(58 days)
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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 Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Amphetamine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes amphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The amphetamine calibrator and controls consist of dual cutoff calibrators at 500ng/mL and 1000ng/mL, a control set containing a LOW control at 375ng/mL and a HIGH control at 625ng/mL for the 500ng/mL cutoff and a LOW control at 750ng/mL and HIGH control at 1250ng/mL for the 1000ng/mL cutoff, and a calibrator set containing a negative calibrator, a Level 1 calibrator at 500ng/mL, a Level 2 calibrator at 1000ng/mL, a Level 3 calibrator at 1500ng/mL, and a Level 4 calibrator at 2000ng/mL.
The Immunalysis Amphetamine Urine Enzyme Immunoassay, along with its calibrators and controls, is intended for the qualitative and semi-quantitative analysis of Amphetamine in human urine using automated clinical chemistry analyzers. The assay offers dual cutoffs of 500 ng/mL and 1000 ng/mL. The semi-quantitative mode is used to determine appropriate specimen dilution for confirmation by methods like GC-MS or LC/MS. The device is for prescription use only and provides a preliminary analytical result, requiring a more specific alternate chemical method for confirmation.
Here's an overview of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a structured table. However, the performance studies implicitly define the criteria for acceptable performance in each category. The reported device performance is presented in summarized tables for each study.
| Study Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision/Cutoff Characterization | Qualitative results should correctly identify samples as negative or positive relative to the cutoff, with minimal indeterminate results at the cutoff. | 500 ng/mL cutoff: |
| - At 0, 125, 250, 375 ng/mL (negative range), all 80 determinations were Negative. | - At 0, 125, 250, 375 ng/mL: 80 Negative | |
| - At 625, 750, 875, 1000 ng/mL (positive range), all 80 determinations should be Positive. | - At 500 ng/mL (Cutoff): 48 Negative / 32 Positive | |
| - At the cutoff (500 ng/mL or 1000 ng/mL), a mix of negative and positive results is expected reflecting the boundary. | - At 625, 750, 875, 1000 ng/mL: 80 Positive | |
| 1000 ng/mL cutoff: | ||
| - At 0, 250, 500, 750 ng/mL: 80 Negative | ||
| - At 1000 ng/mL (Cutoff): 47 Negative / 33 Positive | ||
| - At 1250, 1500, 1750, 2000 ng/mL: 80 Positive | ||
| Specificity/Cross-Reactivity | Structurally similar compounds should exhibit expected levels of cross-reactivity, and structurally non-similar compounds should show no interference. | Demonstrated specified cross-reactivity percentages for similar compounds and "No Interference" for non-similar compounds, endogenous compounds, Boric Acid, and various pH/specific gravity levels. (See tables 5-18 in the document for detailed performance). |
| Interference | Exogenous (non-similar compounds, Boric Acid) and endogenous compounds, as well as variations in pH and specific gravity, should not lead to false positive or false negative results around the cutoff values. | All tested compounds and conditions: No Interference for both -25% and +25% of cutoff concentrations when tested against potentially interfering substances, various pH levels (3.0-11.0), and specific gravity levels (1.000-1.030). (See tables 9-18 in the document for detailed performance). |
| Linearity/Recovery | The assay should demonstrate linearity and acceptable recovery across a range of amphetamine concentrations in the semi-quantitative mode. | Mean Recovery across a range of 200 ng/mL to 2200 ng/mL varied between 76.2% and 107.1% (Table 19). |
| Method Comparison | High agreement (e.g., 100% or near 100%) between the test device results and confirmed LC/MS results. | 500 ng/mL cutoff (Qualitative & Semi-quantitative): 100% agreement between test device and LC/MS (40 positive, 40 negative). |
| 1000 ng/mL cutoff (Qualitative & Semi-quantitative): 98% agreement. One discordant sample (Sample ID 395246ZA) was negative by the test device but confirmed at 1173 ng/mL by LC/MS (above the 1000 ng/mL cutoff, representing a false negative by the device at this specific instance for semi-quantitative). | ||
| Stability | Assays, calibrators, and controls should remain stable for a specified duration under defined storage conditions. | 1-year expiration date for reagents (closed accelerated stability to 25℃). 12-month expiration for calibrators and controls (closed accelerated stability to 25℃). 28-day open vial expiration for reagents (on-board stability at 2℃ to 8℃). 6-month open vial expiration for calibrators and controls (accelerated stability at 25℃). Real-time stability studies are ongoing. |
2. Sample Sizes used for the Test Set and Data Provenance:
- Precision/Cutoff Characterization Study: 80 determinations for each concentration level tested (20 days, 2 runs per day, in duplicate).
