(49 days)
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No
The summary describes a standard immunoassay for drug detection and contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
This device is an immunoassay for detecting substances in urine, which assists in screening and diagnosis, but does not provide therapy or treatment.
Yes
The intended use statement explicitly mentions "diagnosis of clinical symptoms associated with the use of drugs," indicating its role in identifying a medical condition.
No
The device is described as an immunoassay for the qualitative detection of TCA in human urine. Immunoassays are laboratory tests that typically involve physical reagents and equipment to perform the analysis. The description does not mention any software component or function.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the qualitative detection of TCA in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information for diagnosis or screening.
- Anatomical Site: The anatomical site is "human urine," which is a biological sample.
- Intended User / Care Setting: The intended user is "Professional use," which is typical for IVD devices used in clinical or laboratory settings.
The core function of the device is to analyze a biological sample in vitro to provide information relevant to a medical condition (drug use and associated symptoms), which is the definition of an IVD.
N/A
Intended Use / 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
Product codes
LFG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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)