LogoFDA 510(k) Search
K Number
K143502
Device Name
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
Manufacturer
IMMUNALYSIS CORPORATION
Date Cleared
2015-05-20

(161 days)

Product Code
DJGDIFDLJ
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. 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 Opiates 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 Opiates Urine Calibrators 300 The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Immunalysis Multi-Drug Controls The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Immunalysis Opiates Urine Calibrators 2000 The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Device Description
The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. All of the Immunalysis Opiates Urine Calibrators 300 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. All of the Immunalysis Multi-Drug Controls 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets. All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.
More Information

K011150, K051088

K011150, K051088

No
The document describes a standard enzyme immunoassay for detecting opiates in urine, along with associated calibrators and controls. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and optical density measurements, not algorithmic learning.

No
This device is an in-vitro diagnostic assay used for the qualitative and semi-quantitative analysis of opiates in human urine. It is used to detect substances, not to treat a condition or disease.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "This in-vitro diagnostic device is for prescription use only." This directly classifies it as a diagnostic device.

No

The device is an in-vitro diagnostic device consisting of reagents (antibody/substrate and enzyme conjugate) and calibrators/controls, which are physical components used in a laboratory setting with automated clinical chemistry analyzers. It is not solely software.

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

The document explicitly states in the "Intended Use / Indications for Use" section:

  • "This in-vitro diagnostic device is for prescription use only."
  • "The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use..."
  • "The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use..."
  • "The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use..."

These statements clearly indicate that the device and its associated components are intended for in vitro diagnostic use.

N/A

Intended Use / Indications for Use

The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. 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 Opiates 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 Opiates Urine Calibrators 300

The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Multi-Drug Controls

The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Opiates Urine Calibrators 2000

The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Product codes

DJG, DLJ, DJE

Device Description

The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.

All of the Immunalysis Opiates Urine Calibrators 300 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.

All of the Immunalysis Multi-Drug Controls 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets.

All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

  1. Precision/Cutoff Characterization Study: Performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. Verified that the cutoff serves as a boundary between negative and positive qualitative results and verified product performance regarding consistency of measurements. Instrument: Beckman Coulter AU 400e. Key results:
    • 300ng/mL cutoff (Qualitative): 80 determinations at each concentration. At 300ng/mL cutoff, 37 Negative/43 Positive.
    • 2000ng/mL cutoff (Qualitative): 80 determinations at each concentration. At 2000ng/mL cutoff, 42 Negative/38 Positive.
    • 300ng/mL cutoff (Semi-Quantitative): 80 determinations at each concentration. At 300ng/mL cutoff, 20 Negative/60 Positive.
    • 2000ng/mL cutoff (Semi-Quantitative): 80 determinations at each concentration. At 2000ng/mL cutoff, 41 Negative/39 Positive.
  2. Specificity and Cross-Reactivity Study: Structurally similar compounds were spiked into drug-free urine at levels that yield a result equivalent to the cutoffs. Verified assay performance relevant to the device's ability to exclusively determine certain drugs. Instrument: Beckman Coulter AU 400e.
  3. Interference Study: Structurally non-similar compounds, endogenous compounds, the effect of pH, and the effect of specific gravity were evaluated by spiking potential interferents into drug-free urine containing morphine at ±25% of the cutoffs. Found that Boric Acid and Riboflavin caused a false negative response at the concentrations tested. Other potential interferents did not affect assay performance. Instrument: Beckman Coulter AU 400e.
  4. Linearity/Recovery Study: A drug-free urine pool was spiked with a high concentration of the target analyte as a high-value specimen. Additional pools were made by serially diluting the high-value specimen. Verified assay linearity in the semi-quantitative mode. Instrument: Beckman Coulter AU 400e.
  5. Method Comparison Study: Unaltered, anonymous, and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. Verified that product performance can be verified by Mass Spectrometry. Instruments: Beckman Coulter AU 400e and Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
    • 300ng/mL cutoff (Qualitative): LC/MS Confirmation, 40 positive, 39 negative from test device. Assay performance showed 98% qualitative positive agreement (> 450 ng/mL) and 100% qualitative negative agreement ( 3000 ng/mL) and 100% qualitative negative agreement ( 450 ng/mL) and 100% semi-quantitative negative agreement ( 3000 ng/mL) and 100% semi-quantitative negative agreement ( 450 ng/mL, 100% agreement for concentrations 3000 ng/mL, 100% agreement for concentrations 450 ng/mL, 100% agreement for concentrations 3000 ng/mL, 100% agreement for concentrations

§ 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).