- Specificity and Cross-Reactivity: Not explicitly stated as a "sample size" of unique patient samples, but each specified compound was spiked into "drug free urine" at various concentrations.
- Interference: Similarly, not a "sample size" of unique patient samples, but various potential interferents (structurally non-similar compounds, endogenous compounds, Boric Acid) were spiked into "drug free urine" containing the target analyte at ±25% of the cutoff. pH and Specific Gravity effects were also evaluated under these conditions.
- Linearity/Recovery: Not explicitly stated as a "sample size" of unique patient samples, but serial dilutions were made from a "drug free urine pool" spiked with a high concentration of the target analyte.
- Method Comparison: 80 clinical urine samples (40 positive, 40 negative) for the 500 ng/mL cutoff and 81 clinical urine samples (41 positive, 40 negative) for the 1000 ng/mL cutoff.
- Data Provenance: The Method Comparison study used "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." The country of origin is not specified but is implicitly the USA, given the FDA submission. The data is retrospective, as it used discarded clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Ground truth for Method Comparison: The ground truth was established by Mass Spectrometry, specifically using an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry (LC/MS). This is an objective analytical method and does not involve human expert consensus for interpretation in the same way, for example, a radiologist would interpret an image. Therefore, the concept of "number of experts" or "qualifications of experts" as typically applied to imaging studies does not directly apply here.
4. Adjudication Method for the Test Set:
- Not applicable in the conventional sense. The "ground truth" for the method comparison study was established by LC/MS, which is a definitive chemical analysis method, not requiring a human adjudication process to resolve disagreements between readers/interpreters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or other diagnostic tests, sometimes with and without AI assistance, to assess the AI's impact on human performance. The current document describes an in-vitro diagnostic device for chemical analysis of urine, which does not involve human readers interpreting complex cases in the same manner as an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance presented for the Immunalysis Amphetamine Urine Enzyme Immunoassay is the standalone performance of the algorithm/device. The device automatically analyzes urine samples and provides qualitative and semi-quantitative results. Human involvement is in operating the automated clinical chemistry analyzer and interpreting the final quantitative values against cutoffs, but the core "performance" data (e.g., precision, cross-reactivity, method comparison against LC/MS) reflects the device's inherent analytical capabilities without a human interpretation step influencing the reported results in the study itself.
7. The Type of Ground Truth Used:
- For the analytical performance studies (Precision, Specificity, Interference, Linearity), the ground truth was based on known concentrations of spiked analytes in drug-free urine.
- For the Method Comparison study, the ground truth was established by a confirmatory method: Liquid Chromatography/Mass Spectrometry (LC/MS). This is a highly sensitive and specific analytical technique considered the gold standard for confirming drug presence and concentration in urine.
8. The Sample Size for the Training Set:
- The document does not report on a training set in the context of an "algorithm" that needs to be "trained." This is an in-vitro diagnostic immunoassay kit, which relies on chemical reactions and optical readings rather than machine learning algorithms trained on large datasets. Therefore, the concept of a "training set" for an AI model is not applicable here. The device is fundamentally a chemical measurement system.
9. How the Ground Truth for the Training Set Was Established:
- As stated above, this device is a chemical immunoassay, not an AI/ML algorithm requiring a training set. Therefore, this question is not applicable.
