Syntron's QuikStrip One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates 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 QuikStrip One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.

Device Description

Syntron's QuikStrip One Step Opiates 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 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 QuikStrip One Step Opiates Test, structured to answer your questions:

Acceptance Criteria and Device Performance Study for QuikStrip One Step Opiates Test

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy. Instead, the device performance is reported and implied to meet the necessary standards for substantial equivalence.

Performance Metric	Implied Acceptance Criteria (Implicit)	Reported Device Performance	Comments
Relative Sensitivity	High (e.g., >90-95%)	100%	For positive samples compared to Syva EMIT® II and confirmed by GC/MS.
Relative Specificity	High (e.g., >90-95%)	100%	For negative samples compared to Syva EMIT® II and confirmed by GC/MS.
Accuracy	High (e.g., >90-95%)	100%	Overall agreement with Syva EMIT® II and confirmed by GC/MS.
False Positives	Zero	Zero	Implied as no false positives were found.
False Negatives	Zero	Zero	Implied as no false negatives were found.

Note: The acceptance criteria are "implied" because the document states the results of the study (100% for all metrics) and then concludes that these results did not show any false positives or negatives, suggesting these perfect scores were sufficient for acceptance.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set:
- Clinical Trial: 298 samples.
- In-house testing: The exact number of samples for in-house testing is not specified, but it was conducted prior to the clinical trial. It states "samples documented to be positive by GC/MS," suggesting a subset of confirmed positive samples were used.
Data Provenance: The document does not explicitly state the country of origin. Given the company is Syntron Bioresearch, Inc. (Carlsbad, California) and the consultant is also US-based, it is highly probable the data is of US origin. The study was prospective in the sense of a clinical trial, but the confirmation by GC/MS would have been performed after the initial screening.

3. Number of Experts and Qualifications for Ground Truth of the Test Set

The document does not directly mention the use of "experts" to establish ground truth in the traditional sense of medical image or diagnosis interpretation. Instead, the ground truth was established by laboratory methods.

Number of Experts: Not applicable in this context.
Qualifications of Experts: Not applicable, as the ground truth was based on laboratory assays, not expert interpretation.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used when human interpretation is involved, especially in cases of disagreement. Since the ground truth for this device (an immunoassay for opiates) was established by laboratory comparison to a predicate device (Syva EMIT® II) and then confirmed by a gold standard method (GC/MS), an "adjudication method" as you've defined it is not applicable. Any disagreements between the QuikStrip and EMIT II would have been resolved by GC/MS.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that are interpreted by human readers (e.g., radiologists, pathologists) to assess how human performance is affected by the device (e.g., AI assistance). The QuikStrip test is a rapid, qualitative immunoassay that provides a direct result (visual color band), not requiring human interpretation in a way that would lend itself to an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire study described evaluates the QuikStrip device's performance (an "algorithm" in a broad sense, meaning the assay's biochemical mechanism) independently. Its results are compared to the predicate device (Syva EMIT® II) and a gold standard (GC/MS) without human-in-the-loop performance influencing the primary metrics of sensitivity, specificity, and accuracy. The device itself produces the qualitative result.

7. Type of Ground Truth Used

The ground truth for the test set was established using a hierarchical approach:

Primary Comparison: Against the Syva EMIT® II assay (a legally marketed predicate device).
Confirmation Standard (Gold Standard): All positive samples (by either screening method) were confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is considered the definitive gold standard for drug detection and quantification in forensic and clinical toxicology.

8. Sample Size for the Training Set

The document does not provide information regarding a distinct "training set" for the device. For a rapid immunoassay like the QuikStrip, the development process might involve initial R&D and optimization using various samples, but it's not typically structured with separate, formally defined "training," "validation," and "test" sets in the same way an AI/ML algorithm would be. The reported data relates to the final performance evaluation of the device.

9. How Ground Truth for the Training Set Was Established

As no distinct training set is identified, the method for establishing its ground truth is not mentioned in the provided text. If an implicit training was involved during product development, it would likely have relied on similar analytical methods (e.g., GC/MS or other established methods) to ensure the assay's reagents and design performed as intended during optimization.

Summary

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K972571

510k Submission for QuikStrip One Step Opiates Test Syntron Bioresearch, Inc.

AUG 2 0

Page 72 of 72

Revision A 6/18/97 Printed on 7/8/97

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 Opiates and its metabolites in a screening format.

The trade name of the device is QuikStrip One Step Opiates Test having a designated common name of Opiates 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 QuikStrip One Step Opiates 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® run at 300 ng/ml.

All positive samples by either screening method were confirmed by GC/MS. The testing performed by both the sponsor and the Clinical Trial site did not find any false positives or false negatives in the samples tested.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with a flowing, curved design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central image.

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, California 93065

AUG 20 1951

Re : K972571 Trade Name: QuikStrip One Step Opiate Assay Requlatory Class: II Product Code: DJG Dated: July 8, 1997 Received: July 10, 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, Druq, 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 requirement, as set forth in the Quality System Requlation (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 Reqister. 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 Requlations.

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Paqe 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4588. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if Known): Has Yet to be assigned

Device Name: Syntron's QuikStrip One Step Opiates 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)

Semore fa Montgomery
(Division Sign Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 972521

Perscription Use: _ C (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).