0

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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

May 20, 2015

Re: K143502

Trade/Device Name: Immunalysis Opiates Urine Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Multi-Drug Controls Immunalysis Opiates Urine Calibrators 2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II

Product Code: DJG, DLJ, DIF Dated: March 26, 2015 Received: March 27, 2015

Dear Mr. Joseph 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

1

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 -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K143502

Device Name

Immunalysis Opiates Urine Enzyme Immunalysis Opiates Urine Calibrators 300, Immunalysis Multi-Drug Controls, and Immunalysis Opiates Urine Calibrators 2000

Indications for Use (Describe)

Immunalysis Opiates Urine Enzyme Immunoassay

The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. 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 Opiates 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 Opiates Urine Calibrators 300

The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Multi-Drug Controls

The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Opiates Urine Calibrators 2000

The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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B.

C.

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
2.Contact Name:Joseph Ginete
3.Contact Title:Regulatory Affairs Specialist II
4.Address:829 Towne Center Drive Pomona, CA 91767
5.Phone:(909) 482-0840
6.Fax:(909) 482-0850
7.Email:jginete@immunalysis.com
8.Summary prepared on:May 18, 2015
Device Information
1.Trade Name:Immunalysis Opiates Urine Enzyme Immunoassay
Immunalysis Opiates Urine Calibrators 300
Immunalysis Multi-Drug Controls
Immunalysis Opiates Urine Calibrators 2000
2.Common Name:Immunalysis Opiates Urine Enzyme Immunoassay
Immunalysis Opiates Urine Calibrators 300
Immunalysis Multi-Drug Controls
Immunalysis Opiates Urine Calibrators 2000
Regulatory Information
1.Device Classification:II
2.Regulation Number:CFR 862.3650 Opiate Test System
CFR 862.3200 Clinical Toxicology Calibrator
CFR 862.3280 Clinical Toxicology Control
Materials
3.Panel:Toxicology(91)
4.Product Code:DJG
DLJ
DJE

5

IMMUNALYSIS

  • D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
1. Predicate Device:DRI® DAU Opiate Assay
LZI Multiple Analyte Urine Drugs of Abuse
Calibrators and Controls
2. Predicate Company:Microgenics
Lin-Zhi International, Inc.
3. Predicate K Number:K011150
K051088

E. Device Description

    1. The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
    1. All of the Immunalysis Opiates Urine Calibrators 300 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in their corresponding calibrators are summarized as follows:
Table 1 Immunalysis Opiates Urine Calibrators 300
AnalyteOpiates Calibrators
Level 1Level 2Level 3Level 4
Morphine100ng/mL300ng/mL500ng/mL1000ng/mL
    1. All of the Immunalysis Multi-Drug Controls 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets. The concentration of drug analyte in their corresponding controls are summarized as follows:

6

Table 2 Immunalysis Multi-Drug Controls 1
AnalyteMulti-Drug Controls
LOW Control 1HIGH Control 1
Benzoylecgonine112.5ng/mL187.5ng/mL
Methadone225ng/mL375ng/mL
Methamphetamine375ng/mL625ng/mL
Morphine225ng/mL375ng/mL
PCP19ng/mL31ng/mL
Secobarbital150ng/mL250ng/mL
Oxazepam150ng/mL250ng/mL
Table 3 Immunalysis Multi-Drug Controls 2
Multi-Drug Controls
AnalyteLOW Control 2HIGH Control 2
Benzoylecgonine225ng/mL375ng/mL
Methamphetamine750ng/mL1250ng/mL
Morphine1500ng/mL2500ng/mL
    1. All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in the corresponding calibrators are summarized as follows:
Table 4 Immunalysis Opiates Urine Calibrators 2000
Opiates Calibrators
AnalyteLevel 1Level 2Level 3Level 4
Morphine1000ng/mL2000ng/mL4000ng/mL6000ng/mL
  • F. Intended Use
    • The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme 1. immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. 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 Opiates 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 consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

7

IMMUNALYSIS

    1. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
      The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

ItemOpiates Assay K011150Immunalysis Opiates Urine EIA
Intended UseFor the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mLFor the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mL
Type of ProductAnalytical ReagentsAnalytical Reagents
Measured
AnalytesOpiatesOpiates
Test MatrixUrineUrine
Cutoff Levels300ng/mL and 2000ng/mL of
Morphine300ng/mL and 2000ng/mL of
Morphine
Test SystemHomogeneous Enzyme
ImmunoassayHomogeneous Enzyme
Immunoassay (EIA)
MaterialsAntibody/Substrate Reagents and
Enzyme Labeled ConjugateAntibody/Substrate Reagents and
Enzyme Labeled Conjugate
Mass
Spectroscopy
ConfirmationRequired for preliminary positive
analytical resultsRequired for preliminary positive
analytical results
AntibodyMonoclonal antibody to OpiatesMonoclonal antibody to Opiates
Storage2 – 8°C until expiration date2 – 8°C until expiration date
  • G. Comparison of the new device with the predicate device

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IMMUNALYSIS

| Item | LZI Multiple Analyte K051088 | Immunalysis Opiates Urine
Calibrators 300 |
|-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Analyte | benzoylecgonine, d-
methamphetamine, methadone,
morphine, oxazepam, secobarbital,
phencyclidine, propoxyphene | Morphine |
| Matrix | Urine | Same |
| Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and
4) - See Device Description Table 1 |
| Storage | 2 – 8°C until expiration date | Same |