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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 DRIVE POMONA CA 91767
February 6, 2015
Re: K143500
Trade/Device Name: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DLJ, LAS Dated: December 9, 2014 Received: December 10, 2014
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
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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 -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
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Indications for Use
510(k) Number (if known) K143500
Device Name
Immunalysis Amphetamine Urine Enzyne Immunalysis Amphetamine Urine Calibrators, Immunalysis Amphetamine Urine Control Set
Indications for Use (Describe)
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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 Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine 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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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 |
| 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: | January 27, 2015 |
| B. | Device Information | |
| 1. | Trade Name: | Immunalysis Amphetamine Urine Enzyme ImmunoassayImmunalysis Amphetamine Urine ControlsImmunalysis Amphetamine Urine Calibrators |
| 2. | Common Name: | Immunalysis Amphetamine Urine Enzyme ImmunoassayImmunalysis Amphetamine Urine ControlsImmunalysis Amphetamine Urine Calibrators |
| 3. | Device Classification: | II |
| 4. | Regulation Number: | CFR 862.3100 Enzyme Immunoassay, AmphetamineCFR 862.3200 Calibrators, Drug SpecificCFR 862.3280 Drug Specific Control Materials |
| 5. | Panel: | Toxicology(91) |
| 6. | Product Code: | DKZDLJLAS |
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IMMUNALYSIS
C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
| 1. Predicate Device: | VITROS® Chemistry Products AMPH ReagentVITROS® Chemistry Products Calibrator Kit 26VITROS® Chemistry Products FS Calibrator 1VITROS® Chemistry Products DAT PerformanceVerifiers I, II, III, IV and V |
|---|---|
| 2. Predicate Company: | Ortho-Clinical Diagnostics, Inc |
| 3. Predicate K Number: | K062077 |
D. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Amphetamine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes amphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The amphetamine calibrator and controls consist of dual cutoff calibrators at 500ng/mL and 1000ng/mL, a control set containing a LOW control at 375ng/mL and a HIGH control at 625ng/mL for the 500ng/mL cutoff and a LOW control at 750ng/mL and HIGH control at 1250ng/mL for the 1000ng/mL cutoff, and a calibrator set containing a negative calibrator, a Level 1 calibrator at 500ng/mL, a Level 2 calibrator at 1000ng/mL, a Level 3 calibrator at 1500ng/mL, and a Level 4 calibrator at 2000ng/mL.
- E. Intended Use
The Immunalysis Amphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with dual cutoffs of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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.
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Immunalysis Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Controls are used as control materials in Imunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators are used as calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers
| Item | Amphetamine Assay K062077 | Immunalysis Amphetamine Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi-quantitative determination of thepresence of amphetamine in humanurine at a cutoff of 500ng/mL and1000ng/mL | For the qualitative and semi-quantitativedetermination of the presence ofamphetamine in human urine at a cutoff of500ng/mL and 1000ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Amphetamine | Amphetamine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 500ng/mL and 1000ng/mL ofAmphetamine | 500ng/mL and 1000ng/mL ofAmphetamine |
| Test System | Homogeneous Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | Liquid Ready-to-Use Two ReagentAssay (R1 and R2) | Antibody/Substrate Reagents and EnzymeLabeled Conjugate |
| Mass SpectroscopyConfirmation | Required for preliminary positiveanalytical results | Required for preliminary positiveanalytical results |
| Antibody | Mouse Monoclonal antibodies toAmphetamine and Methamphetamine | Monoclonal antibody to Amphetamine |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Six (6) Levels | Two (2) Levels and Five (5) Levels |
| Control Levels | Five (5) Levels | Four (4) Levels |
-
F. Comparison of the new device with the predicate device
G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Amphetamine Urine Enzyme Immunoassay to the predicate -
Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per 1. 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 that 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.
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| Table 1 - Qualitative Analysis (for 500ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 125 | -75% | 80 | 80 Negative |
| 250 | -50% | 80 | 80 Negative |
| 375 | -25% | 80 | 80 Negative |
| 500 | Cutoff | 80 | 48 Negative / 32 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |
- a. The following is a summary table of the Qualitative Analysis for the 500ng/mL cutoff test data results.
- b. The following is a summary table of the Qualitative Analysis for the 1000ng/mL cutoff test data results
| Table 2 - Qualitative Analysis (for 1000 ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 250 | -75% | 80 | 80 Negative |
| 500 | -50% | 80 | 80 Negative |
| 750 | -25% | 80 | 80 Negative |
| 1000 | Cutoff | 80 | 47 Negative / 33 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
c. The following is a summary table of the Semi-Quantitative Analysis for the 500ng/mL cutoff test data results.
