcetylmorphineSame
Test MatrixUrineSame
Cutoff Levels10ng/mL of 6-AcetylmorphineSame
Test SystemHomogeneous Enzyme
ImmunoassaySame
MaterialsLiquid Ready-to-Use R1 Reagent
and Lyophilized R2 ReagentLiquid Ready-to-Use Antibody/Substrate
Reagents and Liquid Ready-to-Use Enzyme
Labeled Conjugate
  • F. Comparison of the new device with the predicate device

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6-Acetylmorphine Assay K102779Immunalysis 6-Acetylmorphine Urine ElA
Mass Spectroscopy
ConfirmationRequired for preliminary positive
analytical resultsSame
AntibodyMouse monoclonal antibody to 6-
AcetylmorphineRecombinant antibody to 6-Acetylmorphine
Storage2 – 8°C until expiration dateSame
Calibrator FormLiquidSame
Calibrator LevelFour (4) Levels (5, 10, 15 and 20
ng/mL)One (1) Level (10ng/mL)
Control LevelsTwo (2) Levels (7.5 and 12.5ng/mL)Same
  • G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay to the predicate
      1. Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was Beckman Coulter AU 400e. y table of the Qualitativ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table 1. Qualitative Analysis (for 10ng/mL cutoff)
The following is a summary table of the Qualitative Analysis for the 10ng/mL cutoff test data results.
Table 1 - Qualitative Analysis (for 10ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
2.5-75%8080 Negative
5-50%8080 Negative
7.5-25%8080 Negative
10Cutoff8043 Neg / 37 Pos
12.5+25%8080 Positive
15+50%8080 Positive
17.5+75%8080 Positive
20+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 cutoff. The instrument used for this test was a Beckman Coulter AU 400e.
      The qualitative result summary table for the 10ng/mL cutoff is outlined below:
Table 2 - Structurally Related Compounds (for 10 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
6-Acetylmorphine10Positive100
6-Acetylcodeine600Positive1.7
Buprenorphine1,000,000NegativeN.D.
Codeine1,000,000NegativeN.D.
Dextromethorphan1,000,000NegativeN.D.
Dihydrocodeine1,000,000NegativeN.D.

