(96 days)
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Not Found
No
The summary describes a qualitative immunoassay for drug screening in urine, which is a standard laboratory technique and does not mention any AI/ML components or image processing.
No
This device is an immunoassay for detecting tricyclic antidepressants in urine, used for drug screening. It is a diagnostic device, not a therapeutic one as it does not treat or prevent disease.
Yes
The device is described as an "Immunoassay for the qualitative detection of Tricyclic Immunoassay... in human urine to assist in screening of drug of abuse samples," which indicates it is used to identify a condition (presence of a substance) in a biological sample, a characteristic of a diagnostic device.
No
The device is described as an immunoassay for detecting a substance in human urine. This implies a physical test kit or laboratory equipment is involved, not solely software.
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 Tricyclic Immunoassay for the quarteline... in human urine". This describes a test performed in vitro (outside the body) on a biological sample (human urine) to provide diagnostic information (detection of a substance).
- Anatomical Site: The anatomical site is listed as "human urine", which is a biological sample used for in vitro testing.
These are key characteristics of an IVD. The lack of information in other sections (Device Description, Performance Studies, etc.) does not negate its classification as an IVD based on the intended use and sample type.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.
Product codes
LFH, LFI, 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
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Indicated Patient Age Range
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Intended User / Care Setting
Professional use: X Prescription Use X
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle, with its wings outstretched.
AUG 25 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kang, Ph.D. Jemo President Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139
Re : K981801 AccuSign® TCA Requlatory Class: II Product Code: LFH, LFI, LFG Dated: July 31, 1998 Received: August 4, 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 requlatory 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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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 notethe 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 Gutman
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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32-274-1010
Page
.0(k) Number (if known): k 981801
Device Name: AccuSign TCA
Indications For Use:
Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.
(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 281801 510(k) Number _
Professional use: X Prescription Use X Tor 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)