ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

K981801 · Princeton BioMeditech Corp. · LFH · Aug 25, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981801
• Device Name: ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
• Applicant: Princeton BioMeditech Corp.
• Product Code: LFH · Clinical Toxicology
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Intended Use

Immunoassay for the qualitative detection of Tricyclic Antidepressants (TCA) at cutoff 1000 ng/mL in human urine to assist in screening of drug of abuse samples.

Device Story

AccuSign TCA is an immunoassay for qualitative detection of tricyclic antidepressants in human urine. Device intended for professional, prescription-use screening of drug of abuse samples. Operates via lateral flow immunoassay technology; provides visual qualitative results. Used in clinical or laboratory settings by healthcare professionals to assist in identifying potential drug use. Output is a visual indicator of presence or absence of TCA above 1000 ng/mL threshold. Results aid clinical decision-making regarding patient drug screening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay; qualitative visual detection; 1000 ng/mL cutoff; professional use format.

Indications for Use

Indicated for the qualitative detection of Tricyclic Antidepressants in human urine at a 1000 ng/mL cutoff for professional, prescription-use drug of abuse screening.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

{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.

{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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{2}------------------------------------------------

| 98/20/1998 | 09:15 | 73 |
|------------|-------|----|
|------------|-------|----|

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)