(59 days)
The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. 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 EDDP Specific 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/Tandem Mass Spectrometry (LC-MS/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 EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
Immunalysis EDDP Urine Control Sets
The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
2. All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. 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, as well as the LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles.
The provided document describes the Immunalysis EDDP Specific Urine Enzyme Immunoassay, along with its calibrators and control sets, and the studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For qualitative results, the acceptance criterion generally implies a high level of agreement with the confirmatory method, especially around the cutoff concentrations. For semi-quantitative results, similar high agreement is expected. Precision studies demonstrate the device's ability to consistently produce the same value. Specificity and interference studies aim to show that the device accurately identifies EDDP without significant false positives or negatives due to other compounds or physiological conditions.
Below is a table summarizing the reported device performance for the Qualitative and Semi-Quantitative Method Comparison studies, which are key to assessing acceptance criteria:
Table: Acceptance Criteria and Reported Device Performance (Method Comparison)
| Study Type | Cutoff (ng/mL) | Acceptance Criteria (Implicit from FDA submission standards) | Reported Device Performance (Agreement with LC/MS) | Additional Details |
|---|---|---|---|---|
| Qualitative Method Comparison | 100 | High agreement with LC/MS across known concentrations. | 98% Agreement | One discordant case (Test Device POS, LC/MS 97.0 ng/mL, cutoff 100 ng/mL) |
| Qualitative Method Comparison | 300 | High agreement with LC/MS across known concentrations. | 100% Agreement | No discordant cases reported. |
| Qualitative Method Comparison | 1000 | High agreement with LC/MS across known concentrations. | 100% Agreement | No discordant cases reported. |
| Semi-Quantitative Method Comparison | 100 | High agreement with LC/MS across known concentrations. | 98% Agreement | One discordant case (Test Device POS, LC/MS 97.0 ng/mL, cutoff 100 ng/mL) |
| Semi-Quantitative Method Comparison | 300 | High agreement with LC/MS across known concentrations. | 100% Agreement | No discordant cases reported. |
For Precision/Cutoff Characterization, the acceptance criteria are generally that samples below the cutoff are consistently negative and samples above the cutoff are consistently positive. Samples at the cutoff are expected to show a mix of positive and negative results, indicating the cutoff acts as a boundary. The device demonstrated this behavior across all cutoffs (100, 300, 1000 ng/mL) for both qualitative and semi-quantitative analysis. For example, at the 100 ng/mL cutoff, concentrations below 100 ng/mL yielded 80 negative results out of 80 determinations, while concentrations above 100 ng/mL yielded 80 positive results out of 80 determinations. At the 100 ng/mL cutoff itself, there were a mix of positive and negative results as expected (e.g., 43 Negative / 37 Positive for qualitative, 10 Negative / 70 Positive for semi-quantitative).
The specificity and interference studies showed that many structurally non-similar compounds up to high concentrations did not interfere with the assay. Some structurally similar compounds (e.g., Methadone, Chlorpromazine, Methylphenidate, Diphenhydramine, (±)-alpha methadol) did show cross-reactivity at high concentrations, and these are noted in the labeling. Boric Acid was identified as an interferent and limitations added to the labeling. pH and Specific Gravity within tested ranges did not interfere.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison):
- For the 100 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 31)
- For the 300 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 34)
- For the 1000 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 36)
- Sample Size (Precision/Cutoff Characterization): For each cutoff (100, 300, 1000 ng/mL) and each concentration level relative to the cutoff (e.g., -100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%), there were 80 determinations (20 days, 2 runs per day, in duplicate). This results in 9 concentration levels * 80 determinations = 720 determinations per cutoff. This was done for qualitative and semi-quantitative modes.
- Data Provenance: The Method Comparison study used "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This indicates the data is retrospective and its country of origin is not explicitly stated but is implicitly from the US given the FDA submission. The other studies (Precision, Specificity, Interference, Linearity/Recovery) appear to use spiked or prepared samples, not directly from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the test set.
- Instead, the ground truth for the method comparison study was established using a "more specific alternate chemical method," specifically Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS). These are analytical laboratory techniques, not human expert interpretation.
4. Adjudication Method for the Test Set
- Since the ground truth was established by LC/MS, there was no human adjudication process described for the test set results. The device's results were directly compared to the LC/MS confirmation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic assay (an enzyme immunoassay) for the detection of EDDP in urine, not an AI-based image analysis or diagnostic tool that involves human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented is for the device operating in a standalone manner. The "Test Device" results were compared directly against the LC/MS confirmation. The assay is performed on automated clinical chemistry analyzers.
7. The Type of Ground Truth Used
- The primary ground truth used for performance verification (Method Comparison) was LC/MS (Liquid Chromatography/Tandem Mass Spectrometry) Confirmation. This is a highly accurate chemical analytical method considered the gold standard for drug confirmation.
- For other studies (Precision, Specificity, Interference, Linearity/Recovery), the ground truth was based on known concentrations of EDDP or other compounds in prepared urine matrices.