| Table 3 - Semi-Quantitative Analysis (for 500ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 125 | -75% | 80 | 80 Negative |
| 250 | -50% | 80 | 80 Negative |
| 375 | -25% | 80 | 80 Negative |
| 500 | Cutoff | 80 | 31 Negative / 49 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |
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| Table 4 - Semi-Quantitative Analysis (for 1000ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 250 | -75% | 80 | 80 Negative |
| 500 | -50% | 80 | 80 Negative |
| 750 | -25% | 80 | 80 Negative |
| 1000 | Cutoff | 80 | 36 Negative / 44 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
- d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results
-
- 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 500ng/mL cutoff is outlined below:
| Table 5 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Amphetamine | 500 | POS | 100.0 |
| (-) Amphetamine | 100,000 | POS | 0.5 |
| (±) Amphetamine | 1,300 | POS | 38.5 |
| MDA | 1,500 | POS | 33.3 |
| PMA | 2,000 | POS | 25.0 |
| Tyramine | 100,000 | POS | 0.5 |
| MDMA | 500,000 | POS | 0.1 |
| MDEA | 100,000 | POS | 0.5 |
| Phenylpropanolamine | 500,000 | POS | 0.1 |
| Phentermine | 1,000,000 | POS | 0.05 |
| (+) Methamphetamine | 1,000,000 | POS | 0.05 |
| (-) Methamphetamine | 1,000,000 | NEG | N.D. |
| (+) Ephedrine | 1,000,000 | NEG | N.D. |
| (-) Ephedrine | 1,000,000 | NEG | N.D. |
| (+) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| (-) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| Phenylephrine | 1,000,000 | NEG | N.D. |
| Diphenylhydramine | 1,000,000 | NEG | N.D. |
| Fenfluramine | 1,000,000 | NEG | N.D. |
N.D. =< 0.05%
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- b. The qualitative result summary table for the 1000ng/mL cutoff is outlined below:
| Table 6 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Amphetamine | 1000 | POS | 100.0 |
| (-) Amphetamine | 200,000 | POS | 0.5 |
| (+) Amphetamine | 2,500 | POS | 40.0 |
| MDA | 2,000 | POS | 50.0 |
| PMA | 4,000 | POS | 25.0 |
| Tyramine | 400,000 | POS | 0.3 |
| MDMA | 1,000,000 | NEG | N.D. |
| MDEA | 400,000 | POS | 0.3 |
| Phenylpropanolamine | 1,000,000 | NEG | N.D. |
| Phentermine | 1,000,000 | NEG | N.D. |
| (+) Methamphetamine | 1,000,000 | NEG | N.D. |
| (-) Methamphetamine | 1,000,000 | NEG | N.D. |
| (+) Ephedrine | 1,000,000 | NEG | N.D. |
| (-) Ephedrine | 1,000,000 | NEG | N.D. |
| (+) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| (-) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| Phenylephrine | 1,000,000 | NEG | N.D. |
| Diphenylhydramine | 1,000,000 | NEG | N.D. |
| Fenfluramine | 1,000,000 | NEG | N.D. |
N.D. =< 0.05%
- c. The semi-quantitative result summary table for the 500ng/mL cutoff is outlined below:
| Table 7 - Structurally Related Compounds (for 500ng/mL cutoff) – Semi-Quantitative | ||
|---|---|---|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| (+) Amphetamine | 500 | 100.0 |
| (-) Amphetamine | 100,000 | 0.5 |
| (±) Amphetamine | 1,300 | 38.5 |
| MDA | 1,500 | 33.3 |
| PMA | 2,000 | 25.0 |
| Tyramine | 100,000 | 0.5 |
| MDMA | 500,000 | 0.1 |
| MDEA | 100,000 | 0.5 |
| Phenylpropanolamine | 500,000 | 0.1 |
| Phentermine | 1,000,000 | 0.05 |
| (+) Methamphetamine | 1,000,000 | 0.05 |
| (-) Methamphetamine | 1,000,000 | N.D. |
| (+) Ephedrine | 1,000,000 | N.D. |
| (-) Ephedrine | 1,000,000 | N.D. |
| (+) Pseudoephedrine | 1,000,000 | N.D. |
| (-) Pseudoephedrine | 1,000,000 | N.D. |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects or details in the image. The font is sans-serif and the letters are bolded.
