(58 days)
Not Found
No
The device description and performance studies detail 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 immunoassay designed to detect oxycodone in human urine, providing diagnostic information rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states: "The LZI Oxycodone III Enzyme Immunoassay is intended for the quantitative determination of oxycodone in human urine... The assay provides only a preliminary analytical result." This indicates that the device is used to perform an assay to generate analytical results for determining a substance in human urine, which falls under the definition of a diagnostic device.
No
The device is a chemical assay kit comprised of liquid reagents, which are physical components, not software. While it is used with automated clinical chemistry analyzers (which likely involve software), the device itself is the reagent kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of oxycodone in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details a "homogeneous enzyme immunoassay with ready-to-use liquid reagents" and a "kit comprised of two reagents." These are components of an in vitro diagnostic test kit.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Performance Studies: The document describes various performance studies (Precision, Analytical Recovery, Method Comparison, Cross-reactivity, etc.) conducted to validate the assay's performance for its intended diagnostic purpose.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K120763; LZI Oxycodone Assay) strongly indicates that this device is being compared to a previously cleared IVD.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Oxycodone III Enzyme Immunoassay is intended for the quantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of 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 GC/MS or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatograpy and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes
DJG
Device Description
The LZI Oxycodone III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available oxycodone standard and referred to as oxycodone-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, oxycodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound oxycodone-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 Oxycodone III Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2, which are bottled separately but sold together within the kit. The LZI Oxycodone III Enzyme Immunoassay is traceable to a commercially available oxycodone standard.
The Ri solution contains mouse monoclonal anti-oxycodone antibody, glucose-6-phosphate (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 oxycodone in buffer with sodium azide (0.09 %) as a preservative.
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
Not Found
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
A total of eighty-two (82) unaltered clinical samples were tested with the LZI Oxycodone III Enzyme Immunoassay on the Beckman Coulter AU480 automated clinical analyzer. All samples were tested in singlet.
For the 300 ng/mL cutoff, a total of ninety (90) unaltered clinical samples were tested with the LZI Oxycodone III Enzyme Immunoassay on the Beckman Coulter AU480 automated clinical analyzer. All samples were tested in singlet. All samples were confirmed with LC/MS for oxycodone and oxymorphone concentrations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Precision: 100 ng/mL Cutoff
- Sample Size: Samples tested in replicate of two runs a day for 22 days on one Beckman Coulter AU480 automatic clinical analyzer for a total of 88 runs. Oxycodone concentrations tested at 0, 25, 50, 75, 100, 125, 150, 175, 200 ng/mL for semi-quantitative and qualitative modes.
- Key Results:
- Semi-Quantitative Positive/Negative Results for 100 ng/mL Cutoff:
- At 100 ng/mL, 5 Negative / 17 Positive for Within Run (N=22) and 26 Negative / 62 Positive for Total Precision (N=88).
- Qualitative Positive/Negative Results for 100 ng/mL Cutoff:
- At 100 ng/mL, 9 Negative / 13 Positive for Within Run (N=22) and 33 Negative / 55 Positive for Total Precision (N=88).
- Semi-Quantitative Positive/Negative Results for 100 ng/mL Cutoff:
- Study Type: Analytical Recovery: 100 ng/mL Cutoff
- Sample Size: Drug-free urine pool spiked with oxycodone at 300 ng/mL was serially diluted. Each sample was run in 10 replicates.
- Key Results: Determined Concentration Average and Average % Recovery for various target concentrations from 0 to 300 ng/mL. All average % recoveries were between 90.3% and 110.0%.
- Study Type: Method Comparison - Clinical Samples: 100 ng/mL Cutoff
- Sample Size: 82 unaltered clinical samples.
- Key Results:
- Semi-Quantitative Results: Overall agreement of 90.2% for Positive results and 95.1% for Negative results.
- Qualitative Accuracy Study: Overall agreement of 90.2% for Positive results and 95.1% for Negative results.
- Study Type: Cross-reactivity: 100 ng/mL Cutoff
- Sample Size: Not specified, but various concentrations of potentially interfering drugs were spiked into pooled negative human urine. All samples were tested in duplicates.