8. The Sample Size for the Training Set
- The document does not describe a "training set" in the context of machine learning or AI. This is a traditional immunoassay device. The assay development process involves optimization, but there isn't a "training set" in the way it's defined for AI/ML models. For traditional assays, development involves iterative testing and refinement of reagents and protocols using various samples, but this is distinct from training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there is no explicit "training set" in the AI/ML sense. The "ground truth" for the calibrators and controls used in the assay itself is established by spiking known concentrations of EDDP into a synthetic urine matrix and verifying these concentrations through mass spectrometry.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767
Re: K151395
Trade/Device Name: Immunalysis EDDP Specific Urine Enzyme Immunoassay. Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DLJ, LAS Dated: May 22, 2015 Received: May 26, 2015
Dear 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151395
Device Name
Immunalysis EDDP Specific Urine Enzyme Immunoassay Immunalysis EDDP Urine Calibrators Immunalysis EDDP Urine Control Sets
Indications for Use (Describe)
Immunalysis EDDP Specific Urine Enzyme Immunoassay
The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. 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 EDDP Specific 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/Tandem Mass Spectrometry (LC-MS/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 EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
Immunalysis EDDP Urine Control Sets
The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- A. Contact Information
| 1. | Manufacturer: | Immunalysis Corporation |
|---|---|---|
| 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: | July 8, 2015 |
| B. Device Information | ||
| 1. Trade Name: | Immunalysis EDDP Specific Urine Enzyme ImmunoassayImmunalysis EDDP Calibrators and Control Sets | |
| 2. | Common Name: | Immunalysis EDDP Specific Urine Enzyme ImmunoassayImmunalysis EDDP Calibrators and Control Sets |
| C. Regulatory Information | ||
| 1. Device Classification: | III, reserved | |
| 2. Regulation Number: | 21 CFR862.3250 Enzyme Immunoassay, Methadone21 CFR 862.3200 Calibrator, Drug Specific21 CFR 862.3280 Drug Specific Control Materials | |
| 3. Panel: | Toxicology(91) | |
| 4. | Product Code: | DJRDLJLAS |
- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
-
- Predicate Device: DRI® Methadone Metabolite Enzyme Immunoassay
-
- Predicate Company: Microgenics
-
- Predicate K Number: K023617
-
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- E. Device Description
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
-
- All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. 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, as well as the LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles. The concentration of EDDP in their corresponding calibrators and controls are summarized as follows:
| Analyte | EDDP Calibrators | EDDP Controls | EDDP Controls | EDDP Controls | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 4 | LOW Control 1 | HIGH Control 1 | LOW Control 2 | HIGH Control 2 | LOW Control 3 | HIGH Control 3 | |
| EDDP (ng/mL) | 100 | 300 | 500 | 1000 | 75 | 125 | 225 | 375 | 750 | 1250 |
esponding Calibrators and Controls are Summarized as follows:
Table 1: Immunoassay EDDP Urine Calibrators and Controls
F. Intended Use
- The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous 1. enzyme immunoassay with cutoffs of 100ng/mL, 300ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. The 100ng/mL and 300ng/mL cutoff is for qualitative and semi-quantitative analysis. The 1000ng/mL cutoff is for qualitative analysis only. This assay is calibrated against EDDP. 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 EDDP Specific 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
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Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/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 EDDP Urine Controls
The Immunalysis EDDP Urine Controls are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
- Immunalysis EDDP Urine Controls
-
- Immunalysis EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
- Immunalysis EDDP Urine Calibrators
| Item | EDDP Assay K023617 | Immunalysis EDDP Specific Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi-quantitative determination of thepresence of EDDP in human urine at acutoff of 300ng/mL and 1000ng/mL | For the qualitative and semi-quantitativedetermination of the presence of EDDP inhuman urine at a cutoff of 100ng/mL,300ng/mL and 1000ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| MeasuredAnalytes | EDDP | EDDP |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 300ng/mL and 1000ng/mL of EDDP | 100ng/mL, 300ng/mL and 1000ng/mL ofEDDP |
| Test System | Homogeneous Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | Antibody/Substrate Reagents andEnzyme Labeled Conjugate | Antibody/Substrate Reagents and EnzymeLabeled Conjugate |
| MassSpectroscopyConfirmation | Required for preliminary positiveanalytical results | Required for preliminary positive analyticalresults |
| Antibodv | Mouse Monoclonal antibodies toEDDP | Recombinant antibody to EDDP |
| Storage | 2 - 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Four (4) Levels | Four (4) Levels |
| Control Levels | Four (4) Levels | Six (6) Levels |
G. Comparison of the new device with the predicate device
- H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis EDDP Specific Urine Enzyme Immunoassay to the predicate
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IMMUNALYSIS
-
- Precision/ Cutoff Characterization/ Reproducibility 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 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.
| a. The following is a summary table of the Qualitative Analysis for the |
|---|
| 100ng/mL cutoff test data results. |
| Table 2 - Qualitative Analysis (for 100ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 25 | -75% | 80 | 80 Negative |
| 50 | -50% | 80 | 80 Negative |
| 75 | -25% | 80 | 80 Negative |
| 100 | Cutoff | 80 | 43 Negative/37 Positive |
| 125 | +25% | 80 | 80 Positive |
| 150 | +50% | 80 | 80 Positive |
| 175 | +75% | 80 | 80 Positive |
| 200 | +100% | 80 | 80 Positive |
b. The following is a summary table of the Qualitative Analysis for the 300ng/mL cutoff test data results.
| Table 3 - Qualitative Analysis (for 300 ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 40 Negative / 40 Positive |
| 375 | +25% | 80 | 80 Positive |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
c. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results.
| Table 4 - 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 | 46 Negative / 34 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
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| Table 5 - Semi-Quantitative Analysis (for 100ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 25 | -75% | 80 | 80 Negative |
| 50 | -50% | 80 | 80 Negative |
| 75 | -25% | 80 | 80 Negative |
| 100 | Cutoff | 80 | 10 Negative / 70 Positive |
| 125 | +25% | 80 | 80 Positive |
| 150 | +50% | 80 | 80 Positive |
| 175 | +75% | 80 | 80 Positive |
| 200 | +100% | 80 | 80 Positive |
d. The following is a summary table of the Semi-Quantitative Analysis for the 100ng/mL cutoff test data results.
e. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results.
| Table 6 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 13 Negative / 67 Positive |
| 375 | +25% | 80 | 80 Positive |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
-
- 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 100ng/mL cutoff is outlined below:
| Table 7 - Structurally Related Compounds (for 100 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| EDDP | 100 | Positive | 100 |
| Methadone | 700,000 | Positive | 0.01 |
| EMDP | 1,000,000 | Negative | <0.01 |
| Chlorpromazine | 90,000 | Positive | 0.11 |
| Diphenhydramine | 1,000,000 | Positive | 0.01 |
| Methylphenidate | 100,000 | Positive | 0.10 |
| Doxylamine | 1,000,000 | Negative | <0.01 |
| LAAM | 1,000,000 | Negative | <0.01 |
| (±)-alpha methadol | 1,000,000 | Positive | 0.01 |
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| Table 7 - Structurally Related Compounds (for 100 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (-)-iso-methadone | 100,000 | Negative | <0.1 |
b. The qualitative result summary table for the 300ng/mL cutoff is outlined below:
| Table 8 - Structurally Related Compounds (for 300 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| EDDP | 300 | Positive | 100 |
| Methadone | 1,000,000 | Negative | <0.03 |
| EMDP | 1,000,000 | Negative | <0.03 |
| Chlorpromazine | 300,000 | Positive | 0.1 |
| Diphenhydramine | 1,000,000 | Negative | <0.03 |
| Methylphenidate | 360,000 | Positive | 0.08 |
| Doxylamine | 1,000,000 | Negative | <0.03 |
| LAAM | 1,000,000 | Negative | <0.03 |
| (±)-alpha methadol | 1,000,000 | Negative | <0.03 |
| (-)-iso-methadone | 100,000 | Negative | <0.3 |
- c. The semi-quantitative result summary table for the 1000ng/mL cutoff is outlined below:
| Table 9 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| EDDP | 1,000 | Positive | 100 |
| Methadone | 1,000,000 | Negative | <0.1 |
| EMDP | 1,000,000 | Negative | <0.1 |
| Chlorpromazine | 1,000,000 | Negative | <0.1 |
| Diphenhydramine | 1,000,000 | Negative | <0.1 |
| Methylphenidate | 1,000,000 | Negative | <0.1 |
| Doxylamine | 1,000,000 | Negative | <0.1 |
| LAAM | 1,000,000 | Negative | <0.1 |
| (±)-alpha methadol | 1,000,000 | Negative | <0.1 |
| (-)-iso-methadone | 100,000 | Negative | <1.0 |
- d. The semi-quantitative result summary table for the 100ng/mL cutoff is outlined below:
| Table 10 - Structurally Related Compounds (for 100ng/mL cutoff) - Semi- | ||||
|---|---|---|---|---|
| Quantitative | ||||
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | |
| EDDP | 100 | Positive | 100 | |
| Methadone | 700.000 | Positive | 0.01 | |
| EMDP | 1,000,000 | Negative | <0.01 | |
| Chlorpromazine | 90,000 | Positive | 0.11 | |
| Diphenhydramine | 1,000,000 | Positive | 0.01 | |
| Methylphenidate | 100,000 | Positive | 0.10 | |
| Doxylamine | 1,000,000 | Negative | <0.01 |
{9}------------------------------------------------
Image /page/9/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.
| Table 10 - Structurally Related Compounds (for 100ng/mL cutoff) – Semi- | |||
|---|---|---|---|
| Quantitative | |||
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| LAAM | 1,000,000 | Negative | <0.01 |
| (±)-alpha methadol | 1,000,000 | Positive | 0.0001 |
| (-)-iso-methadone | 100,000 | Negative | <0.1 |
- e. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below:
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
|---|---|---|---|
| EDDP | 300 | Positive | 100 |
| Methadone | 1,000,000 | Negative | <0.03 |
| EMDP | 1,000,000 | Negative | <0.03 |
| Chlorpromazine | 300,000 | Positive | 0.1 |
| Diphenhydramine | 1,000,000 | Negative | <0.03 |
| Methylphenidate | 360,000 | Positive | 0.08 |
| Doxylamine | 1,000,000 | Negative | <0.03 |
| LAAM | 1,000,000 | Negative | <0.03 |
| (±)-alpha methadol | 1,000,000 | Negative | <0.03 |
| (-)-iso-methadone | 100,000 | Negative | <0.3 |
-
- 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 table of the structurally non-similar compounds for the 100ng/mL cutoff:
| Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Concentration | -25% Cutoff | +25% Cutoff | |||
| Compound | Tested | (75ng/mL) | (125ng/mL) | ||
| (ng/mL) | Result | Interference? | Result | Interference? | |
| 4-bromo 2-5,dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicylic Acid | 500,000 | Negative | No | Positive | No |
| 6-Acetylcodeine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminoflurnitrazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminonitrazepam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | |||||
| Concentration | -25% Cutoff | +25% Cutoff | |||
| Compound | Tested | (75ng/mL) | (125ng/mL) | ||
| (ng/mL) | Result | Interference? | Result | Interference? | |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| S-(+)-Amphetamine | 100,000 | 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 |
| Butalbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 500,000 | Negative | No | Positive | No |
| Cannabidiol | 100,000 | Negative | No | Positive | No |
| Cannabinol | 75,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Carisoprodol | 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 | 50,000 | Negative | No | Positive | No |
| Clonazepam | 100,000 | Negative | No | Positive | No |
| Clozapine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cotinine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| Dehydronorketamine | 100,000 | Negative | No | Positive | No |
| Demoxepam | 100,000 | Negative | No | Positive | No |
| Desipramine | 30,000 | Negative | No | Positive | No |
| Desalkylflurazepam | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Digoxin | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| v, THC | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| 1R,2S (-) Ephedrine | 100,000 | Negative | No | Positive | No |
| 1S,2R (+) Ephedrine | 100,000 | Negative | No | Positive | No |
| Ethyl-ß-D-Glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Fenfluramine | 100,000 | Negative | No | Positive | No |
| Fentanyl | 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 |
| Haloperidol | 100,000 | Negative | No | Positive | No |
| Heroin | 100,000 | Negative | No | Positive | No |
| Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(75ng/mL)Result | -25% Cutoff(75ng/mL)Interference? | +25% Cutoff(125ng/mL)Result | +25% Cutoff(125ng/mL)Interference? |
| Hexobarbital | 100,000 | Negative | No | Positive | No |
| Hydrocodone | 100,000 | Negative | No | Positive | No |
| Hydromorphone | 100,000 | Negative | No | Positive | No |
| 11-hydroxy- Δ9 THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 500,000 | Negative | No | Positive | No |
| Imipramine | 50,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Lamotrigine | 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 |
| Lorazepam Glucuronide | 50,000 | Negative | No | Positive | No |
| Lormetrazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| (+)-MDA | 100,000 | Negative | No | Positive | No |
| MDEA | 100,000 | Negative | No | Positive | No |
| MDMA | 100,000 | Negative | No | Positive | No |
| Meperidine | 50,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| S(+)-Methamphetamine | 100,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methoxetamine | 100,000 | Negative | No | Positive | No |
| Methylone | 100,000 | Negative | No | Positive | No |
| Midazolam | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-3β-D-Glucuronide | 100,000 | Negative | No | Positive | No |
| Morphine-6β-D-Glucuronide | 50,000 | Negative | No | Positive | No |
| N-Desmethyltapentadol | 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 |