ItemLZI Multiple Analyte K051088Immunalysis Multi-Drug Controls
Analytebenzoylecgonine, d-
methamphetamine, methadone,
morphine, oxazepam, secobarbital,
phencyclidine, propoxyphenebenzoylecgonine, methadome,
methamphetamine, morphine, PCP,
secobarbital, oxazepam
MatrixUrineUrine
Control Levels2 Levels – See Table 5 Below4 Levels (LOW Control 1, HIGH
Control 1, LOW Control 2 and HIGH
Control 2) – See Device Description
Table 2 and Table 3
Storage2 – 8°C until expiration date2 – 8°C until expiration date

| Item | LZI Multiple Analyte K051088 | Immunalysis Opiates Urine
Calibrators 2000 |
|-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Analyte | benzoylecgonine, d-
methamphetamine, methadone,
morphine, oxazepam, secobarbital,
phencyclidine, propoxyphene | Morphine |
| Matrix | Urine | Same |
| Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and
4) - See Device Description Table 4 |
| Storage | 2 - 8°C until expiration date | Same |

Table 5 LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls
AnalyteMultiple Analyte CalibratorsMultiple Analyte Controls
LowCutoffIntermediateHighLevel 1Level 2
d-Methamphetamine250ng/mL500ng/mL750ng/mL1000ng/mL375ng/mL625ng/mL
Morphine1000ng/mL2000ng/mL4000ng/mL6000ng/mL1500ng/mL2500ng/mL
Phencyclidine12.5ng/mL25ng/mL50ng/mL100ng/mL18ng/mL35ng/mL
Benzoylecgonine75ng/mL150ng/mL300ng/mL1000ng/mL110ng/mL190ng/mL
Oxazepam100ng/mL200ng/mL500ng/mL1000ng/mL100ng/mL300ng/mL
Secobarbital100ng/mL200ng/mL500ng/mL1000ng/mL100ng/mL300ng/mL
Propoxyphene150ng/mL300ng/mL600ng/mL1000ng/mL225ng/mL375ng/mL
Methadone150ng/mL300ng/mL600ng/mL1000ng/mL225ng/mL375ng/mL

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  • H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Opiates 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 the product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was a Beckman Coulter AU 400e.
a. The following is a summary table of the Qualitative Analysis for the
300ng/mL cutoff test data results.
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
75-75%8080 Negative
150-50%8080 Negative
225-25%8080 Negative
300Cutoff8037 Negative/43 Positive
375+25%8080 Positive
450+50%8080 Positive
525+75%8080 Positive
600+100%8080 Positive

b. The following is a summary table of the Qualitative Analysis for the 2000ng/mL cutoff test data results.

Table 7 - Qualitative Analysis (for 2000ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
500-75%8080 Negative
1000-50%8080 Negative
1500-25%8080 Negative
2000Cutoff8042 Negative/38 Positive
2500+25%8080 Positive
3000+50%8080 Positive
3500+75%8080 Positive
4000+100%8080 Positive

c. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results.

Table 8 - Semi-Quantitative Analysis (for 300ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
75-75%8080 Negative
150-50%8080 Negative
225-25%8080 Negative
300Cutoff8020 Negative/60 Positive
375+25%8080 Positive

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Table 8 - Semi-Quantitative Analysis (for 300ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
450+50%8080 Positive
525+75%8080 Positive
600+100%8080 Positive

d. The following is a summary table of the Semi-Quantitative Analysis for the 2000ng/mL cutoff test data results.

Table 9 - Semi-Quantitative Analysis (for 2000ng/mL cutoff)
Concentration (ng/mL)% of cutoff# of determinationsResult
0-100%8080 Negative
500-75%8080 Negative
1000-50%8080 Negative
1 200-25%8080 Negative
2000Cutoff8041 Negative/39 Positive
2500+25%8080 Positive
3000+50%8080 Positive
3500+75%8080 Positive
4000+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. The instrument used for this test was a Beckman Coulter AU 400e.
    • a. The qualitative result summary table for the 300ng/mL cutoffs is outlined below:
Table 10 - Structurally Related Compounds (for 300ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
6-Acetylmorphine150POS200.0
Codeine200POS150.0
Dihydrocodeine150POS200.0
Ethylmorphine300POS100.0
Heroin300POS100.0
Hydrocodone400POS75.0
Levorphanol8,000POS3.8
Morphine-3-Glucuronide200POS150.0
Morphine-6-Glucuronide100POS300.0
Hydromorphone700POS42.9
Nalorphine2,000POS15.0
Naloxone60,000POS0.5
Norcodeine25,000POS1.2
Normorphine25,000POS1.2
Oxycodone10,000POS3.0
Oxymorphone20,000POS1.5

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b. The qualitative result summary table for the 2000ng/mL cutoff is outlined below:

Table 11 - Structurally Related Compounds (for 2000ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
6-Acetylmorphine2,000POS100.0
Codeine2,000POS100.0
Dihydrocodeine600POS333.3
Ethylmorphine2,000POS100.0
Heroin4,000POS50.0
Hydrocodone4,000POS50.0
Levorphanol100,000POS2.0
Morphine-3-Glucuronide2,000POS100.0
Morphine-6-Glucuronide600POS333.3
Hydromorphone8,000POS25.0
Nalorphine28,000POS7.1
Naloxone500,000POS0.4
Norcodeine300,000POS0.7
Normorphine300,000POS0.7
Oxycodone100,000POS2.0
Oxymorphone200,000NEG1.0

c. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below:

Table 12 - Structurally Related Compounds (for 300ng/mL cutoff) – Semi-Quantitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
6-Acetylmorphine150POS200.0
Codeine200NEG150.0
Dihydrocodeine150POS200.0
Ethylmorphine300POS100.0
Heroin300POS100.0
Hydrocodone400POS75.0
Levorphanol8,000POS3.8
Morphine-3-Glucuronide200POS150.0
Morphine-6-Glucuronide100POS300.0
Hydromorphone700POS42.9
Nalorphine2,000POS15.0
Naloxone60,000POS0.5
Norcodeine25,000POS1.2
Normorphone25,000POS1.2
Oxycodone10,000POS3.0
Oxymorphone20,000POS1.5

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Table 13 - Structurally Related Compounds (for 2000ng/mL cutoff) – Semi-Quantitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
6-Acetylmorphine2,000POS100.0
Codeine2,000POS100.0
Dihydrocodeine600POS333.3
Ethylmorphine2,000POS100.0
Heroin4,000POS50.0
Hydrocodone4,000POS50.0
Levorphanol100,000POS2.0
Morphine-3-Glucuronide2,000POS100.0
Morphine-6-Glucuronide600POS333.3
Hydromorphone8,000POS25.0
Nalorphine28,000POS7.1
Naloxone500,000POS0.4
Norcodeine300,000POS0.7
Normorphine300,000POS0.7
Oxycodone100,000POS2.0
Oxymorphone200,000NEG1.0
  • d. The semi-quantitative result summary table for the 2000ng/mL cutoff is outlined below:
    1. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferents into drug free urine containing morphine at ±25% of the cutoffs. Boric Acid and Riboflavin caused a false negative response at the concentrations tested. All other potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. 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 300ng/mL cutoff:
Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff
(225ng/mL)+25% Cutoff
(375ng/mL)
ResultInterference?ResultInterference?
4-Bromo-
2,5,Dimethoxyphenethylamine100,000NegativeNoPositiveNo
Acetaminophen500,000NegativeNoPositiveNo
Acetylsalicylic Acid500,000NegativeNoPositiveNo
Alprazolam100,000NegativeNoPositiveNo
Amphetamine500,000NegativeNoPositiveNo
Amitriptyline100,000NegativeNoPositiveNo
Amobarbital100,000NegativeNoPositiveNo
Benzoylecgonine500,000NegativeNoPositiveNo
Benzylpiperazine100,000NegativeNoPositiveNo
Bromazepam100,000NegativeNoPositiveNo
Buprenorphine100,000NegativeNoPositiveNo
Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff)
Concentration-25% Cutoff+25% Cutoff
CompoundTested(225ng/mL)(375ng/mL)
(ng/mL)ResultInterference?ResultInterference?
Buprion100,000NegativeNoPositiveNo
Butabarbital100,000NegativeNoPositiveNo
Caffeine500,000NegativeNoPositiveNo
Carbamazepine100,000NegativeNoPositiveNo
Cocaine100,000NegativeNoPositiveNo
Clomipramine100,000NegativeNoPositiveNo
Clonazepam100,000NegativeNoPositiveNo
Chloropromazine100,000NegativeNoPositiveNo
Cyclobenzaprine100,000NegativeNoPositiveNo
N-Desmethyltapentadol100,000NegativeNoPositiveNo
Desipramine100,000NegativeNoPositiveNo
Dextromethorphan100,000NegativeNoPositiveNo
Diazepam100,000NegativeNoPositiveNo
Diphenhydramine500,000NegativeNoPositiveNo
Doxepin100,000NegativeNoPositiveNo
Ephedrine100,000NegativeNoPositiveNo
EDDP100,000NegativeNoPositiveNo
Ethyl-glucuronide100,000NegativeNoPositiveNo
Fenfluramine100,000NegativeNoPositiveNo
Fluoxetine100,000NegativeNoPositiveNo
Flurazepam100,000NegativeNoPositiveNo
Hexobarbital100,000NegativeNoPositiveNo
Ibuprofen100,000NegativeNoPositiveNo
Imipramine100,000NegativeNoPositiveNo
Ketamine100,000NegativeNoPositiveNo
Lidocaine100,000NegativeNoPositiveNo
LSD100,000NegativeNoPositiveNo
Lorazepam100,000NegativeNoPositiveNo
Maprotiline100,000NegativeNoPositiveNo
MDEA100,000NegativeNoPositiveNo
MDA100,000NegativeNoPositiveNo
MDMA100,000NegativeNoPositiveNo
Meperidine50.000NegativeNoPositiveNo
Methadone500,000NegativeNoPositiveNo
Methaqualone100,000NegativeNoPositiveNo
Methamphetamine500,000NegativeNoPositiveNo
Meprobamate100,000NegativeNoPositiveNo
Naltrexone100,000NegativeNoPositiveNo
Nitrazepam100,000NegativeNoPositiveNo
Norbuprenorphine100,000NegativeNoPositiveNo
Nordiazepam100,000NegativeNoPositiveNo
Nortryptyline100,000NegativeNoPositiveNo
Norpropoxyphene100,000NegativeNoPositiveNo
Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff)
Concentration-25% Cutoff+25% Cutoff
CompoundTested(225ng/mL)(375ng/mL)
(ng/mL)ResultInterference?ResultInterference?
Oxazepam100,000NegativeNoPositiveNo
Pentobarbital100,000NegativeNoPositiveNo
Phenobarbital100,000NegativeNoPositiveNo
Pentazocine100,000NegativeNoPositiveNo
Phencyclidine100,000NegativeNoPositiveNo
Phentermine100,000NegativeNoPositiveNo
Phenylpropanolamine500,000NegativeNoPositiveNo
PMA100,000NegativeNoPositiveNo
(-)Pseudoephedrine100,000NegativeNoPositiveNo
(+)Pseudoephedrine100,000NegativeNoPositiveNo
Phenytoin100,000NegativeNoPositiveNo
Protryptyline100,000NegativeNoPositiveNo
Ranitidine100,000NegativeNoPositiveNo
Ritalinic Acid100,000NegativeNoPositiveNo
Secobarbital100,000NegativeNoPositiveNo
Sufentanil100,000NegativeNoPositiveNo
Temazepam100,000NegativeNoPositiveNo
11-nor-9 carboxy THC100,000NegativeNoPositiveNo
Tramadol100,000NegativeNoPositiveNo
Trimipramine100,000NegativeNoPositiveNo
Venlafaxine100,000NegativeNoPositiveNo

