(286 days)
Not Found
No
The device description details a rapid immunochromatographic assay based on competitive binding, which is a standard biochemical method and does not involve AI or ML. The performance studies describe comparison to GC/MS, a traditional analytical technique. There is no mention of AI, ML, or related concepts in the provided text.
No
This device is a diagnostic test kit used to detect a metabolite of methadone, not to treat a condition.
Yes
This device is a rapid immunochromatographic assay for the qualitative detection of EDDP, which is an inactive metabolite of methadone. It provides a preliminary result for drug detection, which is a form of diagnostic information used in healthcare.
No
The device description clearly describes a physical test strip that utilizes immunoassay principles and capillary action to produce a visual result. This involves hardware components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP)... in the urine specimen." 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 substance within that sample.
- Device Description: The description details an "immunoassay based on the principle of competitive binding" using "urine specimen." This further confirms it's a test performed on a biological sample in a laboratory or point-of-care setting.
- Performance Studies: The performance studies involve comparing the device's results to a reference method (GC/MS) using "urine specimens" from "external clinical study sites." This is typical for validating the performance of an IVD.
- Predicate Devices: The listed predicate devices (K012595, K023617, K081378) are all known IVD devices for drug testing.
The device is designed to be used in vitro (outside the body) to analyze a biological sample (urine) for the presence of a specific substance (EDDP), which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic immunoassay for the qualitative detection of 2-ethylidene-1,5dimethyl-3.3-diphenylpyrrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.
This assay provides only a preliminary 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. particularly when preliminary positive results are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DJR
Device Description
The One Step EDDP (Methadone Metabolite) Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of anti-EDDP antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region. This confirms sufficient specimen volume, adequate membrane wicking and correct.
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
professional use and professionals at point of care sites.
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 drug-free urine pool was spiked with EDDP at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, 450 ng/mL and 900 ng/mL.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the One Step EDDP (Methadone Metabolite) Test Strip was evaluated and compared to GC/MS by three external clinical study sites, with 3 different employees performing the testing.
Overall % Agreement with GC/MS is 98%.
The results demonstrate >99% accuracy at 50% above and 50% below the cut-off concentration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Over All Agreement With GC/MS Analysis: 98% (538/5549) (96% - 99%)*
Accuracy: Clinical Site 1: 98% (180/183) (95% - 100%)*
Accuracy: Clinical Site 2: 98% (179/183) (94% - 99%)*
Accuracy: Clinical Site 3: 98% (179/183) (90% - 97%)*
Analytical Sensitivity:
At 0 ng/mL EDDP concentration, 100% negative results (90/90).
At 150 ng/mL EDDP concentration, 100% negative results (90/90).
At 225 ng/mL EDDP concentration, 100% negative results (90/90).
At 300 ng/mL EDDP concentration (Cut-off), 56.7% negative (51/90) and 43.3% positive (39/90).
At 375 ng/mL EDDP concentration, 15.6% negative (14/90) and 84.4% positive (76/90).
At 450 ng/mL EDDP concentration, 100% positive results (90/90).
At 900 ng/mL EDDP concentration, 100% positive results (90/90).
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
5. 510(k) Summary
APR 1 9 2010
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is:_K092048
Submitter:
Biosite, Inc. 9975 Summers Ridge Road San Diego, California 92121 Tel.: 858-805-2278 Fax: 858-695-7100
Date:
April 12, 2010
Contact Person:
Lisa Chicorka
Product Names:
One Step EDDP (Methadone Metabolite) Test Strip
| Common Name: | Immunochromatographic Test for the 2-ethylidene-1,5-dimethyl-
3,3-diphenylpyrrolidine (EDDP) in urine |
|----------------------------|----------------------------------------------------------------------------------------------------------|
| Regulation Name: | Methadone Test System |
| Product Code: | DJR |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 862.3620 |
1
Intended Use
Step EDDP (Methadone Metabolite) Test Strip is a rapid The One immunochromatographic immunoassay for the qualitative detection of 2-ethylidene-1,5dimethyl-3.3-diphenylpyrrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.
This assay provides only a preliminary 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. particularly when preliminary positive results are indicated.
Description:
The One Step EDDP (Methadone Metabolite) Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of anti-EDDP antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region. This confirms sufficient specimen volume, adequate membrane wicking and correct
Comparison to a Predicate Device:
The predicate devices, ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device (K012595) are intended for the detection of Methadone in urine with a cutoff of 300 ng/mL. The One Step EDDP (Methadone Metabolite) Test Strip is to be used for the detection of the Methadone Metabolite EDDP at a cutoff of 300 ng/mL. The same test principle and technology of these rapid diagnostic tests enables substantial equivalence. Another predicate device, the DRI Methadone Metabolite Enzyme Assay (K023617), is a Liquid Homogeneous Enzyme Assay which detects EDDP with results being obtained spectrophotometrically. Although the test principle differs, the same metabolite is to be detected at the same cut-off (300 ng/mL) as does the One Step EDDP (Methadone Metabolite) Test Strip. Therefore, the DRI Methadone Metabolite Enzyme Assay is also used in the substantial equivalence discussion.
