(136 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic test used to detect methadone metabolite in urine, providing an analytical result, not a therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test." It is designed to determine the presence and quantity of Methadone Metabolite in human urine, which is a diagnostic function.
No
The device is an in vitro diagnostic test kit consisting of liquid reagents, calibrators, and controls, designed for use on automated clinical chemistry analyzers. It is a chemical assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test.
- Purpose: The test is intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. This is a diagnostic purpose, providing information about the presence and concentration of a substance in a biological sample.
- Sample Type: It uses human urine, which is a biological specimen.
- Method: It employs an enzyme immunoassay, which is a common in vitro diagnostic technique.
- Regulatory Context: The mention of "prescription use" and "automated clinical chemistry analyzers" indicates that this device is intended for use in a clinical laboratory setting under professional supervision, which is typical for IVDs.
- Predicate Device: The inclusion of a predicate device (K031797) further confirms its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
Therefore, based on the provided information, the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.
Product codes (comma separated list FDA assigned to the subject device)
DJR, DJR, DLJ
Device Description
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between EDDP in the sample and EDDP labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the EDDP concentration in the sample is measured in terms of enzyme activity. In the absence of EDDP in the sample, EDDP-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free EDDP is present in the sample, antibody would bind to free EDDP; the unbound EDDP-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains mouse monoclonal anti-methadone metabolite antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with methadone metabolite in buffer with sodium azide (0.09 %) as a preservative.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 250, 500 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0, 150, 225, 300, 375, 600, and 1000 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories, prescription use on automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics Summary: Beckman Coulter AU480 Analyzer
Precision: 100 ng/mL Cutoff
Semi-Quantitative Precision Analysis Summary: Qualitative Results and Semi-Quantitative Positive/Negative Results were provided.
Qualitative Positive/Negative Results for 100 ng/mL Cutoff:
Within Run (N=22), Total Precision (N=88) for concentrations 0, 25, 50, 75, 100, 125, 150, 175, 200 ng/mL.
Precision: 300 ng/mL Cutoff
Semi-Quantitative Precision Analysis Summary: Qualitative Results and Semi-Quantitative Positive/Negative Results were provided.
Qualitative Positive/Negative Results for 300 ng/mL Cutoff:
Within Run (N=22), Total Precision (N=88) for concentrations 0, 75, 150, 225, 300, 375, 450, 525, 600 ng/mL.
Method Comparison - Clinical Samples
87 clinical unaltered samples for 100 ng/mL Cutoff and 84 for 300 ng/mL Cutoff.
Qualitative Accuracy Study and Semi-Quantitative Accuracy Study were performed.
For 100 ng/mL cutoff, 2 discordant samples were identified and confirmed by LC/MS.
Cross-reactivity:
100 ng/mL Cutoff and 300 ng/mL Cutoff tested with EDDP, EMDP, Methadone, LAAM HCl, (±)-α-Methadol, (-)-Isomethadone HCl, (-)-α-Noracetylmethadol (Nor-LAAM) HCl.
Endogenous Compound Interference & Specific Gravity:
No significant undesired cross-reactants or endogenous substance interference was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2017
LIN-ZHI INTERNATIONAL, INC. BERNICE LIN VP OPERATIONS 2945 OAKMEAD VILLAGE COURT SANTA CLARA CA 95051
Re: K170416
Trade/Device Name: LZI Methadone Metabolite (EDDP) Enzyme Immunoassay, LZI Methadone Metabolite (EDDP) (100 And 300) Calibrators Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DJR, DLJ Dated: May 24, 2017 Received: May 25, 2017
Dear Ms. Lin:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/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
2
Indications for Use
510(k) Number (if known) K170416
Device Name
LZI Methadone Metabolite (EDDP) Enzyme Immunoassay The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators
Indications for Use (Describe)
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the and semi-quantitative modes of the assay are 100 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternistry method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semiquantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.