| Naproxen | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| 11-nor-9-carboxy -Δ9-THC | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 50,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Norketamine | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norproxyphene | 100,000 | Negative | No | Positive | No |
| Norpseudoephedrine | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(75ng/mL)Result | -25% Cutoff(75ng/mL)Interference? | +25% Cutoff(125ng/mL)Result | +25% Cutoff(125ng/mL)Interference? |
| Olanzapine | 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 | 50,000 | 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 |
| Phentermine | 100,000 | Negative | No | Positive | No |
| Phenylephedrine | 100,000 | Negative | No | Positive | No |
| Phenylpropanolamine | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| PMA | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propoxyphene | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| R,R (+)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| S,S (-)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Salicylic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbital | 100,000 | Negative | No | Positive | No |
| Sertraline | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 50,000 | Negative | No | Positive | No |
| Tapentadol | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| Theophylline | 100,000 | Negative | No | Positive | No |
| Thioridazine | 30,000 | Negative | No | Positive | No |
| Trazodone | 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 |
| Verapamil | 100,000 | Negative | No | Positive | No |
| Zolpidem Tartrate | 100,000 | Negative | No | Positive | No |
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Image /page/10/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a three-dimensional appearance. The red background is a solid color, and the overall image has a simple, clean design.
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Image /page/11/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a soft appearance. The red background is a solid color, providing a strong contrast to the white text.
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Image /page/12/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a three-dimensional appearance. The red background is a solid color, and the overall image has a simple, clean design.
{13}------------------------------------------------
Image /page/13/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 font is bold and sans-serif. The red background is a solid color.
- b. The following is a table of the structurally non-similar compounds for the 300ng/mL cutoff:
| Table 13 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| 4-bromo 2-5,dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicylic Acid | 500,000 | Negative | No | Positive | No |
| 6-Acetylcodeine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminoflurnitrazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminonitrazepam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| S-(+)-Amphetamine | 100,000 | 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 |
| Butalbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 500,000 | Negative | No | Positive | No |
| Cannabidiol | 100,000 | Negative | No | Positive | No |
| Cannabinol | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Carisoprodol | 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 |
| Clozapine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cotinine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| Dehydronorketamine | 100,000 | Negative | No | Positive | No |
| Demoxepam | 100,000 | Negative | No | Positive | No |
| Desipramine | 100,000 | Negative | No | Positive | No |
| Desalkylflurazepam | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Digoxin | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| Table 13 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | |||||
| Concentration | -25% Cutoff | +25% Cutoff | |||
| Compound | Tested | (225ng/mL) | (375ng/mL) | ||
| (ng/mL) | Result | Interference? | Result | Interference? | |
| Δ⁹ THC | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| 1R,2S (-) Ephedrine | 100,000 | Negative | No | Positive | No |
| 1S,2R (+) Ephedrine | 100,000 | Negative | No | Positive | No |
| Ethyl-β-D-Glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Fenfluramine | 100,000 | Negative | No | Positive | No |
| Fentanyl | 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 |
| Haloperidol | 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- Δ⁹ THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 500,000 | Negative | No | Positive | No |
| Imipramine | 100,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Lamotrigine | 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 |
| Lorazepam Glucuronide | 50,000 | Negative | No | Positive | No |
| Lormetrazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| (+)-MDA | 100,000 | Negative | No | Positive | No |
| MDEA | 100,000 | Negative | No | Positive | No |
| MDMA | 100,000 | Negative | No | Positive | No |
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| S(+)-Methamphetamine | 100,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methoxetamine | 100,000 | Negative | No | Positive | No |
| Methylone | 100,000 | Negative | No | Positive | No |
| Midazolam | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-3β-D-Glucuronide | 100,000 | Negative | No | Positive | No |
| Morphine-6β-D-Glucuronide | 50,000 | Negative | No | Positive | No |
| N-Desmethyltapentadol | 100,000 | Negative | No | Positive | No |
| Nalorphine | 100,000 | Negative | No | Positive | No |
| Table 13 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Naloxone | 100,000 | Negative | No | Positive | No |
| Naltrexone | 100,000 | Negative | No | Positive | No |
| Naproxen | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| 11-nor-9-carboxy -Δ9-THC | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 50,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Norketamine | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norproxyphene | 100,000 | Negative | No | Positive | No |
| Norpseudoephedrine | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Olanzapine | 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 |
| Phentermine | 100,000 | Negative | No | Positive | No |
| Phenylephedrine | 100,000 | Negative | No | Positive | No |
| Phenylpropanolamine | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| PMA | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propoxyphene | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| R,R (+)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| S,S (-)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Salicylic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbital | 100,000 | Negative | No | Positive | No |
| Sertraline | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 50,000 | Negative | No | Positive | No |
| Tapentadol | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| Theophylline | 100,000 | Negative | No | Positive | No |
| Thioridazine | 100,000 | Negative | No | Positive | No |
| Trazodone | 100,000 | Negative | No | Positive | No |
| Table 13 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| 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 |
| Verapamil | 100,000 | Negative | No | Positive | No |
| Zolpidem Tartrate | 100,000 | Negative | No | Positive | No |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters with a red background. The letters are bold and slightly blurred, giving them a three-dimensional appearance. The word is centered in the image and takes up most of the space.