- Key Results:
- Oxycodone and Major Metabolites: Oxycodone and Oxymorphone showed 100.00% cross-reactivity. Noroxycodone and Noroxymorphone showed very low cross-reactivity (0.40% and 0.17%).
- Structurally Related Compounds: Hydrocodone and Hydromorphone showed 0.40% cross-reactivity. Oxymorphone-3beta-D-Glucuronide showed 43.48% cross-reactivity. Many others showed Not Detected (ND).
- Structurally Unrelated Pharmacological Compounds: No interference observed at -25% and +25% oxycodone cutoff concentrations.
- Study Type: Endogenous and Preservative Compound Interference: 100 ng/mL Cutoff
- Sample Size: Various concentrations of compounds spiked into pooled negative human urine. All samples were tested in duplicates.
- Key Results: Boric Acid at 1000 mg/dL showed negative results at both -25% and +25% oxycodone cutoff. All other substances showed expected results (Neg at -25% and Pos at +25%).
- Study Type: Specific Gravity Interference: 100 ng/mL Cutoff
- Sample Size: Samples ranging in specific gravity from 1.000 to 1.030.
- Key Results: No deviations from expected positive or negative results.
- Study Type: pH Interference: 100 ng/mL Cutoff
- Sample Size: Urine adjusted to pH levels from 3 to 11.
- Key Results: No deviations from expected results.
- Study Type: Precision: 300 ng/mL Cutoff
- Sample Size: Samples tested in replicate of two runs a day for 22 days on one Beckman Coulter AU480 automatic clinical analyzer for a total of 88 runs. Oxycodone concentrations tested at 0, 75, 150, 225, 300, 375, 450, 525, 600 ng/mL for semi-quantitative and qualitative modes.
- Key Results:
- Semi-Quantitative Positive/Negative Results for 300 ng/mL Cutoff:
- At 300 ng/mL, 6 Neg / 16 Pos for Within Run (N=22) and 27 Neg / 61 Pos for Total Precision (N=88).
- Qualitative Positive/Negative Results for 300 ng/mL Cutoff:
- At 300 ng/mL, 10 Neg / 12 Pos for Within Run (N=22) and 40 Neg / 48 Pos for Total Precision (N=88).
- Semi-Quantitative Positive/Negative Results for 300 ng/mL Cutoff:
- Study Type: Analytical Recovery: 300 ng/mL Cutoff
- Sample Size: Drug-free urine pool spiked with oxycodone at 800 ng/mL was serially diluted. Each sample was run in 10 replicates.
- Key Results: Determined Concentration Average and Average % Recovery for various target concentrations from 0 to 800 ng/mL. All average % recoveries were between 104.5% and 111.5%.
- Study Type: Method Comparison - Clinical Samples: 300 ng/mL Cutoff
- Sample Size: 90 unaltered clinical samples.
- Key Results:
- Semi-Quantitative Results: Overall agreement of 97.8% for Positive results and 95.6% for Negative results.
- Qualitative Accuracy Study: Overall agreement of 95.6% for Positive results and 95.6% for Negative results.
- Study Type: Cross-reactivity: 300 ng/mL Cutoff
- Sample Size: Not specified, but various concentrations of potentially interfering drugs were spiked into pooled negative human urine. All samples were tested in duplicates.
- Key Results:
- Oxycodone and Major Metabolites: Oxycodone and Oxymorphone showed 100.00% cross-reactivity. Noroxycodone showed 0.40% cross-reactivity, Noroxymorphone was Not Detected.
- Structurally Related Compounds: Hydrocodone and Hydromorphone showed 0.40% cross-reactivity. Oxymorphone-3beta-D-Glucuronide showed 42.86% cross-reactivity. Many others were Not Detected (ND).
- Structurally Unrelated Pharmacological Compounds: No interference observed at -25% and +25% oxycodone cutoff concentrations.
- Study Type: Endogenous and Preservative Compound Interference: 300 ng/mL Cutoff
- Sample Size: Various concentrations of compounds spiked into pooled negative human urine. All samples were tested in duplicates.
- Key Results: Boric Acid at 1000 mg/dL showed negative results for the -25% cutoff and positive for the +50% cutoff indicating some interference at the 300 ng/mL cutoff. All other substances showed expected results.
