(29 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 in vitro diagnostic (IVD) immunoassay designed to detect tramadol in urine. It is used for analytical purposes to provide qualitative and semi-quantitative results, which require confirmation by other methods. It does not provide any direct therapeutic benefit or treatment to a patient.
Yes
The device is intended for the qualitative and semi-quantitative determination of tramadol in human urine, which provides preliminary analytical results for clinical consideration and professional judgment. This indicates its use in diagnosing or aiding in the diagnosis of tramadol presence.
No
The device is a reagent kit for an enzyme immunoassay, which is a chemical-based test requiring physical reagents and laboratory equipment (automated clinical chemistry analyzers) to function. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "intended for the qualitative and semi-quantitative determination of tramadol 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 the components and mechanism of an enzyme immunoassay, a common type of in vitro diagnostic test.
- Intended User / Care Setting: It specifies the device is for "laboratories with automated clinical chemistry analyzers" and is "for prescription use only". This indicates a clinical laboratory setting, typical for IVDs.
- Performance Studies: The document describes various performance studies (Precision, Analytical Recovery, Method Comparison, Cross-reactivity, Interference) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K182280) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for medical devices, including IVDs.
N/A
Intended Use / Indications for Use
The LZI Tramadol Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of tramadol in human urine at the cutoff value of 100 ng/mL when callbrated against tramadol. 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 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 alternative chemical method (e.g., gas or liquid chromatography 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 Tramadol Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-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 tramadol standard and referred to as tramadol-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, tramadol-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 tramadol-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Tramadol 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 Tramadol Enzyme Immunoassay is traceable to a commercially available tramadol standard.
The Ri solution contains mouse monoclonal anti-tramadol 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 tramadol 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories with 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
A total of eighty-six (86) unaltered clinical samples were tested with the LZI Tramadol Enzyme Immunoassay on the Beckman Coulter® AU480 automated clinical analyzer. Samples were evaluated against the OD of the cutoff calibrator in the qualitative mode and evaluated against the assay's calibration curve in the semi-quantitative mode. All samples were tested in singlet. All samples were confirmed with LC/MS for tramadol concentrations. Samples were collected by Lin-Zhi International, Inc. (LZI) and and the University of California at San Francisco (UCSF, San Francisco).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: 100 ng/mL Cutoff: The assay was tested in qualitative (ΔΟΣ, mAU) and semi-quantitative (ng/mL) mode using a modified NCCLS-EP5 protocol. Tramadol sample concentrations were prepared by spiking a tramadol standard into a pool of negative human urine at concentrations ±25 %, ±50 %, ±75 %, and ±100 % of the cutoff concentration. Results were obtained by testing all samples in replicate of two, two runs a day (one in the morning and one in the afternoon) for 22 days on one Beckman Coulter® AU480 automatic clinical analyzer for a total of 88 replicates.
Analytical Recovery: A drug free-urine pool spiked with tramadol at 400 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. Recovery ranged between 89 % - 116 %.
Method Comparison - Clinical Samples: 86 clinical samples were tested with the LZI Tramadol Enzyme Immunoassay on the Beckman Coulter® AU480 automated clinical analyzer. Samples were evaluated against the OD of the cutoff calibrator in the qualitative mode and against the assay's calibration curve in the semi-quantitative mode. All samples were tested in singlet and confirmed with LC/MS for tramadol concentrations. Agreement was 97.7 % for semi-quantitative results and 95.3% for qualitative results.
Cross-reactivity: Various potentially interfering drugs were tested by spiking various concentrations of each substance into a pool of negative human urine and then evaluated against the assay's calibration curve in both qualitative and semi-quantitative modes. All samples were tested in duplicates.
Endogenous and Preservative Compound Interference: Endogenous and Preservative compounds were spiked into pooled negative human urine to desired concentrations. These solutions were then split into three portions; one without tramaning two that were further spiked with tramadol standards to a final tramadol concentration of 75 ng/mL (as negative or positive controls, ±25 % of the cutoff concentration, respectively). Samples were evaluated against the assay's calibration curve in both qualitative modes. Interference was observed with Boric Acid at 1 % w/v. No other significant undesired cross-reactants or endogenous/preservative substance interference was observed.
