BIONIKE AQ BARBITURATE TEST

K990280 · Bionike, Inc. · DIS · Jun 28, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990280
• Device Name: BIONIKE AQ BARBITURATE TEST
• Applicant: Bionike, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Jun 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

Bionike Laboratories' AQ™ Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Bionike Laboratories' AQ™ Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

Device Story

AQ™ Barbiturate Test is a chromatographic absorbent immunoassay for urine screening. Input: urine sample. Principle: competitive binding; drug/metabolites in sample compete with immobilized drug conjugate on porous membrane for limited antibody sites. Labeled antibody-dye conjugate binds to free drug, forming antibody-antigen complex. Result: absence of magenta band at positive reaction zone indicates drug level >200 ng/ml; control zone magenta band confirms reagent/device function. Used in clinical/forensic settings. Output: visual colorimetric result interpreted by healthcare provider. Preliminary positive results require GC/MS confirmation. Benefits: rapid screening for presence of barbiturates to inform clinical decision-making.

Clinical Evidence

Clinical trial of 296 samples. Results: relative sensitivity 97.96%, relative specificity 100%, accuracy 98.99%. In-house testing yielded 100% sensitivity, specificity, and accuracy compared to Syva EMIT® II. All positive results confirmed by GC/MS.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive binding immunoassay. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative screening of urine for Barbiturates and metabolites at a 200 ng/ml cutoff. Intended for medical/forensic screening; not for monitoring drug levels. Preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

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

Reference Devices

• Syva EMIT® II

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

The sponsor, Bionike Laboratories, Inc. (1015 Grandview, South San Francisco. CA 94080-4910) has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Barbiturate and its metabolites in a screening format.

The trade name of the device is Bionike AQ™ Barbiturate Test having a designated common name of Barbiturate Test System and a classification as a Class II device per 21 CFR ¶ 862.3150. This device is intended for the medical/forensic screening of urine.

Bionike Laboratories' AQ™ Barbiturate Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the cutoff level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

In-house testing of Bionike Laboratories' AQ™ Barbiturate Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 296 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 97.96%, a relative specificity or agreement within negatives of 100% with an accuracy of 98.99%.

All positive samples by either screening method were confirmed by GC/MS. Four of the 3 samples were negative for Barbiturate, but positive for other drugs by GC/MS. The three samples were positive for either Bromocriptine or Zoloft.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.

> P:\BioNike\DrugsAbuse\Barbiturates\BNBarbs510k.doc, Dr. Cleve W. Laird, Last Saved by 01/26/99 11:57 AM

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## JUN 2 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionike, Inc. c/o Dr. Cleve W. Laird Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065

Re: K990280 Trade Name: AQ™ Barbiturate Test Regulatory Class: II Product Code: DIS Dated: May 18, 1999 Received: May 20, 1999

#### Dear Dr. Laird:

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 legally marketed predicate 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 Regulations, 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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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## 510(k) Number (if Known): To be Assigned

Device Name: AQ™ Barbiturate Test

### Indications For Use:

Bionike Laboratories' AQ™ Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Bionike Laboratories' AQ™ Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dean Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices 990280 510/k) Number

**Prescription Use:**
(Per 21 CFR 801.109

or

Over The Counter Use: (Optional Format 1-2-96)