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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3
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitted On
February 9, 2017
Last Updated On
June 26, 2017
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Name, Address, and Contact:
Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, CA 95051 Phone: (408) 970-8811 (408) 970-9030 Fax: e-mail: bclin@lin-zhi.com
Bernice Lin, Ph.D. Contact: VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Methadone Metabolite
Class II, DJR (91 Toxicology),
21 CFR 862.3620 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Drug Specific Calibrators,
Class II, DLJ (91 Toxicology),
21 CFR 862.3200 | |
| Common Name:
Proprietary Name: | Homogeneous Methadone Metabolite Enzyme Immunoassay
LZI Methadone Metabolite (EDDP) Enzyme Immunoassay,
LZI Methadone Metabolite (EDDP) (100 and 300) Calibrator | |
4
Legally Marketed Predicate Device(s)
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Methadone Metabolite (EDDP) Enzyme Immunoassay (K031797) manufactured by Lin-Zhi International, Inc. The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between EDDP in the sample and EDDP labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the EDDP concentration in the sample is measured in terms of enzyme activity. In the absence of EDDP in the sample, EDDP-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free EDDP is present in the sample, antibody would bind to free EDDP; the unbound EDDP-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains mouse monoclonal anti-methadone metabolite antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with methadone metabolite in buffer with sodium azide (0.09 %) as a preservative.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 250, 500 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0, 150, 225, 300, 375, 600, and 1000 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
5
Intended Use
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GCMS or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.
6
Comparison to Predicate Device
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Methadone Metabolite Enzyme Immunoassay, Calibrators and Controls cleared by the FDA under the premarket notification K031797 for its stated intended use.
The following table compares LZI's Methadone Metabolite (EDDP) Enzyme Immunoassay with the predicate device.
| Device
Characteristics | Subject Device (K170416)
LZI Methadone Metabolite (EDDP)
Enzyme Immunoassay and Methadone
Metabolite (EDDP) (100 and 300)
Calibrators | Predicate Device (K031797)
LZI Methadone Metabolite (EDDP)
Enzyme Immunoassay, Calibrators and
Controls |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Methadone Metabolite (EDDP)
Enzyme Immunoassay is an in vitro
diagnostic test intended for the qualitative
and semi-quantitative determination of
Methadone Metabolite in human urine.
The cutoff for the qualitative and semi-
quantitative modes of the assay are 100
ng/mL and 300 ng/mL for methadone
metabolite. The assay is designed for
prescription use on automated clinical
chemistry analyzers.
The assay provides only a preliminary analytical | The Lin-Zhi International, Inc. (LZI)
Methadone Metabolite (EDDP) Enzyme
Immunoassay is intended for the
qualitative and semi-quantitative
determination of methadone metabolite in
human urine at a cutoff value of 300
ng/mL. The assay is designed for
professional use with a number of
automated clinical chemistry analyzers.