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Table 2 - Structurally Related Compounds (for 10 ng/mL cutoff) - Qualitative
Ethylmorphine1,000,000NegativeN.D.
Heroin1,375Positive0.7
Hydrocodone1,000,000NegativeN.D.
Hydromorphone325,000Positive0.003
Imipramine1,000,000NegativeN.D.
Levorphanol1,000,000NegativeN.D.
Meperidine1,000,000NegativeN.D.
Morphine285,000Positive0.000035
Morphine 3-D-glucuronide1,000,000NegativeN.D.
Morphine 6-D-glucuronide1,000,000NegativeN.D.
Nalorphine80,000Positive0.0125
Naloxone300,000Positive0.00333
Naltrexone390,000Positive0.00256
Naproxen1,000,000NegativeN.D.
Norbuprenorphine100,000NegativeN.D.
Norcodeine1,000,000NegativeN.D.
Normorphine250,000Positive0.004
Oxycodone1,000,000NegativeN.D.
Oxymorphone360,000Positive0.00277
  1. Interference - Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. The instrument used for this test was a Beckman Coulter AU 400e. a. The following is a summary table of the structurally non-similar
compounds for the 10ng/mL cutoff :
Table 3 - Structurally Non-Similar Compounds (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-25% Cutoff (7.5ng/mL)
ResultInterference?+25% Cutoff (12.5ng/mL)
ResultInterference?
4-Bromo-2,5,Dimethoxyphenethylamine100,000NegativeNoPositiveNo
Acetaminophen500,000NegativeNoPositiveNo
Acetylsalicyclic Acid500,000NegativeNoPositiveNo
Alprazolam100,000NegativeNoPositiveNo
7-Aminoclonazepam100,000NegativeNoPositiveNo
7-Aminoflurnitrazepam100,000NegativeNoPositiveNo
7-Aminonitrazepam100,000NegativeNoPositiveNo
Amitriptyline100,000NegativeNoPositiveNo
Amobarbital100,000NegativeNoPositiveNo
S-(+) Amphetamine100,000NegativeNoPositiveNo
Benzoylecgonine500,000NegativeNoPositiveNo
Benzylpiperazine100,000NegativeNoPositiveNo
Bromazepam100,000NegativeNoPositiveNo
Bupropion100,000NegativeNoPositiveNo
Butabarbital100,000NegativeNoPositiveNo
Butalbital100,000NegativeNoPositiveNo
Caffeine500,000NegativeNoPositiveNo
Carbamazepine100,000NegativeNoPositiveNo
Chlorpromazine100,000NegativeNoPositiveNo
cis Tramadol100,000NegativeNoPositiveNo
Table 3 - Structurally Non-Similar Compounds (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
ResultInterference?ResultInterference?
Clobazam100,000NegativeNoPositiveNo
Clomipramine100,000NegativeNoPositiveNo
Clonazepam100,000NegativeNoPositiveNo
Cannabidiol100,000NegativeNoPositiveNo
Cannabinol100,000NegativeNoPositiveNo
Carisoprodol100,000NegativeNoPositiveNo
Chlordiazepoxide100,000NegativeNoPositiveNo
Cocaine100,000NegativeNoPositiveNo
Cotinine100,000NegativeNoPositiveNo
Cyclobenzaprine100,000NegativeNoPositiveNo
Digoxin100,000NegativeNoPositiveNo
Desalkyflurazepam100,000NegativeNoPositiveNo
Dehydronorketamine50,000NegativeNoPositiveNo
Demoxepam100,000NegativeNoPositiveNo
Delta-9-THC100,000NegativeNoPositiveNo
Desipramine100,000NegativeNoPositiveNo
N-desmethyltapentadol100,000NegativeNoPositiveNo
Diazepam100,000NegativeNoPositiveNo
Diphenhydramine500,000NegativeNoPositiveNo
Doxepin100,000NegativeNoPositiveNo
Ecgonine100,000NegativeNoPositiveNo
Ecgonine methyl ester100,000NegativeNoPositiveNo
EDDP100,000NegativeNoPositiveNo
1R,2S(-)-Ephedrine100,000NegativeNoPositiveNo
1S,2R(+)-Ephedrine100,000NegativeNoPositiveNo
Ethyl glucuronide100,000NegativeNoPositiveNo
Fenfluramine100,000NegativeNoPositiveNo
Fentanyl100,000NegativeNoPositiveNo
Flunitrazepam100,000NegativeNoPositiveNo
Fluoxetine100,000NegativeNoPositiveNo
Flurazepam100,000NegativeNoPositiveNo
Haloperidol100,000NegativeNoPositiveNo
Hexobarbital100,000NegativeNoPositiveNo
11-hydroxy-delta-9-THC100,000NegativeNoPositiveNo
Ibuprofen500,000NegativeNoPositiveNo
Ketamine100,000NegativeNoPositiveNo
Lamotrignine100,000NegativeNoPositiveNo
Lidocaine100,000NegativeNoPositiveNo
Lorazepam100,000NegativeNoPositiveNo
Lorazepam Glucuronide50,000NegativeNoPositiveNo
Lormetazepam100,000NegativeNoPositiveNo
LSD100,000NegativeNoPositiveNo
Maprotiline100,000NegativeNoPositiveNo
(+)-MDA100,000NegativeNoPositiveNo
MDEA100,000NegativeNoPositiveNo
MDMA100,000NegativeNoPositiveNo
Meprobamate100,000NegativeNoPositiveNo
Methadone100,000NegativeNoPositiveNo
S(+)-Methamphetamine100,000NegativeNoPositiveNo
Methaquolone100,000NegativeNoPositiveNo
Methoxetamine100,000NegativeNoPositiveNo
Methylphenidate100,000NegativeNoPositiveNo
Midazolam100,000NegativeNoPositiveNo

