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 Description

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.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Bionike AQ™ Barbiturate Test:

Acceptance Criteria and Device Performance Study

The Bionike AQ™ Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine. The device's performance was evaluated against a predicate device (Syva EMIT® II) and confirmed by Gas Chromatography/Mass Spectrophotometry (GC/MS).

1. Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Relative Sensitivity (Agreement within positives)	High (close to 100%)	97.96% (clinical trial)
Relative Specificity (Agreement within negatives)	High (close to 100%)	100% (clinical trial)
Accuracy	High (close to 100%)	98.99% (clinical trial)

Note: The document does not explicitly state numerical "acceptance criteria" but rather presents the "reported device performance" from a clinical trial, implying these values met the sponsor's internal criteria for submission.

2. Sample Size and Data Provenance

Test Set Sample Size: 296 samples for the clinical trial.
Data Provenance: Not explicitly stated, but the mention of a "clinical trial" generally implies prospective data collection from human subjects. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory methods.

4. Adjudication Method for the Test Set

Adjudication method not applicable in this context. The study primarily compares the device's output to laboratory-derived ground truth (GC/MS) rather than expert consensus on a diagnostic outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a diagnostic assay, not an imaging device requiring human interpretation, so AI assistance for human readers is not relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported performance metrics (sensitivity, specificity, accuracy) are for the Bionike AQ™ Barbiturate Test itself, operating without human-in-the-loop performance modifications for interpreting the test result. The device produces a qualitative result (presence or absence of a color band).

7. Type of Ground Truth Used

Primary Ground Truth: Gas Chromatography/Mass Spectrophotometry (GC/MS). This is considered the "gold standard" for confirming the presence and concentration of drugs in biological samples.
Initial Comparison: The device was also tested against Syva EMIT® II, a predicate screening method, but GC/MS served as the definitive confirmation for all positive samples.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The product description implies an in-house testing phase before the clinical trial, but no details on sample size or methodology for this phase are provided beyond stating, "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." This suggests that the device's development and initial calibration (what might be considered "training") were based on internal data, potentially including samples confirmed by GC/MS, but the specific sample size for this internal "training" is not given.

9. How Ground Truth for the Training Set Was Established

Based on the in-house testing description, the ground truth for samples used in development (training) would have been established by comparison to the Syva EMIT® II method, and critically, through confirmation by GC/MS for samples documented as positive. This is the same method used for the clinical trial's ground truth. However, specific details about the samples or the process for the "training set" are not provided.

Summary

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Revision A 01/10//99Printed on 01/26/1999

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.

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 (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 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/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:

(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

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

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
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.(b)
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).