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Image /page/15/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a three-dimensional appearance. The red background is a solid color, and the overall image has a simple, clean design.
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Image /page/16/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.
c. The following is a table of the structurally non-similar compounds for the 1000ng/mL cutoff:
| Table 14 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| ConcentrationTested(ng/mL) | -25% Cutoff(750ng/mL) | +25% Cutoff(1250ng/mL) | |||
| Compound | Result | Interference? | Result | Interference? | |
| 4-bromo 2-5,dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicylic Acid | 500,000 | Negative | No | Positive | No |
| 6-Acetylcodeine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminoflurnitrazepam | 100,000 | Negative | No | Positive | No |
| 7-Aminonitrazepam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| S-(+)-Amphetamine | 100,000 | 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 |
| Butalbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 500,000 | Negative | No | Positive | No |
| Cannabidiol | 100,000 | Negative | No | Positive | No |
| Cannabinol | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Carisoprodol | 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 |
| Table 14 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(750ng/mL) | +25% Cutoff(1250ng/mL) | ||
| Result Interference? | Result Interference? | ||||
| Clozapine | 100,000 | Negative No | Positive No | ||
| Codeine | 100,000 | Negative No | Positive No | ||
| Cotinine | 100,000 | Negative No | Positive No | ||
| Cyclobenzaprine | 100,000 | Negative No | Positive No | ||
| Dehydronorketamine | 100,000 | Negative No | Positive No | ||
| Demoxepam | 100,000 | Negative No | Positive No | ||
| Desipramine | 100,000 | Negative No | Positive No | ||
| Desalkylflurazepam | 100,000 | Negative No | Positive No | ||
| Dextromethorphan | 100,000 | Negative No | Positive No | ||
| Diazepam | 100,000 | Negative No | Positive No | ||
| Digoxin | 100,000 | Negative No | Positive No | ||
| Dihydrocodeine | 100,000 | Negative No | Positive No | ||
| Δ9 THC | 100,000 | Negative No | Positive No | ||
| Doxepin | 100,000 | Negative No | Positive No | ||
| 1R,2S (-) Ephedrine | 100,000 | Negative No | Positive No | ||
| 1S,2R (+) Ephedrine | 100,000 | Negative No | Positive No | ||
| Ethyl-β-D-Glucuronide | 100,000 | Negative No | Positive No | ||
| Ethylmorphine | 100,000 | Negative No | Positive No | ||
| Fenfluramine | 100,000 | Negative No | Positive No | ||
| Fentanyl | 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 | ||
| Haloperidol | 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- Δ9 THC | 100,000 | Negative No | Positive No | ||
| Ibuprofen | 500,000 | Negative No | Positive No | ||
| Imipramine | 100,000 | Negative No | Positive No | ||
| Ketamine | 100,000 | Negative No | Positive No | ||
| Lamotrigine | 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 | ||
| Lorazepam Glucuronide | 50,000 | Negative No | Positive No | ||
| Lormetrazepam | 100,000 | Negative No | Positive No | ||
| LSD | 100,000 | Negative No | Positive No | ||
| Maprotiline | 100,000 | Negative No | Positive No | ||
| (+)-MDA | 100,000 | Negative No | Positive No | ||
| MDEA | 100,000 | Negative No | Positive No | ||
| MDMA | 100,000 | Negative No | Positive No | ||
| Table 14 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(750ng/mL) | +25% Cutoff(1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| S(+)-Methamphetamine | 100,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methoxetamine | 100,000 | Negative | No | Positive | No |
| Methylone | 100,000 | Negative | No | Positive | No |
| Midazolam | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-3ß-D-Glucuronide | 100,000 | Negative | No | Positive | No |
| Morphine-6ß-D-Glucuronide | 50,000 | Negative | No | Positive | No |
| N-Desmethyltapentadol | 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 |
| Naproxen | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| 11-nor-9-carboxy -Δ9-THC | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 50,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Norketamine | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norproxyphene | 100,000 | Negative | No | Positive | No |
| Norpseudoephedrine | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Olanzapine | 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 |
| Phentermine | 100,000 | Negative | No | Positive | No |
| Phenylephedrine | 100,000 | Negative | No | Positive | No |
| Phenylpropanolamine | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| PMA | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propoxyphene | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| R,R (+)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| Table 14 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | |||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(750ng/mL) | +25% Cutoff(1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| S,S (-)- Pseudoephedrine | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Salicylic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbital | 100,000 | Negative | No | Positive | No |
| Sertraline | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 50,000 | Negative | No | Positive | No |
| Tapentadol | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| Theophylline | 100,000 | Negative | No | Positive | No |
| Thioridazine | 100,000 | Negative | No | Positive | No |
| Trazodone | 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 |
| Verapamil | 100,000 | Negative | No | Positive | No |
| Zolpidem Tartrate | 100,000 | Negative | No | Positive | No |
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- d. Concentrations above the following may result in a falsely low test result for the 100ng/mL cutoff: Cannabinol at 75,000. Concentrations above the following may result may result in a falsely high test result for the 100ng/mL cutoff: Desipramine at 30,000, Clomipramine and Imipramine at 50,000, Meperidine at 50,000, PCP at 50,000 and Thiordazine at 30,000. The limitations have been added to the labeling regarding these compounds.