Specific Gravity Interference: Samples ranging in specific gravity from 1.000 to 1.030 were split into three portions each and either spiked or further spiked to a final tramadol concentration of either 75 ng/mL (as negative or positive controls, ±25 % of the cutoff concentration, respectively). These samples were then evaluated in both semi-quantitative modes. No interference was observed.
pH Interference: Negative urine and urine spiked with tramadol to the final tramadol concentration of either 75 ng/mL or 125 ng/mL (as negative or positive controls, ±25 % of the cutoff concentration, respectively) were adjusted to the following pH levels and tested by the assay. The pH adjusted solutions were evaluated in both qualitative modes. No major interference was observed between pH 3 to pH 11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Semi-Quantitative Results:
% Agreement: 97.7 %
Qualitative Accuracy Study:
% Agreement: 95.3 %
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. The logos are placed side by side.
June 4, 2020
Lin-Zhi International, Inc. Bernice Lin VP Operations 2945 Oakmead Village Court Santa Clara, CA 95051
Re: K201223
Trade/Device Name: LZI Tramadol Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: Mav 4, 2020 Received: May 6, 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) K201223
Device Name
LZI Tramadol Enzyme Immunoassay
Indications for Use (Describe)
The LZI Tramadol Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of tramadol in human urine at the cutoff value of 100 ng/mL when callbrated against tramadol. 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 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 alternative chemical method (e.g., gas or liquid chromatography 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 Safetv 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
May 4, 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 (408) 970-9030 Fax: e-mail: bclin@lin-zhi.com
| Contact: | Bernice Lin, Ph.D. |
|---|---|
| VP Operations |
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Opiates Class II, DJG (91 Toxicology), 21 CFR 862.3650 |
|---|---|
| ---------------------- | ------------------------------------------------------------------------------ |
| Common Name: | Homogeneous Enzyme Immunoassay |
|---|---|
| Proprietary Name: | LZI Tramadol Enzyme Immunoassay |
4
Legally Marketed Predicate Device(s)
The LZI Tramadol Enzyme Immunoassay (EIA) is substantially equivalent to the ARKTM Tramadol Assay (K182280) manufactured by ARK Diagnostics, Inc. The LZI Tramadol 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 Tramadol Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-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 tramadol standard and referred to as tramadol-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, tramadol-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 tramadol-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 Tramadol 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 Tramadol Enzyme Immunoassay is traceable to a commercially available tramadol standard.
The Ri solution contains mouse monoclonal anti-tramadol 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 tramadol in buffer with sodium azide (0.09 %) as a preservative.
5
Intended Use
The LZI Tramadol Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of tramadol in human urine at the cutoff value of 100 ng/mL when calibrated against tramadol. 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 and 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.
6
Comparison to Predicate Device
The LZI Tramadol Enzyme Immunoassay is substantially equivalent to the ARK™ Tramadol Assay cleared by the FDA under the premarket notification K182280 for its stated intended use.
The following table compares LZI's Tramadol Enzyme Immunoassay with the predicate device.
| Device | Subject Device | Predicate Device (K182280) |
|---|---|---|
| Characteristics | LZI Tramadol Enzyme Immunoassay | ARK™ Tramadol Assay |
| Intended Use | Same | The ARK Tramadol Assay is an |
| immunoassay intended for the qualitative | ||
| and/or semiquantitative determination of | ||
| tramadol in human urine at a cutoff | ||
| concentration of 100 ng/mL. The assay is | ||
| intended for use in laboratories with | ||
| automated clinical chemistry analyzers. | ||
| This in vitro diagnostic device is for | ||
| prescription use only. | ||
| The semiquantitative mode is for the | ||
| purpose of (1) enabling laboratories to | ||
| determine an appropriate dilution of the | ||
| specimen for confirmation by a | ||
| confirmatory method, such as | ||
| Gas Chromatography/Mass Spectrometry | ||
| (GC/MS) or Liquid | ||
| Chromatography/tandem Mass | ||
| Spectrometry (LC-MS/MS), or (2) | ||
| permitting laboratories to establish quality | ||
| control procedures. | ||
| The ARK Tramadol Assay provides only | ||
| a preliminary analytical test result. A | ||
| more specific alternative chemical method | ||
| must be used in order to obtain a | ||
| confirmed positive 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 exercised with any drug test | ||
| result, particularly when the preliminary | ||
| test result is positive. | ||
| Analyte | tramadol | tramadol |
| Cutoff | 100 ng/ml | 100 ng/mL |
| Matrix | Urine | Urine |
| Calibrators Level | 0, 50, 100, 225, and 400 ng/mL | 0, 100, 200, 500, and 1000 ng/mL |
| Controls Level | 75 ng/mL and 125 ng/mL | 75 ng/mL and 125 ng/mL |
| Storage | 2-8 ℃ until expiration date | 2-8 ℃ until expiration date |
7
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 (ΔΟΣ, mAU) and semi-quantitative (ng/mL) mode using a modified NCCLS-EP5 protocol. Tramadol sample concentrations were prepared by spiking a tramadol standard into a pool of negative human 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, two runs a day (one in the morning and one in the afternoon) for 22 days on one Beckman Coulter® AU480 automatic clinical analyzer for a total of 88 replicates. Samples were evaluated against the OD of the cutoff calibrator in the qualitative mode and evaluated against the assay's calibration curve in the semi-quantitative mode. One single lot of reagents, calibrators, and controls were used and stored at 2-8℃ when not in use.