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b. The following is a summary table of the structurally non-similar compounds for the 2000ng/mL cutoff:

Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff
(1500ng/mL)+25% Cutoff
(2500ng/mL)
ResultInterference?ResultInterference?
4-Bromo-
2,5,Dimethoxyphenethylamine100,000NegativeNoPositiveNo
Acetaminophen500,000NegativeNoPositiveNo
Acetylsalicylic Acid500,000NegativeNoPositiveNo
Alprazolam100,000NegativeNoPositiveNo
Amphetamine500,000NegativeNoPositiveNo
Amitriptyline100,000NegativeNoPositiveNo
Amobarbital100,000NegativeNoPositiveNo
Benzoylecgonine500,000NegativeNoPositiveNo
Benzylpiperazine100,000NegativeNoPositiveNo
Bromazepam100,000NegativeNoPositiveNo
Buprenorphine100,000NegativeNoPositiveNo
Buprion100,000NegativeNoPositiveNo
Butabarbital100,000NegativeNoPositiveNo
Caffeine500,000NegativeNoPositiveNo
Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff)
Concentration-25% Cutoff+25% Cutoff
CompoundTested(1500ng/mL)(2500ng/mL)
(ng/mL)ResultInterference?ResultInterference?
Carbamazepine100,000NegativeNoPositiveNo
Cocaine100,000NegativeNoPositiveNo
Clomipramine100,000NegativeNoPositiveNo
Clonazepam100,000NegativeNoPositiveNo
Chloropromazine100,000NegativeNoPositiveNo
Cyclobenzaprine100,000NegativeNoPositiveNo
N-Desmethyltapentadol100,000NegativeNoPositiveNo
Desipramine100,000NegativeNoPositiveNo
Dextromethorphan100,000NegativeNoPositiveNo
Diazepam100,000NegativeNoPositiveNo
Diphenhydramine500,000NegativeNoPositiveNo
Doxepin100,000NegativeNoPositiveNo
Ephedrine100,000NegativeNoPositiveNo
EDDP100,000NegativeNoPositiveNo
Ethyl-glucuronide100,000NegativeNoPositiveNo
Fenfluramine100,000NegativeNoPositiveNo
Fluoxetine100,000NegativeNoPositiveNo
Flurazepam100,000NegativeNoPositiveNo
Hexobarbital100,000NegativeNoPositiveNo
Ibuprofen100,000NegativeNoPositiveNo
Imipramine100,000NegativeNoPositiveNo
Ketamine100,000NegativeNoPositiveNo
Lidocaine100,000NegativeNoPositiveNo
LSD100,000NegativeNoPositiveNo
Lorazepam100,000NegativeNoPositiveNo
Maprotiline100,000NegativeNoPositiveNo
MDEA100,000NegativeNoPositiveNo
MDA100,000NegativeNoPositiveNo
MDMA100,000NegativeNoPositiveNo
Meperidine100,000NegativeNoPositiveNo
Methadone500,000NegativeNoPositiveNo
Methaqualone100,000NegativeNoPositiveNo
Methamphetamine500,000NegativeNoPositiveNo
Meprobamate100,000NegativeNoPositiveNo
Naltrexone100,000NegativeNoPositiveNo
Nitrazepam100,000NegativeNoPositiveNo
Norbuprenorphine100,000NegativeNoPositiveNo
Nordiazepam100,000NegativeNoPositiveNo
Nortryptyline100,000NegativeNoPositiveNo
Norpropoxyphene100,000NegativeNoPositiveNo
Oxazepam100,000NegativeNoPositiveNo
Pentobarbital100,000NegativeNoPositiveNo
Phenobarbital100,000NegativeNoPositiveNo
Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff)
Concentration-25% Cutoff+25% Cutoff
CompoundTested(1500ng/mL)(2500ng/mL)
(ng/mL)ResultInterference?ResultInterference?
Pentazocine100,000NegativeNoPositiveNo
Phencyclidine100,000NegativeNoPositiveNo
Phentermine100,000NegativeNoPositiveNo
Phenylpropanolamine500,000NegativeNoPositiveNo
PMA100,000NegativeNoPositiveNo
(-)Pseudoephedrine100,000NegativeNoPositiveNo
(+)Pseudoephedrine100,000NegativeNoPositiveNo
Phenytoin100,000NegativeNoPositiveNo
Protryptyline100,000NegativeNoPositiveNo
Ranitidine100,000NegativeNoPositiveNo
Ritalinic Acid100,000NegativeNoPositiveNo
Secobarbital100,000NegativeNoPositiveNo
Sufentanil100,000NegativeNoPositiveNo
Temazepam100,000NegativeNoPositiveNo
11-nor-9 carboxy THC100,000NegativeNoPositiveNo
Tramadol100,000NegativeNoPositiveNo
Trimipramine100,000NegativeNoPositiveNo
Venlafaxine100,000NegativeNoPositiveNo