- Study Type: Specific Gravity Interference: 300 ng/mL Cutoff
- Sample Size: Samples ranging in specific gravity from 1.000 to 1.030.
- Key Results: No deviations from expected positive or negative results.
- Study Type: pH Interference: 300 ng/mL Cutoff
- Sample Size: Urine adjusted to pH levels from 3 to 11.
- Key Results: No deviations from expected results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance metrics are described as "Agreement" for method comparison and qualitative accuracy studies)
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
September 17, 2020
Lin-Zhi International, Inc. Bernice Lin VP of Operations 2945 Oakmead Village Court Santa Clara, CA 95051
Re: K202007
Trade/Device Name: LZI Oxycodone III Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: July 17, 2020 Received: July 21, 2020
Dear Bernice 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202007
Device Name
LZI Oxycodone III Enzyme Immunoassay
Indications for Use (Describe)
The LZI Oxycodone III Enzyme Immunoassay is intended for the quantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of 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 GC/MS or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatograpy and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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.
510(k) Number
Prepared On
September 14, 2020
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 Fax: (408) 970-9030 e-mail: bclin@lin-zhi.com
| Contact: | Bernice Lin, Ph.D. |
|---|---|
| VP of Operations |
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Oxycodone
Class II, DJG (91 Toxicology)
21 CFR 862.3650 |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Oxycodone Enzyme Immunoassay |
| Proprietary Name: | LZI Oxycodone III Enzyme Immunoassay |
4
Legally Marketed Predicate Device(s)
The LZI Oxycodone III Enzyme Immunoassay (EIA) is substantially equivalent to the LZI Oxycodone Assay (K120763) manufactured by Lin-Zhi International, Inc. (LZI). The LZI Oxycodone III 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 Oxycodone III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available oxycodone standard and referred to as oxycodone-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, oxycodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound oxycodone-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 Oxycodone III Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2, which are bottled separately but sold together within the kit. The LZI Oxycodone III Enzyme Immunoassay is traceable to a commercially available oxycodone standard.
The Ri solution contains mouse monoclonal anti-oxycodone antibody, glucose-6-phosphate (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 oxycodone in buffer with sodium azide (0.09 %) as a preservative.
Intended Use
The LZI Oxycodone III Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL and 300 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of 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 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 alternative chemical method (e.g., gas or liquid chromatograpy and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
5
Comparison to Predicate Device
The LZI Oxycodone III Enzyme Immunoassay is substantially equivalent to the LZI Oxycodone Assay cleared by the FDA under the premarket notification K120763 for its stated intended use.
| Device
| Characteristics | Subject Device | Predicate Device (K120763) |
|---|---|---|
| Intended Use | LZI Oxycodone III Enzyme Immunoassay | |
| The Lin-Zhi International, Inc. (LZI) | ||
| Oxycodone III Enzyme Immunoassay is | ||
| intended for the qualitative and semi- | ||
| quantitative determination of oxycodone in | ||
| human urine at a cutoff value of 100 | ||
| ng/mL and 300 ng/mL when calibrated | ||
| against oxycodone. The assay is designed | ||
| for prescription use with a number of | ||
| automated clinical chemistry analyzers. | ||
| The semi-quantitative mode is for | ||
| purposes of (1) enabling laboratories to | ||
| determine an appropriate dilution of the | ||
| specimen for verification by a | ||
| confirmatory method such as 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 | ||
| alternative chemical confirmatory | ||
| method (e.g., gas or liquid | ||
| chromatography and mass | ||
| spectrometry) must be used to obtain a | ||
| confirmed analytical result (1, 2). | ||
| Clinical consideration and professional | ||
| judgment should be exercised with any | ||
| drug of abuse test result, particularly | ||
| when the preliminary test result is | ||
| positive. | LZI Oxycodone Enzyme Immunoassay | |
| The Lin-Zhi International, Inc. (LZI) | ||
| Oxycodone Enzyme Immunoassay is | ||
| intended for the qualitative and semi- | ||
| quantitative determination of oxycodone | ||
| in human urine, at cutoff values of 100 | ||
| ng/mL and 300 ng/mL. The assay is | ||
| designed for prescription use with a | ||
| number of automated clinical chemistry | ||
| analyzers. | ||
| 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) are | ||
| the preferred confirmatory methods. | ||
| Clinical consideration and professional | ||
| judgment should be exercised with any | ||
| drug of abuse test result, particularly | ||
| when the preliminary test result is | ||
| positive. | ||
| Target Analyte | oxycodone | oxycodone |
| Cutoff | 100 ng/ and 300 ng/mL | 100 and 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrator Levels | 100 ng/mL Cutoff: 5 Levels | |
| 0, 50, 100, 150, and 300 ng/mL |
300 ng/mL Cutoff: 5 Levels
0, 150, 300, 500, and 800 ng/mL | 0, 50, 100, 300, 500, and
800 ng/mL |
The following table compares LZI Oxycodone III Enzyme Immunoassay with the predicate device.
