BIONIKE AQ PHENCYCLIDINE (PCP) TEST by BIONIKE LABORATORIES, INC.

Bionike's AQ™ Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 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 indicated". Bionike Laboratories' AQ™ Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Device Description

Bionike Laboratories' AQ™ Phencyclidine (PCP) 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 detection level of 25 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

1. Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Relative Sensitivity	100%	100%
Relative Specificity	100%	100%
Accuracy	100%	100%

Note: The document states the device "yielded relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100%," implying these were the target acceptance criteria.

2. Sample Size and Data Provenance

Test Set Sample Size: 286 samples
Data Provenance: Not explicitly stated, but based on the "clinical trial" wording, it suggests prospective collection for the purpose of the study. The absence of specific country information usually implies domestic (US) data for FDA submissions unless otherwise mentioned.

3. Number of Experts and Qualifications

Not applicable. The ground truth was established by laboratory methods (chemical analysis) rather than expert human interpretation of images or clinical cases.

4. Adjudication Method

Not applicable. The ground truth was established by laboratory methods, not through reconciliation of multiple human readers.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The Bionike AQ™ Phencyclidine (PCP) Test's performance (sensitivity, specificity, accuracy) was evaluated directly against a reference method (Syva EMIT® (25) II, confirmed by GC/MS).

7. Type of Ground Truth Used

The primary ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) at a cutoff of 25 ng/ml. Syva EMIT® (25) II was used as an initial comparator, but GC/MS served as the definitive confirmation method.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device development. The reported performance refers to the in-house testing and a clinical trial. Given the nature of a rapid immunoassay, it's more likely that the device's design and operating parameters were established through iterative development and testing, rather than a distinct machine learning "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable, as a distinct training set in the context of machine learning is not described. For the device's development/optimization (analogous to training), it's implied that various samples with known PCP concentrations (likely determined by GC/MS or similar precise analytical methods) would have been used during the research and development phases to establish the assay's sensitivity, specificity, and cutoff levels.

Summary

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K993945

510k Submission for Bionike AQ™ Phencyclidine (PCP) Test Bionike Laboratories

Page 91 of 91

Revision A 07/06/99 Printed on 10/04/99 11:20 AM

Summary of Safety and Effectiveness

The sponsor, Bionike Laboratories, Inc. (1015 Grandview Drive, 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 Phencyclidine (PCP) and its metabolites in a screening format.

The trade name of the device is Bionike AQ™ Phencyclidine (PCP) Test having a designated common name of Phencyclidine (PCP) Test System and a classification as a Class II device per FDA. This device is intended for the medical/forensic screening of urine.

In-house testing of Bionike AQ™ Phencyclidine (PCP) Test yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against Syya EMIT® (25) II on samples documented to be positive by GC/MS. A clinical trial consisting of 286 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II® run at 25 ng/ml. Non parametric testing failed to demonstrate any significant difference from one another. Both Emit II and Bionike AQ™ PCP yielded 2 false positives due to the presence of Phencyclidine (PCP) at levels below 25 ng/ml, but above 20 ng/ml as determined by GC/MS.

All samples by either screening method were confirmed by GC/MS (25 nemi. The testing performed by the Clinical Trial site did find 2 false positives but no false negatives in the samples tested. The false positives were due to the presence of phencyclidine (PCP) between 20 and 25 ng/ml by GC/MS.

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.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged around the border of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 7 1999

James M. Barquest, Ph.D. c/o California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, California 94234

Re: K993945

Trade Name: Bionike AQ™ Phencyclidine (PCP) Test Regulatory Class: II Product Code: LCM Dated: October 29, 1999 Received: November 19, 1999

Dear Dr. Barquest:

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 Sutman

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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1993945

510(k) Number (if Known): Not Yet Assigned

Device Name: AQ™ Phencyclidine (PCP) assay

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

lan cooper

(Division Sign-Off)
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Division of Clinical Laboratory Devices
510(k) Number K993945

Prescription Use: (Per 21 CFR 801.109

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

Regulation Number and Section

N/A