(52 days)
VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE 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, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.
VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (VERDICT®-II PROPOXYPHENE ) |
|---|---|
| Rapid, qualitative detection of propoxyphene and its metabolite (norpropoxyphene) in human urine. | The device provides rapid, qualitative detection of propoxyphene and norpropoxyphene in human urine. |
| Detection of norpropoxyphene at 300 ng/mL. | The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The adjudication method is not mentioned in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size of human reader improvement with AI assistance, is provided in the document. This is an in vitro diagnostic device, and such studies are typically not performed for this type of product.
6. Standalone Performance (Algorithm Only)
The device, VERDICT®-II PROPOXYPHENE, is described as a "one-step immunochromatographic test." This indicates it's a physical test kit, not an algorithm, and therefore the concept of standalone (algorithm-only) performance does not apply. The document does state that the test provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS). This implies the device's performance is as a screening tool, not a definitive standalone diagnostic.
7. Type of Ground Truth Used
The document explicitly states that the device provides "only a preliminary analytical test result" and that "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." This indicates that the ground truth for validating the device's performance would be established by a "gold standard" confirmatory method like GC/MS.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document focuses on the device's indications for use and substantial equivalence to a predicate device. It does not detail the specific methodology for establishing ground truth for any training set. However, given the nature of the device (a rapid screening test for drug detection) and the mention of GC/MS as a confirmatory method, it's highly probable that samples with known concentrations of propoxyphene and norpropoxyphene (likely confirmed by methods like GC/MS) would be used to develop and validate such a test.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the snakes intertwined around a staff.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850.
Mr. Michael Turanchik Director, Research and Development MEDTOX Diagnostics, Inc. 1238 Anthony Road Burlington, NC 27215
Re:
K020787 R020707
Trade/Device Name: VERDICT® -II PROPOXYPHENE Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxphene test system Regulatory Class: Class II Product Code: JXN Dated: March 8, 2002 Received: March 11, 2002
Dear Mr. Turnachik:
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.
MAY 0 2 2002
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT III VERDICT®-II PROPOXYPHENE 510(k) Submission
INDICATIONS FOR USE FORM
510(k) Number (if known): _ KO20787
Device Name: VERDICT®-II PROPOXYPHENE
Indications for Use:
VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale.
VERDICT®-II PROPOXYPHENE 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, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) the text in the image is:
tan Coopes
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number. K020787
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).