6
| Device
| Characteristics | Subject Device | Predicate Device (K120763) |
|---|---|---|
| Control Levels | LZI Oxycodone III Enzyme Immunoassay | LZI Oxycodone Enzyme Immunoassay |
| 100 ng/mL Cutoff: 2 Levels | ||
| 75 and 125 ng/mL | 100 ng/mL Cutoff: 2 Levels | |
| 75 and 125 ng/mL | ||
| 300 ng/mL Cutoff: 2 Levels | ||
| 225 and 375 ng/mL | 300 ng/mL Cutoff: 2 Levels | |
| 225 and 375 ng/mL | ||
| Storage | 2-8 °C until expiration date |
Performance Characteristics Summary:
All validation studies below were conducted on the Beckman Coulter® AU480 Analyzer
Precision: 100 ng/mL Cutoff
The assay was tested in qualitative and semi-quantitative mode by spiking oxycodone into pooled negative urine at concentrations ±25 %, ±50 %, ±75 %, and ±100 % of the cutoff concentration.
Results shown below were obtained by testing all samples in replicate of two runs a day for 22 days on one Beckman Coulter AU480 automatic clinical analyzer for a total of 88 runs.
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Oxycodone | % of Cutoff | Number of | Immunoassay | Number of | Immunoassay |
| Concentration | Determinations | Result | Determinations | Result | |
| 0 ng/mL | 0 % | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 25 % | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 50 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 75 % | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100 % | 22 | 5 Neg / 17 Pos | 88 | 26 Neg / 62 Pos |
| 125 ng/mL | 125 % | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | 150 % | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | 175 % | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | 200 % | 22 | 22 Positive | 88 | 88 Positive |
Semi-Quantitative Positive/Negative Results:
Qualitative Positive/Negative Results:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Oxycodone | % of Cutoff | Number of | Immunoassay | Number of | Immunoassay |
| Concentration | Determinations | Result | Determinations | Result | |
| 0 ng/mL | 0 % | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 25 % | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 50 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 75 % | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100 % | 22 | 9 Neg / 13 Pos | 88 | 33 Neg / 55 Pos |
| 125 ng/mL | 125 % | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | 150 % | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | 175 % | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | 200 % | 22 | 22 Positive | 88 | 88 Positive |
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Analytical Recovery: 100 ng/mL Cutoff
To demonstrate recovery of the entire assay range, a drug free-urine pool spiked with oxycodone at 300 ng/mL was serially diluted. Each sample was run in 10 replicates and the average was used to determine percent recovery compared to the expected target value. Results are summarized below:
| Target
Concentration
(ng/mL) | Determined
Concentration Range
(ng/mL) | Determined
Concentration Average
(ng/mL) | Average
% Recovery |
|------------------------------------|----------------------------------------------|------------------------------------------------|-----------------------|
| 300 | 299.7 - 304.7 | 302.1 | 100.7 % |
| 270 | 277.5 - 287.4 | 282.7 | 104.7 % |
| 240 | 253.3 - 264.3 | 260.4 | 108.5 % |
| 210 | 219.8 - 241.2 | 231.0 | 110.0 % |
| 180 | 193.3 - 201.8 | 197.0 | 109.5 % |
| 150 | 149.1 - 158.7 | 153.6 | 102.4 % |
| 120 | 118.6 - 124.2 | 121.4 | 101.2 % |
| 90 | 86.3 - 90.7 | 88.8 | 98.6 % |
| 60 | 54.5 - 59.4 | 56.9 | 94.8 % |
| 30 | 25.7 - 29.5 | 27.1 | 90.3 % |
| 0 | -0.7 - 1.7 | 0.7 | N/A |
Method Comparison - Clinical Samples: 100 ng/mL Cutoff
A total of eighty-two (82) unaltered clinical samples were tested with the LZI Oxycodone III Enzyme Immunoassay on the Beckman Coulter AU480 automated clinical analyzer. All samples were tested in singlet.
