(24 days)
Immunoassay for the qualitative detection of opiates in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs
AccuSign MOP, BioSign MOP, and STATUS DS MOP
The document provided does not contain the detailed information necessary to fully answer all aspects of the request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for three opiate detection devices (AccuSign MOP, BioSign MOP, and STATUS DS MOP), indicating substantial equivalence to a predicate device. It defines the intended use but does not include specific performance study data, acceptance criteria, sample sizes, ground truth establishment, or expert details typical of a detailed performance study report.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided document. An FDA 510(k) clearance letter acknowledges the submission and clearance but typically does not include the detailed performance data or acceptance criteria that were part of the submission.
2. Sample size used for the test set and the data provenance:
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method for the test set:
This information is not present in the provided document.
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:
This is an in-vitro diagnostic device (immunoassay for opiate detection). The concept of "human readers improve with AI vs without AI assistance" is not applicable to this type of device. There's no indication of AI involvement or a human interpretive component in the context of MRMC for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is an in-vitro diagnostic device. Its performance is inherently "standalone" in terms of its ability to detect opiates in urine, as it's an immunoassay. The device itself performs the detection. However, the term "standalone" as used in the context of "algorithm only" or "without human-in-the-loop" typically refers to AI/ML models. While the device operates without continuous human input for each test result, it's not a software algorithm in the AI/ML sense. Performance data for such a device would typically focus on sensitivity, specificity, accuracy, precision, etc., rather than algorithm-only performance. The specifics of these metrics are not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For an immunoassay detecting opiates, the ground truth would typically be established by a reference method for drug detection (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC-MS)) on the same urine samples. However, the specific method used for ground truth is not mentioned in the document.
8. The sample size for the training set:
This information is not present in the provided document. For 510(k) submissions of IVD kits, the concept of a "training set" in the machine learning sense is generally not applicable as these are typically chemical/biological assays, not AI algorithms. Performance is evaluated on clinical samples.
9. How the ground truth for the training set was established:
This information is not present in the provided document. As mentioned above, the concept of a "training set" in this context is not directly applicable.
Summary of what is known from the document:
- Device Name: AccuSign MOP, BioSign MOP, and STATUS DS MOP
- Regulatory Class: II
- Product Code: DJG
- Indications For Use: Immunoassay for the qualitative detection of opiates in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.
- K981771: The 510(k) number for this clearance.
- Clearance Date: June 12, 1998
- Use Type: Professional use and Prescription Use.
To obtain the detailed performance study information, one would typically need to review the original 510(k) submission (K981771) itself, which would contain the test reports and data that led to the substantial equivalence determination. The FDA clearance letter only states that the device was found substantially equivalent, implying that the submitted data met the required criteria.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 2 1998
Jemo Kang, Ph.D. . President Princeton BioMeditech Corporation P.O. Box 7139 08543-7139 Princeton, New Jersey
Re : K981771 AccuSign MOP, BioSign MOP, and STATUS DS MOP Regulatory Class: II Product Code: DJG Dated: May 18, 1998 May 19, 1998 Received:
Dear Dr. Kang:
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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation (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 In addition, FDA may publish further announcements action. 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.
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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/dsmamain.html".
sincerely yours,
Steven Litman
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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| S 10(k) Number (if known): | K981771 |
|---|---|
| ---------------------------- | --------- |
AccuSign MOP Device Name:
Indications For Use:
Immunoassay for the qualitative detection of opiates in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices
K
510(k) Number
Professional use: X Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).