- e. The following is a table of the endogenous compounds results for the 100ng/mL cutoff:
| Table 15 - Endogenous Compounds (for 100ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff (75ng/mL) | +25% Cutoff (125ng/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 | 0.300 g/dL | Negative | No | Positive | No |
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| Table 15 - Endogenous Compounds (for 100ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff (75ng/mL) | +25% Cutoff (125ng/mL) | ||||
| Compound | Concentration Tested (ng/mL) | Result | Interference? | Result | Interference? |
| 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 Fluoride | 1% w/v | Negative | No | Positive | No |
| Urea | 6.0 g/dL | Negative | No | Positive | No |
f. The following is a table of the endogenous compounds results for the 300ng/mL cutoff:
| Table 16 - Endogenous Compounds (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Concentration | -25% Cutoff | +25% Cutoff | |||
| Compound | Tested | (225ng/mL) | (375ng/mL) | ||
| (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 | 0.300 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 Fluoride | 1% w/v | Negative | No | Positive | No |
| Urea | 6.0 g/dL | Negative | No | Positive | No |
g.The following is a table of the endogenous compounds results for the 1000ng/mL cutoff:
| Table 17 - Endogenous Compounds (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (750ng/mL) Result | -25% Cutoff (750ng/mL) Interference? | +25% Cutoff (1250ng/mL) Result | +25% Cutoff (1250ng/mL) 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 |
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Image /page/21/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 red background is a solid color, and the white letters are easy to read. The image is simple and straightforward, with a clear message.
| Table 17 - Endogenous Compounds (for 1000ng/mL cutoff) | |||||||
|---|---|---|---|---|---|---|---|
| Concentration | -25% Cutoff | +25% Cutoff | |||||
| Compound | Tested | (750ng/mL) | (1250ng/mL) | ||||
| (ng/mL) | Result | Interference? | Result | Interference? | |||
| y-Globulin | 0.5 g/dL | Negative | No | Positive | No | ||
| Glucose | 2.0 g/dL | Negative | No | Positive | No | ||
| Hemoglobin | 0.300 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 Fluoride | 1% w/v | Negative | No | Positive | No | ||
| Urea | 6.0 g/dL | Negative | No | Positive | No | ||
| h.The following is a table of the Boric Acid for the 100ng/mL cutoff | |||||||
| results: | |||||||
| Table 18 - Boric Acid (for 100ng/mL cutoff) | |||||||
| Concentration | -25% Cutoff (75ng/mL) | +25% Cutoff(125ng/mL) | |||||
| Compound | Tested | ||||||
| (ng/mL) | Result | Interference? | Result | Interference? | |||
| Boric Acid | 1% w/v | Negative | No | Negative | Yes | ||
| The following is a table of the Boric Acid for the 300ng/mL cutoffi. | |||||||
| results: | |||||||
| Table 19 - Boric Acid (for 300ng/mL cutoff) | |||||||
| Concentration | -25% Cutoff | +25% Cutoff | |||||
| Compound | Tested | (225ng/mL) | (375ng/mL) | ||||
| (ng/mL) | Result | Interference? | Result | Interference? | |||
| Boric Acid | 1% w/v | Negative | No | Negative | Yes | ||
| 1. | The following is a table of the Boric Acid for the 1000ng/mL cutoff | ||||||
| results: | |||||||
| Table 20 - Boric Acid (for 1000ng/mL cutoff) | |||||||
| Concentration | -25% Cutoff | +25% Cutoff | |||||
| Compound | Tested | (750ng/mL) | (1250ng/mL) | ||||
| (ng/mL) | Result | Interference? | Result | Interference? | |||
| Boric Acid | |||||||
| 1% w/v | Negative | No | Negative | Yes | |||
| k. The following is a table of the Boric Acid for the 100ng/mL cutoff results: | |||||||
| Table 21 - Boric Acid (for 100ng/mL cutoff) | |||||||
| Concentration | -50% Cutoff | +50% Cutoff | |||||
| Compound | Tested | (50ng/mL) | (150ng/mL) | ||||
| Boric Acid | (ng/mL)1% w/v | ResultNegative | Interference?No | ResultPositive | Interference?No |
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| results: | |||||
|---|---|---|---|---|---|
| Table 22 - Boric Acid (for 300ng/mL cutoff) | |||||
| Concentration | -50% Cutoff | +50% Cutoff | |||
| Compound | Tested | (150ng/mL) | (450ng/mL) | ||
| (ng/mL) | Result | Interference? | Result | Interference? | |
| Boric Acid | 1% w/v | Negative | No | Positive | No |
-
- The following is a table of the Boric Acid for the 300ng/mL cutoff
m. The following is a table of the Boric Acid for the 1000ng/mL cutoff results:
- The following is a table of the Boric Acid for the 300ng/mL cutoff
| -50% Cutoff(500ng/mL) | +50% Cutoff(1500ng/mL) | ||||
|---|---|---|---|---|---|
| Table 23 – Boric Acid (for 1000ng/mL cutoff) | |||||
| Compound | Concentration Tested(ng/mL) | Result | Interference? | Result | Interference? |
| Boric Acid | 1% w/v | Negative | No | Positive | No |
n. Boric Acid interferes with the assay and the limitations have been added to the labeling regarding this compound.
