The Methadone assay is used for the qualitative analysis of methadone in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose.

The Methadone assay is calibrated with methadone and is specific for methadone.

The Methadone assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Description

Methadone is an in vitro diagnostic assay for the qualitative analysis of methadone in human urine. The assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

AI/ML Overview

Here's an analysis of the provided text regarding the Methadone assay, outlining the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial equivalence to predicate device (Emit® II Methadone assay on SYVA®-30R Analyzer)	Demonstrated by 100% agreement in method comparison.
Acceptable correlation with GC/MS (confirmatory method)	99% agreement with GC/MS.
Precision (Within-run and total at various control levels)	Total %CV for controls: range from 0.63% to 0.74%.
Qualitative analysis of methadone in human urine with a 300 ng/mL cutoff	Device performs qualitative analysis with a 300 ng/mL cutoff.
Limit of Detection (Sensitivity)	20 ng/mL

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

Test Set Sample Size: The document mentions "clinical specimens tested ranged from 231.0 to 40,190.0 ng/mL" for the GC/MS comparison, but the exact number of clinical specimens is not explicitly stated. For the comparison with the predicate device, it also does not explicitly state the number of samples used, only that there was 100% agreement.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

Number of Experts: Not applicable. The ground truth was established by laboratory methods, not expert human review.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by laboratory methods (predicate device and GC/MS), not by human adjudication of opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an AI-based image analysis or diagnostic assist tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the described performance (concordance with predicate and GC/MS, precision, limit of detection) represents the standalone performance of the Methadone assay as an algorithm/device, without human intervention in the result generation.

7. The Type of Ground Truth Used

Type of Ground Truth:
- Predicate Device Comparison: The Emit® II Methadone assay on the SYVA®-30R Analyzer served as a reference standard for establishing substantial equivalence.
- Confirmatory Method: Gas Chromatography/Mass Spectrometry (GC/MS) was used as the "gold standard" or confirmatory method to establish the accuracy of the device.

8. The Sample Size for the Training Set

Training Set Sample Size: This information is not provided in the document. The document describes performance studies, but not the development or training of the assay. For an enzyme immunoassay, there isn't typically a "training set" in the same sense as machine learning algorithms. The assay design and calibration are based on known chemical properties and concentrations of methadone.

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

Ground Truth for Training Set: This information is not provided and is not directly applicable in the context of a traditional enzyme immunoassay. The "ground truth" for calibrating such an assay would typically involve using precisely quantified standards of methadone.

Summary

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MAR 2 0 2002

K013001

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038

Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533

November 21, 2001 Date of Preparation of this Summary: Methadone Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Methadone Classification Number/Class: DJR/Class II

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: K013001.

Test Description:

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Substantial Equivalence:

The Methadone assay is substantially equivalent to the Emit® TI Methadone assay (K920751) on the SYVA®-30R Analyzer.

Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro immunoassays.
. Both assays can be used for the qualitative analysis of Methadone.
. Both assays yield similar results.
. Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.

Differences:

. There is a difference between the assay ranges (cutoff).
. The Methadone assay is qualitative. The Emit II Methadone assay is qualitative and semiquantitative.

Intended Use:

The Methadone assay is used for the qualitative analysis of methadone in human urine with a cuto[f of 300 ng/mL. For use in clinical laboratories.

The Methadone assay is calibrated with methadone and is specific for methadone.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Methadone assay method comparison yielded acceptable correlation with the Emit II Methadone assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Methadone assay method comparison yielded acceptable correlation with GC/MS. The concordance table shows 99% agreement with GCMS. The clinical specimens tested ranged from 231.0 to 40,190.0 ng/mL. Precision studies were conducted using the Methadone assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.72%, Cutoff Calibrator is 0.72%,

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Verifier II is 0.63%, - 25% Control of Cutoff Calibrator is 0.74%, and + 25% Control of Cutoff Calibrator is 0.70%. The Methadone assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Methadone assay is 20 ng/mL. These data demonstrate that the performance of the Methadone assay is substantially equivalent to the performance of the Emit II Methadone assay on the SYVA-30R Analyzer.

Conclusion:

The Methadone assay is substantially equivalent to the Emit II Methadone assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The text is black and the background is white.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 0 2002

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038

Re: K013001

Trade/Device Name: Methadone Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Simpson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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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510(k) Number (if known): K013001

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Methadone assay is calibrated with methadone and is specific for methadone.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
K013001

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).