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c. The following is a summary table of the endogenous compounds results for the 300ng/mL cutoff:

Table 16 - Endogenous Compounds (for 300ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff
(225ng/mL)+25% Cutoff
(375ng/mL)
ResultInterference?ResultInterference?
Acetone1.0 g/dLNegativeNoPositiveNo
Ascorbic Acid1.5 g/dLNegativeNoPositiveNo
Bilirubin0.002 g/dLNegativeNoPositiveNo
Creatinine0.5 g/dLNegativeNoPositiveNo
Ethanol1.0 g/dLNegativeNoPositiveNo
Galactose0.01 g/dLNegativeNoPositiveNo
y-Globulin0.5 g/dLNegativeNoPositiveNo
Glucose2.0 g/dLNegativeNoPositiveNo
Hemoglobin0.300 g/dLNegativeNoPositiveNo
Human Serum Albumin0.5 g/dLNegativeNoPositiveNo
Oxalic Acid0.1 g/dLNegativeNoPositiveNo
Riboflavin0.0075 g/dLNegativeNoNegativeYes
Sodium Azide1% w/vNegativeNoPositiveNo
Sodium Chloride6.0 g/dLNegativeNoPositiveNo
Sodium Fluoride1% w/vNegativeNoPositiveNo
Urea6.0 g/dLNegativeNoPositiveNo

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d.Riboflavin interferes with the assay and can cause a falsely low test result. This limitation has been added to the labeling regarding this compound.

  • e. The following is a summary table of the endogenous compounds results for the 2000ng/mL cutoff:
Table 17 - Endogenous Compounds (for 2000ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff
(1500ng/mL)+25% Cutoff
(2500ng/mL)
ResultInterference?ResultInterference?
Acetone1.0 g/dLNegativeNoPositiveNo
Ascorbic Acid1.5 g/dLNegativeNoPositiveNo
Bilirubin0.002 g/dLNegativeNoPositiveNo
Creatinine0.5 g/dLNegativeNoPositiveNo
Ethanol1.0 g/dLNegativeNoPositiveNo
Galactose0.01 g/dLNegativeNoPositiveNo
y-Globulin0.5 g/dLNegativeNoPositiveNo
Glucose2.0 g/dLNegativeNoPositiveNo
Hemoglobin0.300 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/dLNegativeNoPositiveNo
Sodium Fluoride1% w/vNegativeNoPositiveNo
Urea6.0 g/dLNegativeNoPositiveNo

f. The following is a summary table of the Boric Acid for the 300ng/mL cutoff results:

Table 18 - Boric Acid (for 300ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff
(225ng/mL)+25% Cutoff
(375ng/mL)
ResultInterference?ResultInterference?
Boric Acid1% w/vNegativeNoNegativeYes

g. The following is a summary table of the Boric Acid for the 2000ng/mL cutoff results:

Table 19- Boric Acid (for 2000ng/mL cutoff)
CompoundConcentration Tested (ng/mL)-25% Cutoff (1500ng/mL)+25% Cutoff (2500ng/mL)
ResultInterference?ResultInterference?
Boric Acid1% w/vNegativeNoNegativeYes

h.Boric Acid interferes with the assay and can cause a falsely low test result. This limitation has been added to the labeling regarding this compound.

