(177 days)
VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale.
VERDICT®-II OPIATES 2000 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 used.
Not Found
Here's an analysis of the provided FDA document regarding the VERDICT®-II OPIATES 2000 device, focusing on acceptance criteria and study details:
This document, an FDA 510(k) clearance letter, primarily establishes that the VERDICT®-II OPIATES 2000 device is substantially equivalent to a legally marketed predicate device. It does not contain detailed information about specific acceptance criteria or a comprehensive study report designed to prove the device meets those criteria with a specified performance metric.
The document does describe the device's intended use and the concentration it detects, which implicitly sets a functional performance expectation.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of sensitivity, specificity, accuracy percentages, or other statistical measures. Instead, it defines the functional capability of the device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Rapid, qualitative detection of opiates (morphine/codeine) | The device is a one-step immunochromatographic test for rapid, qualitative detection of opiates. |
| Detection in human urine | The device detects opiates in human urine. |
| Detection at a cut-off concentration of 2000 ng/mL | The device detects opiates and major metabolites at a cut-off of 2000 ng/mL. |
| Preliminary analytical test result | The device provides only a preliminary analytical test result. |
| Not for over-the-counter sale | Explicitly stated "Not for over-the-counter sale." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. The 510(k) clearance letter does not describe the specific study data (sample size, provenance) used by the manufacturer to demonstrate substantial equivalence. This information would typically be in the full 510(k) submission, not in the FDA's clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not available. The document does not provide details about clinical studies, expert involvement, or the qualifications of such experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available. Since it's an in-vitro diagnostic test for drug detection and not an image-based diagnostic, adjudication methods like N+1 are not typically used in the same way. The document does not describe any specific adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an immunochromatographic test, not an AI-assisted diagnostic device that would involve human readers interpreting AI output. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The VERDICT®-II OPIATES 2000 is an in-vitro diagnostic test. Its performance is evaluated as a standalone product. While the result is "preliminary" and requires confirmation, the device itself operates without continuous human intervention during the test run. The "standalone" performance would be its accuracy, sensitivity, and specificity in detecting opiates at the specified cut-off, although these metrics are not provided in this document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document states: "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 strongly implies that GC/MS is the gold standard (ground truth) for confirming the presence and concentration of opiates.
8. The sample size for the training set
Not available. This device is not an AI/machine learning product that undergoes "training." Its performance is based on the inherent chemical and immunological properties of its components.
9. How the ground truth for the training set was established
Not applicable. See point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three lines representing the staff and a single line representing the snake.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1999
Mr. Michael Turanchik Director of Research and Development MedTox Diagnostics, Inc. 1238 Anthony Road Burlington, North Carolina 27215
Re: K992111
Trade Name: VERDICT® -II OPIATES 2000 Regulatory Class: II Product Code: DJG Dated: November 11, 1999 Received: November 15, 1999
Dear Mr. Turanchik:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman
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
{2}------------------------------------------------
EXHIBIT III - VERDICT-II OPIATES 2000 510(k) Submission
INDICATIONS FOR USE FORM
510(k) Number (if known): K992111
Device Name: VERDICT®-II OPIATES 2000
Indications for Use:
VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale.
VERDICT®-II OPIATES 2000 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 used.
per
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992111
.'
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
§ 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).