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Table 3 - Structurally Non-Similar Compounds (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
ResultInterference?ResultInterference?
Nitrazepam100,000NegativeNoPositiveNo
Nordiazepam100,000NegativeNoPositiveNo
Norketamine100,000NegativeNoPositiveNo
Norpropoxyphene100,000NegativeNoPositiveNo
Norpseudoephedrine100,000NegativeNoPositiveNo
Nortriptyline100,000NegativeNoPositiveNo
Oxazepam100,000NegativeNoPositiveNo
Oxazepam glucuronide100,000NegativeNoPositiveNo
PCP100,000NegativeNoPositiveNo
Pentazocine100,000NegativeNoPositiveNo
Phentermine100,000NegativeNoPositiveNo
Pentobarbital100,000NegativeNoPositiveNo
Phenobarbital100,000NegativeNoPositiveNo
Phenylephedrine100,000NegativeNoPositiveNo
Phenylpropanolamine100,000NegativeNoPositiveNo
Phenytoin100,000NegativeNoPositiveNo
PMA100,000NegativeNoPositiveNo
Prazepam100,000NegativeNoPositiveNo
Proproxyphene100,000NegativeNoPositiveNo
Propranolol100,000NegativeNoPositiveNo
Protriptyline100,000NegativeNoPositiveNo
R,R(-)-Pseudoephedrine100,000NegativeNoPositiveNo
S,S(+)-Pseudoephedrine100,000NegativeNoPositiveNo
Ranitidine100,000NegativeNoPositiveNo
Ritalinic Acid100,000NegativeNoPositiveNo
Salicylic Acid100,000NegativeNoPositiveNo
Secobarbital100,000NegativeNoPositiveNo
Sertraline100,000NegativeNoPositiveNo
Sufentanil Citrate50,000NegativeNoPositiveNo
11-nor-9 carboxy THC100,000NegativeNoPositiveNo
Temazepam100,000NegativeNoPositiveNo
Theophylline100,000NegativeNoPositiveNo
Thioridazine100,000NegativeNoPositiveNo
Triazolam100,000NegativeNoPositiveNo
Trifluoromethylphenyl-piperazine100,000NegativeNoPositiveNo
Trimipramine100,000NegativeNoPositiveNo
Trazodone100,000NegativeNoPositiveNo
Verapamil100,000NegativeNoPositiveNo
Venlafaxine100,000NegativeNoPositiveNo
Zolpidem Tartrate100,000NegativeNoPositiveNo

b. The following is a summary table of the endogenous compounds results for the 10ng/mL cutoff:

Table 4 - Endogenous Compounds (for 10ng/mL cutoff)
Concentration-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
CompoundTested (ng/mL)ResultInterference?ResultInterference?
Acetone1.0 g/dLNegativeNoPositiveNo
Ascorbic Acid1.5 g/dLNegativeNoNegativeYes
Bilirubin0.002 g/dLNegativeNoPositiveNo
Creatinine0.5 g/dLNegativeNoPositiveNo
Ethanol1.0 g/dLNegativeNoPositiveNo
Galactose0.01 g/dLNegativeNoPositiveNo
y-Globulin0.5 g/dLNegativeNoPositiveNo

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Table 4 - Endogenous Compounds (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
ResultInterference?ResultInterference?
Glucose2.0 g/dLNegativeNoPositiveNo
Hemoglobin0.115 g/dLNegativeNoPositiveNo
Human Serum Albumin0.5 g/dLNegativeNoPositiveNo
Oxalic Acid0.1 g/dLNegativeNoPositiveNo
Riboflavin0.0075 g/dLNegativeNoPositiveNo
Sodium Azide1% w/vNegativeNoPositiveNo
Sodium Chloride6.0 g/dLNegativeNoNegativeYes
Sodium Fluoride1% w/vNegativeNoPositiveNo
Urea6.0 g/dLNegativeNoPositiveNo

c. The following is a summary table of the additional ascorbic acid and sodium chloride testing at ±50% of the cutoff:

Table 5 - Endogenous Compounds (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-50% Cutoff (5ng/mL)+50% Cutoff (15ng/mL)
ResultInterference?ResultInterference?
Ascorbic Acid1.5 g/dLNegativeNoNegativeYes
Sodium Chloride6.0 g/dLNegativeNoPositiveNo

d. The following is a summary table of Boric Acid for the 10ng/mL cutoff results:

Table 6 - Boric Acid (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
Boric Acid1% w/vResultInterference?ResultInterference?
NegativeNoNegativeYes

e. The following is a summary table of the additional boric acid testing at +50% of the cutoff:

Table 7 - Boric Acid (for 10ng/mL cutoff)
CompoundConcentration
Tested (ng/mL)-50% Cutoff (5ng/mL)+50% Cutoff (15ng/mL)
ResultInterference?ResultInterference?
Boric Acid1% w/vNegativeNoNegativeYes

f. The following is a summary table of the effect of pH results for the 10ng/mL cutoff:

Table 8 - Effect of pH (for 10ng/mL cutoff)
Test ParameterValue-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
ResultInterference?ResultInterference?
pH3.0NegativeNoNegativeYes
pH4.0NegativeNoPositiveNo
pH5.0NegativeNoPositiveNo
pH6.0NegativeNoPositiveNo
pH7.0NegativeNoPositiveNo
pH8.0NegativeNoPositiveNo
pH9.0NegativeNoPositiveNo
pH10.0NegativeNoPositiveNo
pH11.0NegativeNoPositiveNo

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Table 9 - Effect of pH (for 10ng/mL cutoff)
Test ParameterValue-50% Cutoff (5ng/mL)+50% Cutoff (15ng/mL)
ResultInterference?ResultInterference?
pH3.0NegativeNoPositiveNo
  • g. The following is a summary table of the additional pH 3.0 testing at ±50%
  • h. The following is a summary table of the effect of specific gravity results for 10ng/mL cutoff:
Table 10 - Effect of Specific Gravity (for 10ng/mL cutoff)
Test ParameterValue-25% Cutoff (7.5ng/mL)+25% Cutoff (12.5ng/mL)
Specific Gravity1.000ResultInterference?ResultInterference?
Specific Gravity1.000NegativeNoPositiveNo
Specific Gravity1.002NegativeNoPositiveNo
Specific Gravity1.005NegativeNoPositiveNo
Specific Gravity1.010NegativeNoPositiveNo
Specific Gravity1.015NegativeNoPositiveNo
Specific Gravity1.020NegativeNoPositiveNo
Specific Gravity1.025NegativeNoPositiveNo
Specific Gravity1.030NegativeNoPositiveNo
  • i. Ascorbic acid, sodium chloride, boric acid and pH of 3 are considered interferences
    1. Method Comparison Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
    • a. The following is a comparison table of qualitative assay performance for the 10ng/mL cutoff:

Table 11 - Method Comparison (for 10ng/mL cutoff) - Qualitative

LC/MS Confirmation
(+)(-)
Test Device(+)400
(-)040
  • b. The following is a summary table of qualitative assay performance for the 10ng/mL cutoff:
Type6-Acetylmorphine ConcentrationAgreement (%)
15 ng/mL
Qualitative/ Positive00436100
Qualitative/ Negative36400100
    1. Stability -
      A closed accelerated stability study was performed on reagents, calibrator and controls at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for reagents. This stability study supported an initial expiration date of 12 months for calibrator and controls. The instrument used for this test was a Beckman Coulter AU 400e. Real stability studies are ongoing.
    1. Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution.
    1. Calibrator and Control Stability An open accelerated stability study was performed at 25°C to establish the initial open vial expiration dating. The stability

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study supported an initial open vial expiration date of 12 months. The instrument used for this test was a Beckman Coulter AU 400e. All calibrator level(s) (10ng/mL) and control level(s) (7.5ng/mL and 12.5ng/mL) were within specifications for Day 0, 2, 8, 16, 24, 30, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.

  • Calibrator and Control Value Assignment calibrator and controls are 8. manufactured and are tested by mass spectrometry. If any of the analytes are out of the acceptable range, then the calibrator and control is adjusted and retested. Values are assigned to the calibrator and controls once the mass spectrometry results are within the acceptable ranges.
  • H. Conclusion

The information provided in this pre-market notification demonstrates that the Immunalysis 6-AcetyImorphine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.