(53 days)
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card.
A. Test Strip
Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below:
B. Test Card Format
The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below.
The provided submission describes a medical device, the Rapid Methadone Test Strip and Rapid Methadone Test Card, which are immunochromatography-based one-step in vitro tests for the qualitative determination of methadone in human urine specimens above a cutoff level of 300 ng/ml.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria for accuracy, sensitivity, or specificity in the way it might for a diagnostic imaging device. Instead, it states that the devices demonstrate performance characteristics that are "substantially equivalent" to a predicate device, the Applied Biotech SureStep™ Drug Screen Test Methadone. This implies that the acceptance criteria are met if the new device's performance aligns with or is comparable to that of the predicate device.
However, based on the general understanding of drug screening tests, the primary performance metrics are Sensitivity (ability to correctly identify positive samples) and Specificity (ability to correctly identify negative samples). The document mentions "Sensitivity Accuracy" and "Specificity" in the list of studies performed.
Since specific quantitative acceptance criteria are not provided in the document, we will infer the reported device performance based on the claim of substantial equivalence to the predicate. To fully understand the acceptance criteria and corresponding performance, one would typically need access to the predicate device's performance data or a more detailed study report.
| Performance Metric | Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|---|
| Sensitivity | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Specificity | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Accuracy (Overall) | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Precision | Consistent results as demonstrated in internal studies | Studies performed, results imply acceptable precision for substantial equivalence |
| Reproducibility | Consistent results across different tests/batches | Studies performed, results imply acceptable reproducibility for substantial equivalence |
| Stability (Specimen) | Maintenance of performance over time with stored specimens | Studies performed, results imply acceptable stability |
| Stability (Product) | Maintenance of performance over shelf-life | Studies performed, results imply acceptable stability |
| Interference | Minimal interference from common substances | Studies performed, results imply acceptable performance in presence of potential interferents |
2. Sample Size Used for the Test Set and Data Provenance
The submission states: "Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Methadone Test Strip and Rapid Methadone Test Card."
- Sample Size: The specific number of "clinical urine specimens" or "urine control specimens" used for the test set is not provided in the given text.
- Data Provenance: The provenance is "clinical urine specimen," implying human samples. The country of origin is not specified. The samples are likely retrospective as they are referred to as "clinical urine specimens" that were "tested," which typically refers to samples collected prior to the study for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The submission states: "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) is the reference method for confirming methadone presence.
- Number of Experts: The document does not specify the number of experts.
- Qualifications of Experts: The document does not explicitly state the qualifications of individuals performing the GC/MS analysis. However, GC/MS is a laboratory-based method typically performed by trained laboratory technicians or chemists with expertise in analytical chemistry and toxicology. It's not a visually interpreted test like radiology, so "experts" in the typical sense of a clinician making a diagnosis from an image are not directly applicable here for ground truth establishment.
4. Adjudication Method for the Test Set
The adjudication method relies on a "more specific chemical method, such as GC/MS," for confirmation.
- Adjudication Method: GC/MS (or similar confirmatory chemical method) is used as the gold standard for ground truth. This is a definitive analytical process and doesn't typically involve human "adjudication" in the same way as, for example, multiple radiologists reviewing an image. Therefore, a 2+1 or 3+1 method is not applicable here. The GC/MS result is considered the definitive truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The device is an in-vitro diagnostic test strip/card, not an imaging AI device that assists human readers. Its output is a qualitative visual result (presence/absence of a colored band), not an interpretation for a human reader to improve upon.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable as it's not an AI assistance tool for human interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
- Was a standalone study done? Yes, effectively. The "Rapid Methadone Test Strip" and "Rapid Methadone Test Card" are themselves standalone devices. They produce a qualitative result (presence or absence of a colored band) that is then read by a user. The performance studies listed (Sensitivity Accuracy, Specificity, Precision, Reproducibility, etc.) are evaluating the device's inherent ability to detect methadone in urine, independent of "human-in-the-loop" assistance for interpretation, beyond simply reading the test result. The "algorithm" here is the immunochromatographic reaction itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for confirming methadone presence is established by a "more specific chemical method, such as GC/MS." This falls under laboratory-based analytical confirmation / definitive analytical truth.
