ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

K983147 · Princeton BioMeditech Corp. · DKE · Sep 28, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983147
• Device Name: ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
• Applicant: Princeton BioMeditech Corp.
• Product Code: DKE · Clinical Toxicology
• Decision Date: Sep 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

Device Story

AccuSign® DOA 8 is a rapid, one-step immunoassay panel for qualitative detection of eight drug classes (THC, OPI, COC, AMP, BZO, BAR, TCA, PCP) in human urine. Device used by healthcare professionals in clinical settings to screen for drugs of abuse. Principle of operation involves lateral flow immunoassay technology; urine sample migrates across test strip; presence of specific drugs competes with drug-conjugate for antibody binding sites. Visual readout provided by appearance or absence of colored lines on test membrane. Results assist clinicians in identifying potential substance use, facilitating further diagnostic or clinical decision-making.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; multi-panel test format for 8 drug classes; urine specimen matrix; professional use diagnostic device.

Indications for Use

Indicated for qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine for drug of abuse screening. For professional, prescription use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 8 1998

Jemo Kang, Ph.D. . President Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139

Re: K983147 AccuSign® DOA 8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP) Rapid One-Step Drugs of Abuse Panel Test Regulatory Class: II Product Code: DKE, DKZ, LFI, DJG, DIS, LCM, DIO, DKN September 3, 1998 Dated: Received: September 8, 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, qood 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 Regulations, Title 21, Parts 800 to 895. ਨੇ 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 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 [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 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 [phone] or [phone] 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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Page **_ / of _** /

.10(k) Number (if known): k983147

Device Name:___AccuSign® DOA 8 (THC/OPVCOC/AMP/BZO/BAR/TCA/PCP)

Indications For Use:

Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 498547

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Concurrence of CDRH Office of Device Evaluation (ODE)

| Professional Use: | X |
|-------------------|---|
| Prescription Use: | X |

Per 21 CFR 801.109)

OR

Over The Counter Use: ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)