| Tramadol | Within Run (N=22) | Total Precision (N=88) | ||
|---|---|---|---|---|
| Concentration | Mean | Qualitative Response | Mean | Qualitative Response |
| 0 ng/mL | -1.0 | - | -1.0 | - |
| 25 ng/mL | 20.2 | - | 20.2 | - |
| 50 ng/mL | 49.8 | - | 49.8 | - |
| 75 ng/mL | 74.6 | - | 74.6 | - |
| 100 ng/mL | 101.5 | + | 101.5 | + |
| 125 ng/mL | 130.5 | + | 130.5 | + |
| 150 ng/mL | 162.7 | + | 162.7 | + |
| 175 ng/mL | 186.2 | + | 186.2 | + |
| 200 ng/mL | 210.2 | + | 210.2 | + |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
Semi-Quantitative Positive/Negative Results:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Tramadol | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| 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 | 16 Pos/6 Neg | 88 | 53 Pos/35 Neg |
| 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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| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Tramadol | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| 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 | 15 Pos/7 Neg | 88 | 48 Pos/40 Neg |
| 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 |
Qualitative Positive/Negative Results:
Analytical Recovery:
To demonstrate recovery of the entire assay range, a drug free-urine pool spiked with tramadol at 400 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.
Determined concentration averages were obtained and all averages were ±15 % of the target concentrations. The determined average percent recovery (Determined Concentration Average divided by the Target Concentration) were considered acceptable between 85 – 115 %.
The recovery of tramadol spiked to various concentrations was evaluated and was found to range between 89 % - 116 %.
| Target
Concentration
(ng/mL) | Determined
Concentration Range
(ng/mL) | Determined
Concentration Average
(ng/mL) | Average
% Recovery |
|------------------------------------|----------------------------------------------|------------------------------------------------|-----------------------|
| 400 | 395.2 – 433.3 | 412.7 | 103.2 % |
| 360 | 350.3 - 404.5 | 377.5 | 104.9 % |
| 320 | 316.5 - 371.6 | 346.9 | 108.4 % |
| 280 | 277.6 - 313.0 | 297.8 | 106.4 % |
| 240 | 221.7 – 279.7 | 245.1 | 102.1 % |
| 200 | 202.0 - 215.5 | 210.0 | 105.0 % |
| 160 | 168.2 – 180.2 | 174.5 | 109.1 % |
| 120 | 122.8 – 134.2 | 130.1 | 108.4 % |
| 80 | 78.0 – 84.6 | 80.9 | 101.1 % |
| 40 | 35.6 - 43.0 | 39.3 | 98.2 % |
| 0 | -4.6 - 1.3 | -2.2 | N/A |
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Method Comparison - Clinical Samples:
A total of eighty-six (86) unaltered clinical samples were tested with the LZI Tramadol Enzyme Immunoassay on the Beckman Coulter® AU480 automated clinical analyzer. Samples were evaluated against the OD of the cutoff calibrator in the qualitative mode and evaluated against the assay's calibration curve in the semi-quantitative mode. All samples were tested in singlet.
All samples were confirmed with LC/MS for tramadol concentrations. Samples were collected by Lin-Zhi International, Inc. (LZI) and and the University of California at San Francisco (UCSF, San Francisco).
| Tramadol
Results
100
ng/mL
Cutoff | Negative |