Syntron's QuikPac II One Step Opiate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiate in urine at the cutoff level of 300 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. Syntron's QuikPac II One Step Opiate Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiate and its metabolites.

Device Description

Syntron's QuikPac II One Step Opiate 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 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 300 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 regarding the QuikPac II One Step Opiate Test, focusing on acceptance criteria and supporting study data:

Acceptance Criteria and Device Performance for QuikPac II One Step Opiate Test

The QuikPac II One Step Opiate Test is a rapid, qualitative, competitive binding immunoassay intended for the determination of Opiate in urine at a cutoff level of 300 ng/ml. The device's performance was evaluated through in-house testing and a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "Sensitivity must be >95%"). Instead, it presents the achieved performance. Based on the "Summary of Safety and Effectiveness," the implied acceptance criteria were likely perfect or near-perfect agreement with the predicate device (Emit II®) and confirmation by GC/MS.

Performance Metric	Implied Acceptance Criteria (Based on reported results)	Reported Device Performance
In-House Testing
Relative Sensitivity	1.000 (100%)	1.000 (100%)
Relative Specificity	1.000 (100%)	1.000 (100%)
Accuracy	100%	100%
Clinical Trial
Relative Sensitivity	100%	100%
Relative Specificity	100%	100%
Accuracy	100%	100%
False Positives	Zero	Zero
False Negatives	Zero	Zero

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Trial): 298 samples.
Data Provenance: The text refers to "in-house testing" and "a clinical trial" as well as an "independent clinical trial." It does not explicitly state the country of origin but given the submitting company (Syntron Bioresearch, Inc.) is in Carlsbad, California, and the FDA submission, it's highly likely the data is from within the United States. The studies appear to be retrospective, as samples were "documented to be positive by GC/MS" and then tested with the device and a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth appears to be established by comparison to Syva EMIT® II and confirmed by GC/MS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an image-based or interpretation-based diagnostic device that typically involves multiple human readers. The comparison was device-to-device (QuikPac II vs. Emit II®) with GC/MS confirmation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance presented is for the device operating in a standalone manner. While the test is read visually, the performance metrics (sensitivity, specificity, accuracy) relate to the device's ability to correctly identify the presence or absence of opiates in comparison to reference methods, without considering a human reader's interpretive variability as a primary outcome. The context implies a direct, objective readout based on the presence or absence of a color band.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

Comparison to a predicate device: Syva EMIT® II.
Confirmatory method: Gas Chromatography/Mass Spectrometry (GC/MS) for all positive samples from either screening method. GC/MS is considered a "gold standard" for drug confirmation.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The reported study appears to be the primary validation study, potentially serving as both internal evaluation and external validation.

9. How the Ground Truth for the Training Set Was Established

Since a separate training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided. If the validation samples were also used for any iterative development, the ground truth would have been established as described in point 7.

Summary

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K 972405

3 1997 HUJ

510k Submission for QuikPac II One Step Opiate Test Syntron Bioresearch, Inc.

Revision A 6/17/97 Printed on 6/24/97

Page 74 of 74 Pages

Summary of Safety and Effectiveness

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West. Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Opiate and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Opiate Test having a designated common name of Opiate Test System and a classification as a Class II device per 21 CFR ¶ 862.3250. This device is intended for the medical/forensic screening of urine.

In-house testing of Syntron's QuikPac II One Step Opiate 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 Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 298 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II®.

All positive samples by either screening method were confirmed by GC/MS. There were no false positive or negative results observed in either the in-house clinical trial or the independent clinical trial.

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 features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue Suite 201 Simi Valley, CA 93065

K972405 Re : QuikPac II One Step Opiate Assay Regulatory Class: II Product Code: DJG Dated: June 24, 1997 Received: June 26, 1997

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 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.

AUG - 8 1997

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 requirement, 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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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 (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/dsmamain.html".

Sincerely yours,
Steven Ditman

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): No Yet Assigned

Device Name: QuikPac II One Step Opiate Assay

Indications For Use:

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

Concurance of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory igrices:
510(k) Number. K972485

Perscription Use:
(Per 21 CFR 801.109

Over The Counter Use: Optional Format 1-2-96}

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).