| Table 7 - Structurally Related Compounds (for 500ng/mL cutoff) – Semi-Quantitative | ||
|---|---|---|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| Phenylephrine | 1,000,000 | N.D. |
| Diphenylhydramine | 1,000,000 | N.D. |
| Fenfluramine | 1,000,000 | N.D. |
N.D. = < 0.05%
- d. The semi-quantitative result summary table for the 1000ng/mL cutoff is outlined below:
| Table 8 - Structurally Related Compounds (for 1000ng/mL cutoff) - Semi-Quantitative | ||
|---|---|---|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| (+) Amphetamine | 1000 | 100.0 |
| (-) Amphetamine | 200,000 | 0.5 |
| (±) Amphetamine | 2,500 | 40.0 |
| MDA | 2,000 | 50.0 |
| PMA | 4,000 | 25.0 |
| Tyramine | 400,000 | 0.3 |
| MDMA | 1,000,000 | N.D. |
| MDEA | 400,000 | 0.3 |
| Phenylpropanolamine | 1,000,000 | N.D. |
| Phentermine | 1,000,000 | N.D. |
| (+) Methamphetamine | 1,000,000 | N.D. |
| (-) Methamphetamine | 1,000,000 | N.D. |
| (+) Ephedrine | 1,000,000 | N.D. |
| (-) Ephedrine | 1,000,000 | N.D. |
| (+) Pseudoephedrine | 1,000,000 | N.D. |
| (-) Pseudoephedrine | 1,000,000 | N.D. |
| Phenylephrine | 1,000,000 | N.D. |
| Diphenylhydramine | 1,000,000 | N.D. |
| Fenfluramine | 1,000,000 | N.D. |
N.D. =< 0.05%
-
- 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. All 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 500ng/mL cutoff :
| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
| 4-Bromo- 2 ,5 ,Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | |||||
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicyclic Acid | 500,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No |
| Bromazepam | 100,000 | Negative | No | Positive | No |
| Buprenorphine | 100,000 | Negative | No | Positive | No |
| Bupropion | 100,000 | Negative | No | Positive | No |
| Butabarbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Chlorpromazine | 100,000 | Negative | No | Positive | No |
| Chrlordiazepoxide | 100,000 | Negative | No | Positive | No |
| cis-Tramadol | 100,000 | Negative | No | Positive | No |
| Clobazam | 100,000 | Negative | No | Positive | No |
| Clomipramine | 100,000 | Negative | No | Positive | No |
| Clonazepam | 100,000 | Negative | No | Positive | No |
| Cocaine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| N-Demethyltapentadol | 100,000 | Negative | No | Positive | No |
| Delta-9-THC | 100,000 | Negative | No | Positive | No |
| Desipramine | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| EDDP | 100,000 | Negative | No | Positive | No |
| Ethyl ẞ-D-glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Flunitrazepam | 100,000 | Negative | No | Positive | No |
| Fluoxetine | 100,000 | Negative | No | Positive | No |
| Flurazepam | 100,000 | Negative | No | Positive | No |
| Heroin | 100,000 | Negative | No | Positive | No |
| Hexobarbital | 100,000 | Negative | No | Positive | No |
| Hydrocodone | 100,000 | Negative | No | Positive | No |
| Hydromorphone | 100,000 | Negative | No | Positive | No |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 100,000 | Negative | No | Positive | No |
| Imipramine | 100,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Levorphanol Tartrate | 100,000 | Negative | No | Positive | No |
| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | |||||
| Concentration | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | |||
| Compound | Tested (ng/mL) | Result | Interference? | Result | Interference? |
| Lidocaine | 100,000 | Negative | No | Positive | No |
| Lorazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| Methadone | 500,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methylphenidate | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-6 -glucuronide | 100,000 | Negative | No | Positive | No |
| Nalorphine | 100,000 | Negative | No | Positive | No |
| Naloxone | 100,000 | Negative | No | Positive | No |
| Naltrexone | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 100,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norpropoxyphene | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Oxazepam | 100,000 | Negative | No | Positive | No |
| Oxycodone | 100,000 | Negative | No | Positive | No |
| Oxymorphone | 100,000 | Negative | No | Positive | No |
| PCP | 100,000 | Negative | No | Positive | No |
| Pentazocine | 100,000 | Negative | No | Positive | No |
| Pentobarbital | 100,000 | Negative | No | Positive | No |
| Phenobarbital | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbial | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No |
| Thioridazine | 100,000 | Negative | No | Positive | No |
| Triazolam | 100,000 | Negative | No | Positive | No |
| Trifluoromethylphenyl- | 100,000 | Negative | No | Positive | No |
| piperazine | |||||
| Trimipramine | 100,000 | Negative | No | Positive | No |
| Venlafaxine | 100,000 | Negative | No | Positive | No |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects in the image.
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Image /page/11/Picture/0 description: The image contains the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The background is a solid red color, and the letters are a bright white color. The image is simple and easy to read.