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Table 20 - Effect of pH (for 300ng/mL cutoff)
-25% Cutoff+25% Cutoff
Test ParameterValue(225ng/mL)(375ng/mL)
ResultInterference?ResultInterference?
pH3.0NegativeNoPositiveNo
pH4.0NegativeNoPositiveNo
pH5.0NegativeNoPositiveNo
pH6.0NegativeNoPositiveNo
pH7.0NegativeNoPositiveNo
pH8.0NegativeNoPositiveNo
pH9.0NegativeNoPositiveNo
pH10.0NegativeNoPositiveNo
pH11.0NegativeNoPositiveNo

i. The following is a summary table of the effect of pH results for the 300ng/mL cutoff:

  • j. The following is a summary table of the effect of the pH results for the 2000ng/mL cutoff:
Table 21 - Effect of pH (for 2000ng/mL cutoff)
-25% Cutoff
(1500ng/mL)+25% Cutoff
(2500ng/mL)
Test ParameterValueResultInterference?ResultInterference?
pH3.0NegativeNoPositiveNo
pH4.0NegativeNoPositiveNo
pH5.0NegativeNoPositiveNo
pH6.0NegativeNoPositiveNo
pH7.0NegativeNoPositiveNo
pH8.0NegativeNoPositiveNo
pH9.0NegativeNoPositiveNo
pH10.0NegativeNoPositiveNo
pH11.0NegativeNoPositiveNo

k.The following is a summary table of the effect of specific gravity result for the 300ng/mL cutoff:

Table 22 - Effect of Specific Gravity (for 300ng/mL cutoff)
-25% Cutoff
(225ng/mL)+25% Cutoff
(375ng/mL)
Test ParameterValueResultInterference?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

T

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| Test Parameter | Value | -25% Cutoff
(1500ng/mL) | | +25% Cutoff
(2500ng/mL) | |
|------------------|-------|----------------------------|---------------|----------------------------|---------------|
| | | Result | Interference? | Result | Interference? |
| Specific Gravity | 1.000 | Negative | No | Positive | No |
| Specific Gravity | 1.002 | Negative | No | Positive | No |
| Specific Gravity | 1.005 | Negative | No | Positive | No |
| Specific Gravity | 1.010 | Negative | No | Positive | No |
| Specific Gravity | 1.015 | Negative | No | Positive | No |
| Specific Gravity | 1.020 | Negative | No | Positive | No |
| Specific Gravity | 1.025 | Negative | No | Positive | No |
| Specific Gravity | 1.030 | Negative | No | Positive | No |

    1. The following is a summary table of the effect of specific gravity result for the 2000ng/mI , cutoff-
    1. Linearity/ Recovery A drug free urine pool was spiked with a high concentration of the target analyte as high value specimen. Additional pools were made by serially diluting the high value specimen. The study verified assay linearity in the semi-quantitative mode. The instrument used for this test was a Beckman Coulter AU 400e.
    • a. The following is a summary table of the linearity/recovery for the 300ng/mL cutoff:
Table 24 - Linearity/ Recovery – 300ng/mL
Expected Concentration (ng/mL)Mean Concentration (ng/mL)Recovery (%)
10091.691.6
200203.7101.8
300292.897.6
400410.1102.5
500488.197.6
600651.1108.5
700759.4108.5
800840.6105.1
900906.5100.7
10001024.1102.4
11001069.997.3

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Table 25 - Linearity/ Recovery – 2000ng/mL
Expected Concentration (ng/mL)Mean Concentration (ng/mL)Recovery (%)
600635.0105.8
12001295.2107.9
18001750.997.3
20002079.0104.0
24002231.193.0
30003142.9104.8
36003852.7107.0
42004465.4106.3
48005101.8106.3
54005789.0107.2
60005972.399.5
66006637.7100.6
  • b. The following is a summary table of the linearity/recovery for the 2000ng/mL cutoff.
  • న్. 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 300ng/mL cutoff:
    • Table 26 Method Comparison (for 300ng/mL cutoff) Qualitative
LC/MS Confirmation
(+)(-)
Test
Device(+)401
(-)039

b. The following is a summary table of qualitative assay performance for the 300ng/mL cutoff:

