(88 days)
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No
The device description and performance studies focus on immunochromatographic principles and do not mention any computational analysis or algorithms, let alone AI/ML.
No.
This device is for the rapid, qualitative detection of oxycodone in human urine for diagnostic purposes, not for treating any condition.
Yes
This device is designed for the rapid, qualitative detection of oxycodone in human urine, providing a preliminary analytical test result that can assist in determining the presence of the drug.
No
The device description clearly indicates it is a physical immunochromatographic test strip with antibody colloidal gold, a drug conjugate, and a control line. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "rapid, qualitative detection of oxycodone in human urine." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of oxycodone).
- Device Description: The description details the components and mechanism of the test strip, which involves chemical reactions with the urine sample to produce a result. This is consistent with the nature of an IVD.
- Performance Studies: The document describes performance studies that involve testing clinical urine samples and comparing results to a reference method (GC/MS). This type of validation is standard for IVDs to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (K040411; DRI Oxycodone Assay, 100 ng/mL Cutoff) which is also an IVD, further supports the classification of this device as an IVD.
Therefore, based on the provided information, the MEDTOX® OXYCODONE Test System clearly fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale.
The test detects oxycodone at concentrations 100 ng/mL and above.
THE MEDTOX® OXYCODONE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold, When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical performance: a. Precision/Reproducibility:
Performance around the cutoff concentration was evaluated by testing drugfree urines spiked with standard solutions. Drug free urine was also tested. Testing was performed in triplicate on 6 different occasions by 3 MEDTOX employees who did not develop the test. Samples were randomized and presented as a blind panel.
The test consistently gave negative results (100%) for natural urine spiked to 75% below the cutoff (25 ng/mL). and negative results the majority of the time (93%) for 50% below the cutoff (50 ng/mL). The test consistently gave positive results for natural urine spiked above the cut-off (98% 125 ng/mL and 100% for 150 ng/mL), and positive results the majority of the time (93%) at the cutoff.
POC Studies:
Precision studies were performed by 9 POC operators at 3 different sites using randomized blind samples. Each operator tested 5 replicates of the 6 levels below. Results at 75% below the cutoff and 50% above the cutoff were consistent and identical to the results with MEDTOX employees. Results at the other levels were similar to the professional study.
b. Linearity/assay reportable range: Not applicable. The assay is intended for qualitative use.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): No calibrators are required. The device is calibrated during the manufacturing process. Controls are required but are not specified in the labeling. Users are instructed to follow federal. state and local guidelines concerning QC practices. Traceability is not covered in the submission.
d. Detection Limit: This information appears in the precision section above.
e. Analytical specificity: Cross-Reactivity: The following metabolites and compounds were initially dissolved in appropriate solvents and then added at varying concentrations to drug-free urine for evaluation. Samples were evaluated in triplicate by in-house operators. Results are expressed as the minimum concentration of metabolite or compound required to produce a positive test result. Percent cross reactivity of a compound is calculated by dividing the cutoff concentration by the minimum concentration required to obtain a positive result and then multiplying by 100%.
Oxycodone: Positive at 100 ng/mL (100% cross-reactivity)
Oxymorphone: Positive at 200 ng/mL (50% cross-reactivity)
Other compounds tested with varying cross-reactivity or negative results.
Non Cross-reactive Endogenous Compounds: Tested compounds gave negative results.
Interference: pH and Specific Gravity: The test was assayed with six negative clinical samples with pH values ranging from 4.0 to 9.0 ± 0.1. All pH levels gave negative results when fortified to 25 ng/mL, and positive results when fortified to 150 ng/mL. The test was assayed with eight samples with specific gravity values ranging from 1.003 to 1.035 ± 0.001. All specific gravity levels gave negative results when fortified to 25 ng/mL, and positive results when fortified to 150 ng/mL.
Common Drugs: None of the common drugs listed affected the expected results.
f. Assay cutoff: The assay cutoff is 100 ng/mL, the same as the predicate device.
2. Comparison studies: a. Method comparison studies: A method comparison study was performed at three Point of Care sites. Performance was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of oxycodone. Results were then compared to GC/MS results.