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Image /page/12/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects in the image.
| Table 10 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| 4-Bromo- 2 ,5 ,Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicyclic Acid | 500,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No |
| Bromazepam | 100,000 | Negative | No | Positive | No |
| Buprenorphine | 100,000 | Negative | No | Positive | No |
| Bupropion | 100,000 | Negative | No | Positive | No |
| Butabarbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Chlorpromazine | 100,000 | Negative | No | Positive | No |
| Chlordiazepoxide | 100,000 | Negative | No | Positive | No |
| cis-Tramadol | 100,000 | Negative | No | Positive | No |
| Clobazam | 100,000 | Negative | No | Positive | No |
| Clomipramine | 100,000 | Negative | No | Positive | No |
| Clonazepam | 100,000 | Negative | No | Positive | No |
| Cocaine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| N-Demethyltapentadol | 100,000 | Negative | No | Positive | No |
| Delta-9-THC | 100,000 | Negative | No | Positive | No |
| Desipramine | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| EDDP | 100,000 | Negative | No | Positive | No |
| Ethyl ẞ-D-glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Flunitrazepam | 100,000 | Negative | No | Positive | No |
| Fluoxetine | 100,000 | Negative | No | Positive | No |
| Flurazepam | 100,000 | Negative | No | Positive | No |
| Heroin | 100,000 | Negative | No | Positive | No |
| Hexobarbital | 100,000 | Negative | No | Positive | No |
| Table 10 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Hydrocodone | 100,000 | Negative | No | Positive | No |
| Hydromorphone | 100,000 | Negative | No | Positive | No |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 100,000 | Negative | No | Positive | No |
| Imipramine | 100,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Levorphanol Tartrate | 100,000 | Negative | No | Positive | No |
| Lidocaine | 100,000 | Negative | No | Positive | No |
| Lorazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| Methadone | 500,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methylphenidate | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-6 -glucuronide | 100,000 | Negative | No | Positive | No |
| Nalorphine | 100,000 | Negative | No | Positive | No |
| Naloxone | 100,000 | Negative | No | Positive | No |
| Naltrexone | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 100,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norpropoxyphene | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Oxazepam | 100,000 | Negative | No | Positive | No |
| Oxycodone | 100,000 | Negative | No | Positive | No |
| Oxymorphone | 100,000 | Negative | No | Positive | No |
| PCP | 100,000 | Negative | No | Positive | No |
| Pentazocine | 100,000 | Negative | No | Positive | No |
| Pentobarbital | 100,000 | Negative | No | Positive | No |
| Phenobarbital | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbial | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| Table 10 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (750ng/mL)Result | -25% Cutoff (750ng/mL)Interference? | +25% Cutoff (1250ng/mL)Result | +25% Cutoff (1250ng/mL)Interference? |
| 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No |
| Thioridazine | 100,000 | Negative | No | Positive | No |
| Triazolam | 100,000 | Negative | No | Positive | No |
| Trifluoromethylphenyl-piperazine | 100,000 | Negative | No | Positive | No |
| Trimipramine | 100,000 | Negative | No | Positive | No |
| Venlafaxine | 100,000 | Negative | No | Positive | No |
b. The following is a summary table of the structurally non-similar compounds for the 1,000ng/mL cutoff:
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image contains the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The background is a solid red color, and the letters are a bright white color. The image is simple and easy to read.
{14}------------------------------------------------
IMMUNALYSIS
c. The following is a summary table of the endogenous compounds results for the 500ng/mL cutoff:
| Table 11 - Endogenous Compounds (for 500ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
| Acetone | 1.0 g/dL | Negative | No | Positive | No |
| Ascorbic Acid | 1.5 g/dL | Negative | No | Positive | No |
| Bilirubin | 0.002 g/dL | Negative | No | Positive | No |
| Creatinine | 0.5 g/dL | Negative | No | Positive | No |
| Ethanol | 1.0 g/dL | Negative | No | Positive | No |
| Galactose | 0.01 g/dL | Negative | No | Positive | No |
| y-Globulin | 0.5 g/dL | Negative | No | Positive | No |
| Glucose | 2.0 g/dL | Negative | No | Positive | No |
| Hemoglobin | 0.150 g/dL | Negative | No | Positive | No |
| Human Serum Albumin | 0.5 g/dL | Negative | No | Positive | No |
| Oxalic Acid | 0.1 g/dL | Negative | No | Positive | No |
| Riboflavin | 0.0075 g/dL | Negative | No | Positive | No |
| Sodium Azide | 1% w/v | Negative | No | Positive | No |
| Sodium Chloride | 6.0 g/dL | Negative | No | Positive | No |
| Sodium Flouride | 1% w/v | Negative | No | Positive | No |
| Urea | 6.0 g/dL | Negative | No | Positive | No |
d. The following is a summary table of the endogenous compounds results for the 1,000ng/mL cutoff:
| Table 12 - Endogenous Compounds (for 1000ng/mL cutoff) | ||||||
|---|---|---|---|---|---|---|
| Concentration | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||||
| Compound | Tested (ng/mL) | Result | Interference? | Result | Interference? | |
| Acetone | 1.0 g/dL | Negative | No | Positive | No | |
| Ascorbic Acid | 1.5 g/dL | Negative | No | Positive | No | |
| Bilirubin | 0.002 g/dL | Negative | No | Positive | No | |
| Creatinine | 0.5 g/dL | Negative | No | Positive | No | |
| Ethanol | 1.0 g/dL | Negative | No | Positive | No | |
| Galactose | 0.01 g/dL | Negative | No | Positive | No | |
| y-Globulin | 0.5 g/dL | Negative | No | Positive | No | |
| Glucose | 2.0 g/dL | Negative | No | Positive | No | |
| Hemoglobin | 0.150 g/dL | Negative | No | Positive | No |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color, and the white letters stand out clearly against it. The image is simple and easy to read.
