(49 days)
Immunoassay for the qualitative detection of TCA in human urine to assit in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs
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This document is a letter from the FDA regarding the 510(k) premarket notification for the "AccuSign® TCA-Rapid One-Step Tricyclic Antidepressant Assay" device. It does not contain the detailed study information required to fill out the table and answer all questions related to acceptance criteria and device performance.
The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to predicate devices, allowing it to be marketed. It does not provide the performance data that would typically be found in a 510(k) summary or the actual study report.
Therefore, I cannot provide a detailed response to most of your questions based on the provided text.
Here's what can be inferred or stated about the information requested, with limitations:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not contain acceptance criteria or performance data for the AccuSign TCA device. It only states that the device was found substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from this document. This information would be in the 510(k) submission, not 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)
- Cannot be determined from this document. This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined from this document. This information is not provided.
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 / Cannot be determined. This device is an immunoassay for drug detection, not an AI-assisted diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes (for the device itself). The AccuSign TCA is a rapid one-step immunoassay. By its nature, it performs its function (detecting TCA in urine) without human interpretation in the sense of a radiologist reading an image. The result is typically a visual readout (e.g., lines on a test strip). Its performance would be evaluated in a standalone manner, though this document doesn't provide the results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Most likely a reference method for drug testing. For a drug assay, the ground truth would typically be established by a highly accurate and precise laboratory method, such as Gas Chromatography-Mass Spectrometry (GC-MS) or High-Performance Liquid Chromatography (HPLC), which are considered gold standards for identifying and quantifying substances in biological samples. However, this is an inference based on the type of device, not information directly from the document.
8. The sample size for the training set
- Cannot be determined from this document. This information is not provided. (Note: For immunoassay devices, a "training set" in the machine learning sense is typically not applicable. Instead, "validation batches" and "calibration" are more common terms, but the underlying data used to establish performance is still relevant).
9. How the ground truth for the training set was established
- Cannot be determined from this document. (See #7 and #8 for context regarding "training set" for this type of device).
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Image /page/0/Picture/1 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized design consisting of three overlapping, curved shapes that resemble a stylized caduceus without the staff.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 1998
Jemo Kang, Ph.D. Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139
Re : K980249 AccuSign® TCA-Rapid One-Step Tricyclic Antidepressant Assav Regulatory Class: II Product Code: LFG Dated: January 16, 1998 Received: January 23, 1998
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 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 Requlations, 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 requlations.
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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 qeneral 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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| A BANDAR PORTULAR | |
|---|---|
| 510(k) Number (if known): | K980249 |
|---|---|
| --------------------------- | --------- |
Device Name: AccuSign TCA
Indications For Use:
Immunoassay for the qualitative detection of TCA in human urine to assit 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 Laborato
510(k) Number
Professional use: X
Prescription Use: × Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).