Semi-Quantitative Results:
| Oxycodone
Results
100 ng/mL
Cutoff | Negative | 50** | 12.6 | 118.5 | 131.1 |
| 52** | 36.9 | 101.8 | 138.7 |
- Discordant between 50 % below cutoff and cutoff concentration (50 - 99.9 ng/mL)
** Discordant between cutoff and 50 % above cutoff concentration (100 - 149.9 ng/mL)
Qualitative Accuracy Study:
| Oxycodone
Results
100 ng/mL
Cutoff | Negative | l -Thyroxine | 10,000 | Neg | Pos |
| Tramadol | 100,000 | Neg | Pos |
| Zolpidem | 10,000 | Neg | Pos |
Structurally Unrelated Pharmacological Compounds: 100 ng/mL Cutoff
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Endogenous and Preservative Compound Interference: 100 ng/mL Cutoff
Endogenous and Preservative compounds were spiked into pooled negative human urine to desired concentrations. These solutions were then split into three portions; one without oxycodone, and the remaining two that were further spiked with oxycodone standards to a final oxycodone concentration of 75 ng/mL or 125 ng/mL (as negative or positive controls, ±25 % of the cutoff concentration, respectively). Samples were then evaluated against the cutoff calibrator in qualitative mode and the assay's calibration curve in semi-quantitative mode. All samples were tested in duplicates.
| Interfering Substance | Concentration
of Compound
(mg/dL) | -25 % Oxycodone Cutoff
(75 ng/mL) | +25 % Oxycodone Cutoff
(125 ng/mL) |
|--------------------------|-----------------------------------------|--------------------------------------|---------------------------------------|
| Acetone | 1000 | Neg | Pos |
| Ascorbic Acid | 1500 | Neg | Pos |
| Bilirubin | 2 | Neg | Pos |
| Boric Acid | 1000 | Neg | Neg |
| Calcium Chloride (CaCl2) | 300 | Neg | Pos |
| Citric Acid (pH 3) | 800 | Neg | Pos |
| Creatinine | 500 | Neg | Pos |
| Ethanol | 1000 | Neg | Pos |
| Galactose | 10 | Neg | Pos |
| y-Globulin | 500 | Neg | Pos |
| Glucose | 3000 | Neg | Pos |
| Hemoglobin | 300 | Neg | Pos |
| β-hydroxybutyric Acid | 100 | Neg | Pos |
| Human Serum Albumin | 500 | Neg | Pos |
| Oxalic Acid | 100 | Neg | Pos |
| Potassium Chloride | 6000 | Neg | Pos |
| Riboflavin | 7.5 | Neg | Pos |
| Urea | 6000 | Neg | Pos |
| Uric Acid | 10 | Neg | Pos |
| Sodium Azide | 1000 | Neg | Pos |
| Sodium Chloride | 6000 | Neg | Pos |
| Sodium Fluoride | 1000 | Neg | Pos |
| Sodium Phosphate | 300 | Neg | Pos |
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The following endogenous and preservative compounds which showed interference at ±25 % of the cutoff concentration were then spiked into negative urine and at ±50 % of the cutoff concentration (50 ng/mL and 150 ng/mL) for the assay.