| Table 12 - Endogenous Compounds (for 1000ng/mL cutoff) | ||||
|---|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (750ng/mL) Result | +25% Cutoff (1250ng/mL) Result | Interference? |
| Human Serum Albumin | 0.5 g/dL | Negative | Positive | No |
| Oxalic Acid | 0.1 g/dL | Negative | Positive | No |
| Riboflavin | 0.0075 g/dL | Negative | Positive | No |
| Sodium Azide | 1% w/v | Negative | Positive | No |
| Sodium Chloride | 6.0 g/dL | Negative | Positive | No |
| Sodium Flouride | 1% w/v | Negative | Positive | No |
| Urea | 6.0 g/dL | Negative | Positive | No |
e. The following is a summary table of Boric Acid for the 500ng/mL cutoff results:
| Table 13 – Boric Acid (for 500ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Boric Acid | 1% w/v | Negative | No | Positive | No |
f. The following is a summary table of the Boric Acid for the 1,000ng/mL cutoff results:
| Compound | ConcentrationTested (ng/mL) | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||
|---|---|---|---|---|---|
| Result | Interference? | Result | Interference? | ||
| Boric Acid | 1% w/v | Negative | No | Positive | No |
g. The following is a summary table of the effect of pH results for the 500ng/mL cutoff:
| Table 15 - Effect of pH (for 500ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| pH | 3.0 | Negative | No | Positive | No |
| pH | 4.0 | Negative | No | Positive | No |
| pH | 5.0 | Negative | No | Positive | No |
| pH | 6.0 | Negative | No | Positive | No |
| pH | 7.0 | Negative | No | Positive | No |
| pH | 8.0 | Negative | No | Positive | No |
| pH | 9.0 | Negative | No | Positive | No |
| pH | 10.0 | Negative | No | Positive | No |
| pH | 11.0 | Negative | No | Positive | No |
h. The following is a summary table of the effect of pH results for the 1,000ng/mL cutoff:
| Table 16 - Effect of pH (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| pH | 3.0 | Negative | No | Positive | No |
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving the image a sense of depth. The red background is a solid color, providing a strong contrast to the white letters.
| Table 16 - Effect of pH (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| pH | 4.0 | Negative | No | Positive | No |
| pH | 5.0 | Negative | No | Positive | No |
| pH | 6.0 | Negative | No | Positive | No |
| pH | 7.0 | Negative | No | Positive | No |
| pH | 8.0 | Negative | No | Positive | No |
| pH | 9.0 | Negative | No | Positive | No |
| pH | 10.0 | Negative | No | Positive | No |
| pH | 11.0 | Negative | No | Positive | No |
- i. The following is a summary table of the effect of specific gravity results for 500ng/mL cutoff:
| Table 17 - Effect of Specific Gravity (for 500ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/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 |
- j. The following is a summery table of the effect of specific gravity results for 1,000ng/mL cutoff:
| Table 18 - Effect of Specific Gravity (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff (750ng/mL) | +25% Cutoff (1250ng/mL) | ||||
| Test Parameter | Value | 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 |
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- Linearity/ Recovery A drug free urine pool was spiked with high concentration of the target analyte as a 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.