Table 27 - Assay Performance verified by LC/MS – 300ng/mL Cutoff – Qualitative
Opiates ConcentrationAgreement
(%)
Type450 ng/mL
Qualitative/
Positive0153598%
Qualitative/
Negative36300100%

c. The following is a summary table of qualitative discordant results for the 300ng/mL cutoff

Table 28 - Discordant Result Summary – 300ng/mL Cutoff – Qualitative
Qualitative Results
300ng CutoffLC/MS Confirmation
Test DeviceQualitativeTotal Opiate Concentration (ng/mL)
PositiveNegative200

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  • d. The following is a comparison table of qualitative assay performance for the 2000ng/mL cutoff:
    Table 29 - Method Comparison (for 2000ng/mL cutoff) - Qualitative
LC/MS Confirmation
(+)(-)
Test
Device(+)400
Test
Device(-)040

e. The following is a summary table of qualitative assay performance for the 2000ng/mL cutoff:

Table 30 - Assay Performance verified by LC/MS – 2000ng/mL Cutoff - Qualitative
TypeOpiates ConcentrationAgreement (%)
3000ng/mL
Qualitative/
Positive00535100%
Qualitative/
Negative36400100%

f. The following is a comparison table of semi-quantitative assay performance for 300ng/mL:

Table 31 - Method Comparison (for 300ng/mL cutoff) - Semi-Quantitative

LC/MS Confirmation
(+)(-)
Test
Device(+)400
Test
Device(-)040

g. The following is a summary table of semi-quantitative assay performance for the 300ng/mL cutoff:

Table 32 - Assay Performance verified by LC/MS – 300ng/mL Cutoff – Semi-Quantitative
TypeOpiates ConcentrationAgreement
(%)
450 ng/mL
Semi-Quantitative/
Positive00535100%
Semi-Quantitative /
Negative36400100%

h. The following is a comparison table of semi-quantitative assay

performance for the 2000ng/mL cutoff:

Table 33 - Method Comparison (for 2000ng/mL cutoff) - Semi-Quantitative

LC/MS Confirmation
(+)(-)
Test
Device(+)400
(-)040

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  • i. The following is a summary table of semi-quantitative assay performance for the 2000ng/mL cutoff:
Table 34 - Assay Performance verified by LC/MS – 2000ng/mL Cutoff – Semi-Quantitative
TypeOpiates ConcentrationAgreement (%)
3000ng/mL
Semi-Quantitative/
Positive00535100%
Semi-Quantitative /
Negative36400100%

6. Stability -

  • a. A closed accelerated stability study was performed on reagents at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for reagents. The instruments used for this test was a Beckman Coulter AU 400e.
  • b. An open/on-board stability study was performed on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2℃ to 8℃. The stability study supported an initial open vial expiration date of 28 days. The instrument used for this test was a Beckman Coulter AU 400e.
  • c. Real time stability studies are ongoing
    1. Calibrator and Control Analytical Performance Immunalysis Opiates Urine Calibrators 300
    • a. Opiates Calibrator Traceability all components of the calibrators have been traced to a commercially available standard solution.
    • b. Opiates Calibrator Closed Vial Stability An accelerated closed vial stability study was performed at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for Morphine were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
    • c. Opiates Calibrator Open Vial Stability An accelerated open vial stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for Morphine were within specifications for Day 0, 19, 26, 33, 41, and 60. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
    • d. Opiates Calibrator Value Assignment Calibrators are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrators are adjusted and re-tested. Values

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are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.

    1. Calibrator and Control Analytical Performance Immunalysis Multi-Drug Controls
    • a. Multi-Drug Control Traceability all components of the controls have been traced to a commercially available standard solution.
    • b. Multi-Drug Control Closed Vial Stability An accelerated closed vial stability study was performed at 25℃ to establish the initial expiration dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All control levels (Low Control 1 and 2 and High Control 1 and 2) for Benzoylegonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
    • c. Multi-Drug Control Open Vial Stability An open vial stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer, All control levels (Low Control 1 and 2 and High Control 1 and 2) for Benzovlegonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam were within specifications for Day 0, 19, 26, 33, 41, and 60. This stability study was performed to establish initial expiration dating.
    • d. Multi-Drug Control Value Assignment Controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the controls are adjusted and re-tested. Values are assigned to the controls once the mass spectrometry results are within the acceptable ranges.
    1. Calibrator Analytical Performance Immunalysis Opiates Urine Calibrators 2000
    • a. Opiates Urine Calibrators Traceability all components of the calibrators have been traced to a commercially available standard solution.
      • b. Opiates Urine Calibrators Closed Vial Stability An accelerated stability study was performed at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for Morphine were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
      • c. Opiates Urine Calibrators Open Vial Stability A stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for Morphine were within specifications for Day 0. 19. 26. 33. 41.

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and 60. This stability study was performed to establish initial expiration dating.

  • d. Opiates Urine Calibrators Value Assignment Calibrators are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrators is adjusted and retested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
  • I. Conclusion

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