8. Sample Size for the Training Set
The document does not explicitly mention a training set for the device. Given that this is an immunochromatographic test, the "training" for such a device typically refers to the development and optimization of the reagents (antibodies, conjugates, etc.) and manufacturing processes, rather than a data-driven machine learning algorithm that requires a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned in the context of machine learning, this question is not applicable. The ground truth for developing and optimizing the assay components would have been established through controlled experiments and analytical methods, similar to how the final test set's ground truth is established (e.g., using known concentrations of methadone or GC/MS on samples).
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510 (k) SUMMARY (21 CFR PART 807.92)
Product
Rapid Methadone Test Strip and Rapid Methadone Test Card
Name of Manufacturer
Rapid Diagnostics, Division of ICN BIOmedicals Inc. 1429 Rollins Road, Burlingame, CA 94010, U.S.A.
Principle
The RapidMTD test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-methadone antibody between methadone-protein conjugate and free drug which may be present in the urine specimen being tested.
When methadone is present in the urine specimen, it competes with methadone-protein conjugate for the limited amount of antibody-colloidal conjugate. When the amount of methadone is equal or more than the cut-off, it will prevent the binding of methadone-protein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
Intended Use
The RapidMethadone Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of methadone in human urine specimen above the cutoff level of 300 ng/ml.
Performance
The studies performed are listed below:
Rapid Methadone Test Strip Sensitivity Accuracy (comparison study of clinical urine specimens) Stability - Specimen
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Stability – Product Precision Reproducibility Specificity Interference
Rapid Methadone Test Card Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Methadone Test Strip and Test Card
Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Methadone Test Strip and Rapid Methadone Test Card.
The results of performance characteristics demonstrate Rapid Methadone Test Strip and Rapid Methadone Test Card to be substantially equivalent to the Applied Biotech SureStep ™ Drug Screen Test Methadone, which received 510 (k) approval.
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PRODCUT DESCRIPTION
Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card.
A. Test Strip
Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below:
Image /page/2/Figure/5 description: The image shows a diagram of a lateral flow assay strip. The strip is divided into four sections: an absorbent pad, a coated membrane, a gold conjugate pad, and a sample pad. The absorbent pad is at the top of the strip, and the sample pad is at the bottom.
B. Test Card Format
The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below.
Image /page/2/Figure/8 description: The image shows a diagram of a test strip, likely for a medical or scientific assay. The diagram labels three key areas: the "Control Band," the "Test Band," and the "Sample Well." These labels indicate the regions where control reactions, test results, and sample application occur, respectively, on the strip.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administra 2098 Gaither Road Rockville MD 20850
Mr. Charles Yu Director of Technical Operation Official FDA Correspondent ICN Biomedicals, Inc. Rapid Diagnostics 1429 Rollins Road Burlingame, CA 94010
K023252 Re:
Trade/Device Name: Rapid Methadone Test Card Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: September 23, 2002 Received: September 30, 2002
Dear Mr. Yu:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment page 5
INDICATIONS FOR USE STATEMENT
510 (K) number (if known): _ K023252_ .. _____________________________________________________________________________________________________________________________________
Device Name: Rapid Methadone Test Strip
Indications for Use:
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
ﻢ Prescription Use: (Per 21 CFR 801.109)
OR
Over the Counter Use:
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Attachment page
INDICATIONS FOR USE STATEMENT
510 (K) number (if known): K023252
Device Name: Rapid Methadone Test Card
Indications for Use:
Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Alan Cooper
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023252
Prescription Use: (Per 21 CFR 801.109)
OR
Over the Counter Use:
§ 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).