% Agreement among positives is 96%
% Agreement among negatives is 97%
b. Matrix comparison: Not applicable. The assay is intended for human urine samples only.
3. Clinical studies: Not applicable. Clinical studies are not typically submitted for this device type and matrix.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement among positives is 96%
Agreement among negatives is 97%
Ability to detect true negative samples: 100%
Ability to detect true positive samples (+50% above cut-off): 98%
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.
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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).
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§ 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/1 description: The image shows the logo for MEDTOX Diagnostics, Inc. The logo is in black and features the word "MEDTOX" in large, bold letters, with a registered trademark symbol to the right of the "X". Below "MEDTOX" is the phrase "DIAGNOSTICS, INC." in smaller, sans-serif font.
510(k) Summary
| Purpose for Submission: | Traditional 510(k) for New Assay |
|---|---|
| Analyte: | Oxycodone |
| Applicant: | MedTox Diagnostics, Inc. |
| 1238 Anthony Road | |
| Burlington, NC 27215 | |
| Telephone: 1-800-334-1116 | |
| FAX: 1-336-229-4471 | |
| Establishment Number: 1050155 | |
| MAY 12 2006 | |
| Contact Person: | Phillip Hartzog |
| Associate Director, Research and Development | |
| Telephone: 1-336-226-6311 ext 230 | |
| Cell Phone: 336-953-6576 | |
| E-mail: phartzog@medtox.com | |
| Date Prepared: | February 10, 2006 |
| Device Trade Name: | MEDTOX® OXYCODONE |
| Regulatory Information: | 862.3650 Enzyme Immunoassay, Opiates |
| Classification: | Class II |
| Product Code: | DJG |
| Panel: | 91 (Toxicology) |
| Predicate Device: | DRI Oxycodone Assay, 100 ng/mL Cutoff |
| 510(k) Number: K040411 |
Indications for Use
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or
1
forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale.
Workplace operators that may use this device are defined as individuals with a minimum of a high school education who also satisfy the following training and certification guidelines:
(1)Training should be conducted by a qualified professional and include a demonstration of the MEDTOX® OXYCODONE test system and (2) the use of quality assurance samples for monitoring and confirming the performance of the test system. Trainers should observe and confirm that the operator (3) uses proper technique when running a test sample and quality assurance samples. (4) has a basic understanding of test results, including the potential for false positive and false negative results, (5) knows how to prepare a sample for shipment to the laboratory for confirmation testing, (6) has reviewed the information contained in the MEDTOX® Training and Certification Program (available at www.medtox.com) and (7) that the operator minimally achieves a score of 80% on the written exam provided by MEDTOX®.
Operators achieving a score of 80% will be provided with a certificate of training participation. Quality assurance samples appropriate for training are available from MEDTOX® Diagnostics, Inc. Additionally, MEDTOX® Technical Support will provide access to assistance from individuals who are experienced in the interpretation of drug testing results.
The test detects oxycodone at concentrations 100 ng/mL and above.
THE MEDTOX® OXYCODONE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT.
Test Principle
Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold,
When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.
2
Interpretation of Results
Negative: When no drug is present in the urine sample, the red antibody-colloidal gold migrates up the test strip and binds to the drug conjugate immobilized on the membrane. The binding of the antibody-colloidal gold to the drug conjugate generates a line at the test line position on the device.
Positive: When drug is present in the sample the antibody-colloidal gold binds the drug before it migrates up the test strip. However, when the antibody-colloidal gold binds the drug in the urine, the antibody-colloidal gold can not bind to the drug coniugate immobilized on the test strip. When the drug concentration is at or above the cutoff concentration, the majority of the antibody-colloidal gold is bound to the drug in the urine. Therefore, as the drug bound antibody-colloidal gold migrates up the test strip it is unable to bind to the drug conjugate immobilized on the membrane. Therefore no line is generated at the test line position on the device.