| Table 19 - Linearity/ Recovery | ||
|---|---|---|
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
| 200 | 152.3 | 76.2 |
| 400 | 367.5 | 91.9 |
| 500 | 504.4 | 100.9 |
| 600 | 614.4 | 102.4 |
| 800 | 856.5 | 107.1 |
| 1000 | 1026.9 | 102.7 |
| 1200 | 1171.4 | 97.6 |
| 1400 | 1357.1 | 96.9 |
| 1600 | 1461.1 | 91.3 |
| 1800 | 1714.0 | 95.2 |
| 2000 | 2046.5 | 102.3 |
| 2200 | 2256.4 | 102.6 |
a. The following is a summary table of the linearity/recovery:
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- 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 500ng/mL cutoff:
| Table 20 - Method Comparison (for 500ng/mL cutoff) - Qualitative | ||
|---|---|---|
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | (+) | 40 | 0 |
| Device | (-) | 0 | 40 |
b.The following is a summary table of qualitative assay performance for the 500ng/mL cutoff:
| Type | Amphetamine Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| < 250ng/mL | 250 ~ 499 ng/mL | 500 ~ 750 ng/mL | > 750 ng/mL | ||
| Qualitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ Negative | 36 | 4 | 0 | 0 | 100 |
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- c. The following is a comparison table of qualitative assay performance for the 1,000ng/mL cutoff:
Table 22 - Method Comparison (for 1000ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 1 | 40 |
d. The following is a summary table of qualitative assay performance for the 1,000ng/mL
| Table 23 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Amphetamine Concentration | Agreement(%) | |||
| < 500ng/mL | 500 ~ 999 ng/mL | 1000 ~ 1500 ng/mL | > 1500 ng/mL | ||
| Qualitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ Negative | 34 | 6 | 1 | 0 | 98 |
e. The following is a summary table of qualitative discordant results for the 1000ng/mL cutoff
| Table 24 - Discordant Result Summary – 1000ng/mL Cutoff – Qualitative | |||
|---|---|---|---|
| Sample ID | In-House ID | Qualitative Results 1000ng/mL CutoffTest Device | LC/MS ConfirmationAmphetamine |
| 395246ZA | 16558 | Negative | 1173ng/mL |
f. The following is a comparison table of semi-quantitative assay performance for the 500ng/mL cutoff:
Table 25 - Method Comparison (for 500ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 0 | 40 |
g. The following is a summary table of semi-quantitative assay performance for the 500ng/mL cutoff:
| Table 26 - Assay Performance verified by LC/MS – 500ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Amphetamine Concentration | Agreement(%) | |||
| < 250ng/mL | 250 ~ 499 ng/mL | 500 ~ 750 ng/mL | > 750 ng/mL | ||
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative / Negative | 36 | 4 | 0 | 0 | 100 |
h.The following is a comparison table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
Table 27 - Method Comparison (for 1000ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 1 | 40 |
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i. The following is a summary table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
| Type | Amphetamine Concentration | Agreement(%) | |||
|---|---|---|---|---|---|
| <500ng/mL | 500 ~ 999 ng/mL | 1000 ~ 1500 ng/mL | > 1500 ng/mL | ||
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative / Negative | 34 | 6 | 1 | 0 | 98 |
j. The following is a summary table of semi-quantitative discordant results for the 1000ng/mL cutoff
| Table 29 - Discordant Result Summary – 1000ng/mL Cutoff – Semi-Quantitative | ||||
|---|---|---|---|---|
| Sample ID | In-House ID | Semi-Quantitative Results 1000ng/mL Cutoff | LC/MS Confirmation | |
| Value | Result | Amphetamine | ||
| 395246ZA | 16558 | 620.6 | Negative | 1173ng/mL |
- Stability -
- a. A closed accelerated stability study was performed on reagents, calibrators and controls at 25℃ 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 calibrators and controls. The instrument used for this test was a Beckman Coulter AU 400e. Real time stability studies are ongoing.
- 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 Beckman Coulter AU 400e.
-
- Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution
-
- Calibrator and Control Stability - An open accelerated stability study was performed at 25°C to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 6 months. The instrument used for this test was a Beckman Coulter AU 400e. All calibrator levels (500, 1,000, 1,500, and 2,000ng/mL) and control levels (375,625, 750, 1,250ng/mL) were within specifications for Day 0, 8, 16, 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 calibrators and controls are 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 re-tested. 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 Amphetamine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).