This assay provides a rapid screening procedure
for determining the presence of methadone
metabolite in urine. The assay provides only a |
| | result. A more specific alternative analytical
chemistry method must be used in order to obtain a
confirmed analytical result. Gas or liquid
chromatography/mass spectrometry (GC/MS or
LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. | preliminary analytical result. A more specific
alternative chemical method must be used in order
to obtain a confirmed analytical result. Gas or
liquid chromatography/mass spectrometry (GC/MS
or LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. |
| Analyte | Methadone Metabolite (EDDP) | Methadone Metabolite (EDDP) |
| Cutoff | 100 and 300 ng/ml | 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrators
Level | 100 ng/mL Cutoff: 5 Levels
0, 50, 100, 250, and 500 ng/mL
300 ng/mL Cutoff: 5 Levels
0, 150, 300, 600, and 1000 ng/mL | 0, 150, 300, 600, and 1000 ng/mL |
| Storage | 2-8°C until expiration date | 2-8°C until expiration date |
7
Performance Characteristics Summary:
Beckman Coulter AU480 Analyzer
Precision: 100 ng/mL Cutoff
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| Methadone
Metabolite
(EDDP)
Concentration | Within Run
(N=22) | Total Precision
(N=88) |
|----------------------------------------------------|----------------------|---------------------------|
| 0 ng/mL | - | - |
| 25 ng/mL | - | - |
| 50 ng/mL | - | - |
| 75 ng/mL | - | - |
| 100 ng/mL | - | - |
| 125 ng/mL | + | + |
| 150 ng/mL | + | + |
| 175 ng/mL | + | + |
| 200 ng/mL | + | + |
Semi-Quantitative Positive/Negative Results:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Methadone | |||||
| Metabolite | |||||
| (EDDP) | |||||
| Concentration | % of Cutoff | # of Samples | EIA Result | # of Samples | EIA Result |
| 0 ng/mL | 0.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 25.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 50.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 75.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100.0 % | 22 | 11 Neg/11 Pos | 88 | 40 Pos/48 Neg |
| 125 ng/mL | 125.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | 150.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | 175.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | 200.0 % | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Positive/Negative Results:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Methadone | |||||
| Metabolite | |||||
| (EDDP) | |||||
| Concentration | % of Cutoff | # of Samples | EIA Result | # of Samples | EIA Result |
| 0 ng/mL | 0.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 25.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 50.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 75.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100.0 % | 22 | 13 Neg/ 9 Pos | 88 | 54 Neg/34 Pos |
| 125 ng/mL | 125.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | 150.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | 175.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | 200.0 % | 22 | 22 Positive | 88 | 88 Positive |
8
Performance Characteristics Summary, continued: Beckman Coulter AU480 Analyzer
Precision: 300 ng/mL Cutoff
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| Methadone
Metabolite
(EDDP)
Concentration | Within Run
(N=22) | Total Precision
(N=88) |
|----------------------------------------------------|----------------------|---------------------------|
| 0 ng/mL | - | - |
| 75 ng/mL | - | - |
| 150 ng/mL | - | - |
| 225 ng/mL | - | - |
| 300 ng/mL | + | + |
| 375 ng/mL | + | + |
| 450 ng/mL | + | + |
| 525 ng/mL | + | + |
| 600 ng/mL | + | + |
Semi-Quantitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Methadone | |||||
| Metabolite | |||||
| (EDDP) | |||||
| Concentration | % of Cutoff | # of Samples | EIA Result | # of Samples | EIA Result |
| 0 ng/mL | 0.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 25.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 50.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | 75.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0 % | 22 | 6 Neg/ 16 Pos | 88 | 36 Neg/ 52 Pos |
| 375 ng/mL | 125.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | 150.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | 175.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | 200.0 % | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Methadone | |||||
| Metabolite | |||||
| (EDDP) | % of Cutoff | # of Samples | EIA Result | # of Samples | EIA Result |
| Concentration | |||||
| 0 ng/mL | 0.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 25.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 50.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | 75.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0 % | 22 | 7 Neg/15 Pos | 88 | 33 Neg/55 Pos |
| 375 ng/mL | 125.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | 150.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | 175.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | 200.0 % | 22 | 22 Positive | 88 | 88 Positive |
9
Performance Characteristics Summary, continued: Beckman Coulter AU480 Analyzer
Method Comparison - Clinical Samples: 100 ng/mL Cutoff
From a total of eighty-seven (87) clinical unaltered samples, Semi-Quantitative & Qualitative Data:
| 100 ng/mL
Cutoff | Neg | 103.1 |
| Sample #46 | + | - | 126.0 |
10
Method Comparison - Clinical Samples: 300 ng/mL Cutoff
From a total of eighty-four (84) clinical unaltered samples, Semi-Quantitative & Qualitative Qualitative Accuracy Study:
| 300 ng/mL
Cutoff | Neg |