Control Line: The test strip has an internal procedural control. A control line forms when the antibody-colloidal gold binds to the anti-mouse immunoglobulin antibody immobilized on the membrane at the control line position on the device. A line must form at the control line position on the device to indicate that there was an adequate volume of sample, the reagents migrated properly, and that the test strip is intact.
Summary of MEDTOX® OXYCODONE Performance Testing
1. Analytical performance:
a. Precision/Reproducibility:
Performance around the cutoff concentration was evaluated by testing drugfree urines spiked with standard solutions. Drug free urine was also tested. Testing was performed in triplicate on 6 different occasions by 3 MEDTOX employees who did not develop the test. Samples were randomized and presented as a blind panel.
Data from this study is presented below. The test consistently gave negative results (100%) for natural urine spiked to 75% below the cutoff (25 ng/mL). and negative results the majority of the time (93%) for 50% below the cutoff (50 ng/mL). The test consistently gave positive results for natural urine spiked above the cut-off (98% 125 ng/mL and 100% for 150 ng/mL), and positive results the majority of the time (93%) at the cutoff. Most of the variability in test results occurred at 25% below the cutoff (75 ng/mL), and here the results were as variable between replicates of the sample as between operators.
| A Property and Property of Children
A C
Oxycodone Cutoff = 100 ng/mL
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
|---|---|---|---|
| Conc. | |||
| na/m | Number Tested | ||
| 1 | |||
| Positive | ------ | ||
| BURICAL | |||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A C - Children Charles on A B A B A B A B A B A B A B - A B - A B - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A | ||
| A COLLECT OF CONSULERS | 40-44-4-4 | ||
| ------------------------------------- | |||
| CORPORACIAL |
|
A LAND BLO | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
3
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
|---|---|---|---|
| . | |||
| Autober 4000 | ి విశ | ||
| --------------------------------------- | |||
| 1 | |||
| 400 | *** | ||
| Acres Annual A |
- Children
: | A PROPERTY | |
| 446
CALL CON
A MINE AN
1 AP
t | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ﻟﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ | 1 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
t | .
| -4-4-400-40
| .
1 |
POC Studies:
Precision studies were performed by 9 POC operators at 3 different sites using randomized blind samples. Each operator tested 5 replicates of the 6 levels below. The results obtained from each of the 3 sites (Site1, Site2, Site3) are listed below. Results at 75% below the cutoff and 50% above the cutoff were consistent and identical to the results with MEDTOX employees. Results at the other levels were similar to the professional study.
| Oxycodone Cutoff = 100 ng/mL | |||
|---|---|---|---|
| Number Tested | Positive | Negative | |
| Conc. (ng/mL) | Site1/ Site2/ Site3 | Site1/ Site2/ Site3 | Site1/ Site2/ Site3 |
| 0 | 15/15/15 | 0/0/0 | 15/15/15 |
| 25 | 15/15/15 | 0/0/0 | 15/15/15 |
| 50 | 15/15/15 | 2/0/1 | 13/15/14 |
| 100 | 15/15/15 | 15/12/12 | 0/3/3 |
| 125 | 15/15/15 | 15/13/14 | 0/2/1 |
| 150 | 15/15/15 | 15/15/15 | 0/0/0 |
b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
No calibrators are required. The device is calibrated during the manufacturing process.
Controls are required but are not specified in the labeling. Users are instructed to follow federal. state and local guidelines concerning QC practices.
Traceability is not covered in the submission.
-
d. Detection Limit:
This information appears in the precision section above. -
e. Analytical specificity:
Cross-Reactivity:
The following metabolites and compounds were initially dissolved in appropriate solvents and then added at varying concentrations to drug-free urine for evaluation. Samples were evaluated in triplicate by in-house operators. Results are expressed as the minimum concentration of metabolite
4
or compound required to produce a positive test result. Percent cross reactivity of a compound is calculated by dividing the cutoff concentration by the minimum concentration required to obtain a positive result and then multiplying by 100%.
| Oxycodone, cutoff = 100 ng/mL | Result | % Cross-Reactivity |
|---|---|---|
| Positive at 100 ng/mL | 100% | |
| Apomorphine | Negative at 100,000 ng/mL |