o. The following is table of the effect of pH results for the 100ng/mL cutoff:
| Table 24 - Effect of pH (for 100ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff(75ng/mL) | +25% Cutoff(125ng/mL) | ||||
| Test Parameter | Value | Result | Interference? | Result | Interference? |
| pH | 3.0 | NEG | No | POS | No |
| pH | 4.0 | NEG | No | POS | No |
| pH | 5.0 | NEG | No | POS | No |
| pH | 6.0 | NEG | No | POS | No |
| pH | 7.0 | NEG | No | POS | No |
| pH | 8.0 | NEG | No | POS | No |
| pH | 9.0 | NEG | No | POS | No |
| pH | 10.0 | NEG | No | POS | No |
| pH | 11.0 | NEG | No | POS | No |
p. The following is table of the effect of pH results for the 300ng/mL cutoff:
| Table 25 - Effect of pH (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| pH | 3.0 | NEG | No | POS | No |
| pH | 4.0 | NEG | No | POS | No |
| pH | 5.0 | NEG | No | POS | No |
| pH | 6.0 | NEG | No | POS | No |
| pH | 7.0 | NEG | No | POS | No |
| pH | 8.0 | NEG | No | POS | No |
| pH | 9.0 | NEG | No | POS | No |
| pH | 10.0 | NEG | No | POS | No |
| pH | 11.0 | NEG | No | POS | No |
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| Table 26 - 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 | NEG | No | POS | No |
| pH | 4.0 | NEG | No | POS | No |
| pH | 5.0 | NEG | No | POS | No |
| pH | 6.0 | NEG | No | POS | No |
| pH | 7.0 | NEG | No | POS | No |
| pH | 8.0 | NEG | No | POS | No |
| pH | 9.0 | NEG | No | POS | No |
| pH | 10.0 | NEG | No | POS | No |
| pH | 11.0 | NEG | No | POS | No |
- q. The following is a table of the effect of pH results for the 1000ng/mL cutoff:
- r. The following is a table of the effect of specific gravity results for the 100ng/mL cutoff:
| Table 27 - Effect of Specific Gravity (for 100ng/mL cutoff) | -25% Cutoff(75ng/mL) | +25% Cutoff(125ng/mL) | |||
|---|---|---|---|---|---|
| Test Parameter | Value | Result | Interference? | Result | Interference? |
| Specific Gravity | 1.000 | NEG | No | POS | No |
| Specific Gravity | 1.002 | NEG | No | POS | No |
| Specific Gravity | 1.005 | NEG | No | POS | No |
| Specific Gravity | 1.010 | NEG | No | POS | No |
| Specific Gravity | 1.015 | NEG | No | POS | No |
| Specific Gravity | 1.020 | NEG | No | POS | No |
| Specific Gravity | 1.025 | NEG | No | POS | No |
| Specific Gravity | 1.030 | NEG | No | POS | No |
s. The following is a table of the effect of specific gravity results for the 300ng/mL cutoff:
| Table 28 - Effect of Specific Gravity (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Specific Gravity | 1.000 | NEG | No | POS | No |
| Specific Gravity | 1.002 | NEG | No | POS | No |
| Specific Gravity | 1.005 | NEG | No | POS | No |
| Specific Gravity | 1.010 | NEG | No | POS | No |
| Specific Gravity | 1.015 | NEG | No | POS | No |
| Specific Gravity | 1.020 | NEG | No | POS | No |
| Specific Gravity | 1.025 | NEG | No | POS | No |
| Specific Gravity | 1.030 | NEG | No | POS | No |
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| Table 29 - Effect of Specific Gravity (for 1000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Test Parameter | Value | -25% Cutoff(750ng/mL) | +25% Cutoff(1250ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Specific Gravity | 1.000 | NEG | No | POS | No |
| Specific Gravity | 1.002 | NEG | No | POS | No |
| Specific Gravity | 1.005 | NEG | No | POS | No |
| Specific Gravity | 1.010 | NEG | No | POS | No |
| Specific Gravity | 1.015 | NEG | No | POS | No |
| Specific Gravity | 1.020 | NEG | No | POS | No |
| Specific Gravity | 1.025 | NEG | No | POS | No |
| Specific Gravity | 1.030 | NEG | No | POS | No |
t. The following is a table of the effect of specific gravity results for the 1000ng/mI_cutoff
-
- 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 30 - Linearity/ Recovery | ||
|---|---|---|
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
| 0 | 2.3 | N/A |
| 100 | 109.5 | 109.5 |
| 200 | 203.8 | 101.9 |
| 300 | 292.7 | 97.6 |
| 400 | 413.4 | 103.4 |
| 500 | 492.2 | 98.4 |
| 600 | 638.0 | 106.3 |
| 700 | 746.0 | 106.6 |
| 800 | 833.7 | 104.2 |
| 900 | 926.1 | 102.9 |
| 1000 | 980.0 | 98.0 |
| 1100 | 1037.8 | 94.3 |
a. The following is a summary table of the linearity/recovery:
b. The Linearity/Recovery study has successfully verified that the product performance can meet the design specifications regarding assay performance in the semi-quantitative mode
-
- 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.