Interference was observed with Boric Acid at 1 % w/v. No other significant undesired crossreactants or endogenous/preservative substance interference were observed.
| Interfering Substance | Concentration
of Compound
(mg/dL) | -50 % Oxycodone Cutoff
(50 ng/mL) | +50 % Oxycodone Cutoff
(150 ng/mL) |
|-----------------------|-----------------------------------------|--------------------------------------|---------------------------------------|
| Boric Acid | 1000 | Neg | Neg |
Specific Gravity Interference: 100 ng/mL Cutoff
Samples ranging in specific gravity from 1.000 to 1.030 were spiked to a final oxycodone concentration of either 75 ng/mL or 125 ng/mL (as negative or positive controls, ±25 % of the cutoff concentration. respectively). These samples were then evaluated in both semi-quantitative and qualitative modes. There were no deviations from the expected positive or negative results.
pH Interference: 100 ng/mL Cutoff
Negative urine and urine spiked with oxycodone to a final oxycodone concentration of either 75 ng/mL or 125 ng/mL (as negative or positive controls. ±25 % of the cutoff concentration. respectively) were adjusted to pH levels from 3 to 11 and tested by the assay. The pH adjusted solutions were evaluated in both qualitative and semi-quantitative modes and there were no deviations from the expected results.
Precision: 300 ng/mL Cutoff
The assay was tested in qualitative and semi-quantitative mode by spiking oxycodone into pooled negative urine at concentrations ±25 %, ±50 %, ±75 %, and ±100 % of the cutoff concentration.
Results shown below were obtained by testing all samples in replicate of two runs a day for 22 days on one Beckman Coulter AU480 automatic clinical analyzer for a total of 88 runs.
| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Oxycodone | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | 0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 25 % | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 50 % | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | 75 % | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100 % | 22 | 6 Neg/16 Pos | 88 | 27 Neg/61 Pos |
| 375 ng/mL | 125 % | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | 150 % | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | 175 % | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | 200 % | 22 | 22 Positive | 88 | 88 Positive |
Semi-Ouantitative Positive/Negative Results:
Qualitative Positive/Negative Results:
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| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Oxycodone | |||||
| Concentration | % of Cutoff | Number of | |||
| Determinations | Immunoassay | ||||
| Result | Number of | ||||
| Determinations | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | 0 % | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | 25 % | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 50 % | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | 75 % | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100 % | 22 | 10 Neg / 12 Pos | 88 | 40 Neg / 48 Pos |
| 375 ng/mL | 125 % | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | 150 % | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | 175 % | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | 200 % | 22 | 22 Positive | 88 | 88 Positive |
Analytical Recovery: 300 ng/mL Cutoff
To demonstrate recovery of the entire assay range, a drug free-urine pool spiked with oxycodone at 800 ng/mL was serially diluted. Each sample was run in 10 replicates and the average was used to determine percent recovery compared to the expected target value. Results are summarized below.
| Target
Concentration
(ng/mL) | Determined
Concentration Range
(ng/mL) | Determined
Concentration Average
(ng/mL) | Average
% Recovery |
|------------------------------------|----------------------------------------------|------------------------------------------------|-----------------------|
| 800 | 829.6 - 859.3 | 843.5 | 105.4 % |
| 720 | 769.7 - 794.1 | 784.2 | 108.9 % |
| 640 | 689.6 - 731.2 | 712.8 | 111.4 % |
| 560 | 603.8 - 640.0 | 624.3 | 111.5 % |
| 480 | 497.8 - 525.2 | 514.2 | 107.1 % |
| 400 | 427.2 - 451.5 | 436.8 | 109.2 % |
| 320 | 327.6 - 359.1 | 345.0 | 107.8 % |
| 240 | 242.9 - 260.8 | 250.8 | 104.5 % |
| 160 | 168.3 - 183.4 | 173.9 | 108.7 % |
| 80 | 82.9 - 95.0 | 89.0 | 111.2 % |
| 0 | -5.2 - 5.9 | 0.3 | N/A |
Method Comparison - Clinical Samples: 300 ng/mL Cutoff
A total of ninety (90) unaltered clinical samples were tested with the LZI Oxycodone III Enzyme Immunoassay on the Beckman Coulter AU480 automated clinical analyzer. All samples were tested in singlet.
All samples were confirmed with LC/MS for oxycodone and oxymorphone concentrations.
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Semi-Quantitative Results:
| Oxycodone
Results
300 ng/mL
Cutoff | Negative |