2
A predicate device with identical technology is K081378 -Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels., which are rapid immunochromatographic immunoassays for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine with a cutoff of 100 ng/mL (EDDP) (and other drugs). The submitter is Applied DNA Technologies Inc. BioClinical Performance Data of the One Step EDDP (Methadone Metabolite) Test Strip was compared with the reference method GC/MS and the DRI® Methadone Metabolite Assay (cutoff 300 ng/mL) manufactured by Microgenics, Inc.
Performance Characteristics
The One Step EDDP (Methadone Metabolite) Test Strip was evaluated to determine the performance characteristics of the test. Various studies were performed to determine the Analytical Sensitivity, Cross Reactivity, Interference Substances, Urinary pH, Urinary Specific Gravity, Reading Time Flexibility, Sample Flexibility, Temperature Flexibility, Specimen Storage, Recovery, Stability, POL Study and Clinical Study.
Accuracy
The performance of the One Step EDDP (Methadone Metabolite) Test Strip was evaluated and compared to GC/MS by three external clinical study sites, with 3 different employees performing the testing.
| Method | Specimen Cut-off Range by GC/MS Analysis | % Agreement with GC/MS Analysis | ||||||
|---|---|---|---|---|---|---|---|---|
| Negative | Low negative (+50% cutoff) | |||||||
| Clinical Site | Positive | 0 | 0 | 3 | 8 | 70 | 98% (180/183) | |
| Negative | 100 | 1 | 1 | 0 | 0 | (95% - 100%)* | ||
| EDDP Test Strip | Clinical Site | Positive | 0 | 0 | 4 | 8 | 70 | 98% (179/183) |
| Negative | 100 | 1 | 0 | 0 | 0 | (94% - 99%)* | ||
| Positive | 0 | 0 | 4 | 8 | 70 | 98% (179/183) | ||
| Clinical Site | Negative | 100 | 1 | 0 | 0 | 0 | (90% - 97%)* | |
| Over All Agreement With GC/MS Analysis | 98% (538/5549) | |||||||
| (96% - 99%)* |
| Table 1 | One Step EDDP (Methadone Metabolite) Test Strip vs. GC/MS Analysis | |||
|---|---|---|---|---|
- Denotes 95% confidence intervals Overall % Agreement with GC/MS is 98%.
Analytical Sensitivity
3
A drug-free urine pool was spiked with EDDP at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, 450 ng/mL and 900 ng/mL. The results demonstrate >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
| EDDP
Concentration
(ng/mL) | Percent of
Cut-off | n | Visual Result | |
|----------------------------------|-----------------------|----|---------------|----------|
| | | | Negative | Positive |
| 0 | 0% | 90 | 90 | 0 |
| 150 | -50% | 90 | 90 | 0 |
| 225 | -25% | 90 | 90 | 0 |
| 300 | Cut-off | 90 | 51 | 39 |
| 375 | +25% | 90 | 14 | 76 |
| 450 | +50% | 90 | 0 | 90 |
| 900 | +300% | 90 | 0 | 90 |
| Table 2 One Step EDDP (Methadone Metabolite) Test Strip | |||||
|---|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------------- | -- | -- |
Risk Analysis
Risk analysis was performed on the One Step EDDP (Methadone Metabolite) Test Strip and results were found acceptable.
Conclusion:
The One Step EDDP (Methadone Metabolite) Test Strip is a rapid chromatographic immunoassay for detection of Methadone Metabolite in human urine at a designated cutoff concentration of 300 ng/mL. The EDDP Test Strip is used to provide only a preliminary analytical result. All positive test results obtained with this device must be confirmed by another test method, preferably GC/MS. It is intended for healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.
!..
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Biosite, Inc. c/o Lisa Chicorka 9975 Summers Ridge Road San Diego, CA 92121
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
APR 1 9 2010
Trade Name: One Step EDDP (Methadone Metabolite) Test Strip Regulation Number: 21 CFR §862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Codes: DJR Dated: April 12, 2010 Received: April 13, 2010
Dear Ms. Chicorka:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
.
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Indications for Use
510(k) Number (if known): K092048
Device Name: One Step EDDP (Methadone Metabolite) Test Strip
Intended Use
The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic assay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.
This assay provides only a preliminary 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, particularly when preliminary positive results are indicated.
Prescription Use X (21 CFR Part 801 Subpart D)
Over the
. . . . . . . . . . . . . .
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
And/Or
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092048