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- a. The following is a comparison table of qualitative assay performance for the 100ng/mL cutoff:
Table 31 - Method Comparison (for 100ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 1 |
| (-) | 0 | 39 |
- b. The following is a summary table of qualitative assay performance for the 100ng/mL cutoff:
| Table 32 - Assay Performance verified by LC/MS – 100ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| EDDP Concentration | Agreement | ||||
| Type | < 50ng/mL | 50~99 ng/mL | 100~150 ng/mL | > 150 ng/mL | (%) |
| Qualitative/Positive | 0 | 1 | 4 | 36 | 98 |
| Qualitative/Negative | 36 | 3 | 0 | 0 | 100 |
c. The following is a summary table of qualitative discordant results for the 100ng/mL cutoff:
| Sample ID | In-House ID | Qualitative Results 100ng CutoffTest Device | LC/MS ConfirmationEDDP |
|---|---|---|---|
| JM042877 | 15980 | POS | 97.0 |
d. The following is a comparison table of qualitative assay performance for the 300ng/mL cutoff:
- Table 34 Method Comparison (for 300ng/mL cutoff) Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 0 | 40 |
- e. The following is a summary table of the qualitative assay performance for the 300ng/mL cutoff:
| Table 35 - Assay Performance verified by LC/MS – 300ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | EDDP Concentration | Agreement (%) | |||
| < 150ng/mL | 150 ~ 299 ng/mL | 300 ~ 450 ng/mL | > 450 ng/mL | ||
| Qualitative/Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/Negative | 36 | 4 | 0 | 0 | 100 |
f. The following is a comparison table of qualitative assay performance for the 1000ng/mL cutoff:
Table 36 - Method Comparison (for 1000ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 0 | 40 |
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| for the 1000ng/mL cutoff: | |||||
|---|---|---|---|---|---|
| Table 37 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff | |||||
| Type | EDDP Concentration | Agreement(%) | |||
| < 500ng/mL | 500 ~ 999 ng/mL | 1000 ~ 1500 ng/mL | > 1500 ng/mL | ||
| Qualitative/Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/Negative | 36 | 4 | 0 | 0 | 100 |
- g. The following is a summary table of the qualitative assay performance
- h. The following is a comparison table of semi-quantitative assay performance for the 100ng/mL cutoff:
Table 38 - Method Comparison (for 100ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 1 |
| (-) | 0 | 39 |
i. The following is a summary table of semi-quantitative assay performance for the 100ng/mL cutoff:
| Type | EDDP Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| < 50ng/mL | 50 ~ 99 ng/mL | 100 ~ 150 ng/mL | > 150 ng/mL | ||
| Semi-Quantitative/Positive | 0 | 1 | 4 | 36 | 98 |
| Semi-Quantitative /Negative | 36 | 3 | 0 | 0 | 100 |
- j. The following is a summary table of semi-quantitative assay performance for the 100ng/mL:
| Table 40 - Discordant Result Summary – 100ng/mL Cutoff - Semi-Quantitative | ||||
|---|---|---|---|---|
| Sample ID | In-House ID | Semi-Quantitative Results100ng Cutoff | LC/MS Confirmation | |
| Value | Result | EDDP | ||
| JM042877 | 15980 | 149.5 | POS | 97.0 |
k.The following is a comparison table of semi-quantitative assay performance for the 300ng/mL cutoff:
Table 41 - Method Comparison (for 300ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 0 | 40 |
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| Type | EDDP Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| < 150ng/mL | 150 ~ 299 ng/mL | 300 ~ 450 ng/mL | > 450 ng/mL | ||
| Semi-Quantitative/Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative /Negative | 36 | 4 | 0 | 0 | 100 |
-
- The following is a summary table of semi-quantitative assay performance
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 at 2 - 8°C for reagents. The instrument used for this test was Beckman Coulter AU 400e. Real stability studies are ongoing.
- b.An open vial 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 at 2 - 8°C for reagents. The instrument used for this test was Beckman Coulter AU 400e. Real stability studies are ongoing.
- c. 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 at 2 – 8°C. The instrument used for this test was Beckman Coulter AU 400e.
-
- Calibrator and Control Analytical Performance Immunalysis EDDP Urine Calibrators and Controls
- a. EDDP Calibrators and Controls Traceability all components of the calibrators and controls have been traced to a commercially available standard solution.
- b. EDDP Calibrators and Controls Open Vial Stability An open vial accelerated stability study was performed at 37℃ to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 1 year at 2 - 8°C for calibrators and controls. 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) and all control levels (Low Control 1, 2, and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0. 3. 7. 10. and 13. This stability study was performed to establish initial expiration dating.
- c. EDDP Calibrators and Controls Closed Vial Upright Stability A closed vial upright accelerated stability study was performed at 37℃ to establish the initial vial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for calibrators and controls. 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) and all control levels (Low Control 1, 2,
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and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0, 3, 7, 10, and 13. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- d. EDDP Calibrators and Controls Closed Vial Inverted Stability A closed vial inverted accelerated stability study was performed at 37°C to establish the initial vial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for calibrators and controls. 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) and all control levels (Low Control 1, 2, and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0. 3. 7. 10. and 13. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- e. EDDP Calibrators and Controls Value Assignment Calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrator and controls is adjusted and re-tested. Values are assigned to the calibrators and controls once the mass spectrometry results are within the acceptable ranges.
- I. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis EDDP Specific Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).