The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.

The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.

The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.

Device Description

Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Quest Diagnostics Methamphetamine Micro-Plate EIA. It describes the device, its intended use, and states that it is "substantially equivalent" to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study data that would typically be presented to prove a device meets those criteria.

Generally, for a qualitative diagnostic device like this, acceptance criteria would involve sensitivity and specificity targets, often compared against a gold standard method. The study detailed would describe how these metrics were evaluated.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the given text. The document states that "Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA." However, specific numerical targets for these performance metrics (e.g., "sensitivity > 95%") and the exact reported performance numbers are absent.

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

This information is not explicitly provided in the given text. The document mentions "Results obtained from patient specimens," but does not specify the number of specimens, the country of origin, or if the data was retrospective or prospective.

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

This information is not provided in the given text. For a device like this, the "ground truth" for methamphetamines is typically established by gas chromatography/mass spectroscopy (GC/MS), not by expert readers.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. As mentioned above, ground truth for methamphetamine detection is established by a definitive chemical method (GC/MS), not by human adjudication of images or other subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers interpret data. For a qualitative immunoassay for drug detection, it's not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Yes, the studies described are inherently "standalone" in the sense that they evaluate the performance of the immunoassay itself in detecting methamphetamine. The device provides a qualitative result based on chemical reactions, not human interpretation. The "Comparison Performance Data" and "Results obtained from patient specimens" refer to the intrinsic performance of the assay.

7. The Type of Ground Truth Used:

The ground truth assumed for validating drug screening tests like this is typically a confirmatory chemical method, specifically Gas Chromatography/Mass Spectroscopy (GC/MS). This is explicitly stated in the "Indications for Use Statement": "To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method."

8. The Sample Size for the Training Set:

This information is not provided in the given text. As a traditional immunoassay, there wouldn't be a "training set" in the machine learning sense. The device is developed based on known chemical reactions and antibody-antigen binding principles. The "performance characteristic studies" would involve various types of samples to characterize the device, but not a "training set" for an algorithm.

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

This information is not applicable. As there is no "training set" in the machine learning context for this type of device, the concept of establishing ground truth for it doesn't apply. Device development involves biochemical engineering and validation against known standards and reference methods (like GC/MS).

In summary, the provided document indicates a determination of "substantial equivalence" based on performance characteristics and patient specimen results being in "substantial agreement" with a predicate device. However, it lacks the detailed quantitative acceptance criteria and the specific study data that would demonstrate how these criteria were met for standalone performance. The focus is on comparing it to an existing, legally marketed device rather than detailing de novo performance against a strict set of predefined acceptance criteria for sensitivity, specificity, etc. This is characteristic of a 510(k) submission where substantial equivalence is the primary pathway to market.

Summary

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510(k) Summary----------------------------------------------------------------------------------------------------------------------------------------------------------------

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Apr. 9th, 2008 Date of Summary:

Correspondent:

Name:
Address:
Phone Number:
Fax Number:
E-mail

Liuming Yu 10101 Renner Boulevard, Lenexa, Kansas 66210-9752 913-895-2308 913-577-1429 liuming.yu@labone.com

Product Name:

Common Name: Quest Diagnostics Methamphetamine Micro-Plate ElA Trade Name: Quest Diagnostics Methamphetamine Micro-Plate EIA Classification Number: 862.3610

Predicate Device:

Orasure Methamphetamine Intercept® Micro-Plate EIA

Product Description:

Intended Use:

Quest Diagnostics Methamphetamine Micro-Plate EIA is a competitive micro-immunoassay for the qualitative detection of Methamphetamines in oral fluid collected with the Orasure™ Oral Specimen Collection Device.

Comparison:

When used to qualitatively detect Methamphetamine in oral fluid specimens collected with the Orasure™ Oral Specimen Collection Device, the Quest Diagnostics Methamphetamine Micro-Plate EIA vields results in substantial agreement with the predicate device.

Comparison Performance Data:

Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA.

Results obtained from patient specimens showed that the results from the new assay are substantially equivalent to those obtained from the predicate device.

Conclusion:

The Quest Diagnostics Methamphetamine Micro-Plate EIA is substantially equivalent to the Orasure Methamphetamine Intercept® Micro-Plate EIA and can be used to qualitatively screen oral specimens collected with the Orasure™ Oral Specimen Collection Device.

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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 its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Quest Diagnostics, Inc. c/o Liuming Yu Associate Director 10101 Renner Blvd. Lenexa, K.S 66219-9752

JUN 2 5 2008

Re: K080381/S001 Trade Name: Quest Diagnostics Methamphetamine Micro-Plate EIA Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Micro-Plate EIA Regulatory Class: Class II Product Codes: LAF Dated: June 13, 2008 Received: June 17, 2008

Dear Liuming Yu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number (if known) K 080381

Device Name: Quest Diagnostics Methamphetamine Micro-Plate EIA

Indications for Use

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

Page 1 of

Office of In Vitro Diagnostic Device Frauation and Safety

K080381

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).