The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1,000 ng/mL. It is intended for professional and point of care use.

Device Description

The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are competitive binding, lateral-flow immunochromatographic assays for the qualitative detection of methamphetamine in a urine specimen. The test utilizes a mouse monoclonal antibody to selectively detect elevated levels of methamphetamine in urine at a cut-off concentration of 1,000 ng/mL. These tests can be performed and interpreted without the use of an instrument. A drug-positive urine specimen will not generate a colored line in the test region, while a negative urine specimen will generate a colored line in the test region. To serve as procedural control, a colored line will always appear at the control region indicating that a proper volume of specimen has been applied and membrane wicking has occurred. When performing these ACON mAMP tests, one colored line indicates a positive result and two colored lines indicate a negative result; and the test includes a positive results when there is no colored line in the control region.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ACON mAMP One Step Methamphetamine Test Strip and Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct targets in the document. However, the study aims to demonstrate substantial equivalence to a predicate device and agreement with GC/MS analysis. Therefore, we can infer the performance metrics from the reported results.

Metric (Inferred Acceptance Criteria)	ACON mAMP One Step Methamphetamine Test Strip	ACON mAMP One Step Methamphetamine Test Device
Compared to LifeSign Status DS™ MET One-Step Methamphetamine Test
Positive Agreement (for substantial equivalence)	98% (94% - 100% 95% CI)	99% (96% - 100% 95% CI)
Negative Agreement (for substantial equivalence)	100% (98% - 100% 95% CI)	100% (98% - 100% 95% CI)
Overall Agreement (for substantial equivalence)	99% (97% - 100% 95% CI)	100% (98% - 100% 95% CI)
Compared to GC/MS Analysis Data
Positive agreement with GC/MS	99% (96% - 100% 95% CI)	99% (96% - 100% 95% CI)
Negative agreement with GC/MS	94% (89% - 97% 95% CI)	93% (86% - 96% 95% CI)
Total agreement with GC/MS	96% (94% - 100% 95% CI)	96% (93% - 98% 95% CI)
Positive Predictive Value (+)	93% (88% - 97% 95% CI)	92% (86% - 96% 95% CI)
Negative Predictive Value (-)	99% (96% - 100% 95% CI)	99% (96% - 100% 95% CI)
Cut-off Concentration	1,000 ng/mL	1,000 ng/mL

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

Sample Size for Test Set: 300 urine specimens.
Data Provenance: Not explicitly stated, but clinical evaluations are typically conducted with prospective or retrospectively collected real-world samples. The document does not specify the country of origin.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The reference standard, Gas Chromatography/Mass Spectrometry (GC/MS), is a definitive analytical method, so a separate adjudication process for subjective expert interpretation would likely not be necessary.

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

No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test for methamphetamine detection in urine, primarily relying on immunoassay technology for a qualitative result, not an AI-assisted diagnostic tool that would involve human readers interpreting complex images or data with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The "ACON mAMP One Step Methamphetamine Test Strip" and "ACON mAMP One Step Methamphetamine Test Device" are themselves the standalone "algorithm" (immunochromatographic assay). Their performance was compared directly to Gas Chromatography/Mass Spectrometry (GC/MS) analysis data, which represents a standalone evaluation of the device's accuracy without a human "interpretation" component beyond reading the visible lines.

7. The Type of Ground Truth Used

The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis results. GC/MS is a highly accurate and definitive analytical method for identifying and quantifying substances in a sample, making it a reliable "gold standard" for drug detection.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. For an immunochromatographic test, the development process typically involves optimizing reagents and conditions rather than training a machine learning model on a distinct dataset. The "clinical evaluation" described is the test set for performance assessment.

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

Since a distinct training set (in the machine learning sense) is not mentioned for this type of device, the concept of establishing ground truth for a training set is not applicable here. The device's underlying principles are based on antigen-antibody interactions, and its "training" or optimization would involve laboratory development and calibration, using known concentrations of methamphetamine and reference standards, rather than a data-driven ground truth establishment for a training set.

Summary

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JUL 3 1 2001

SUMMARY OF 510 K SAFETY AND EFFECTIVENESS

This summary of 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: K011672

Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel .: 858-535-2030 X1072 Fax: 858-535-2038

Date:

July 12, 2001

Contact Person:

Edward Tung, Ph.D. Director of Regulatory Affairs

Product Names:

ACON mAMP One Step Methamphetamine Test Strip

ACON mAMP One Step Methamphetamine Test Device

Common Name:

Immunochromatographic test for the qualitative detection of methamphetamine in urine.

Device Classification:

ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are similar to other FDA-cleared devices for the qualitative detection of methamphetamine in urine specimens. These tests are used for providing only a preliminary analytical result (21 CFR 862.3610). Methamphetamine test systems have been classified as Class II devices with moderate complexity. These methamphetamine tests bear Product Code LAF.

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Classification Name:

Methamphetamine test system

Intended Use:

The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One The ACON mAMP One Step Methanphenanine Fest provinci immunoassays for the Step Methamphetamine Fest Dorrecamine in human urine at a cut-off concentration qualifative detection of misunded for professional and point-of-care use.

Description:

The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One The ACON MANI One Diep Mothanipers are competitive binding, lateral-flow Step Memailiphic assays for the qualitative detection of methamphetamine in a iffinunocificiliatographic assays for the quainless fantigen-antibody immunochemistry. It utilizes a mouse monoclonal antibody to selectively detect elevated levels of It unlizes a mouse monoconar unroover unroover tration of 1,000 ng/mL. These tests can be performed and interpreted without the use of an instrument.

A drug-positive urine specimen will not generate a colored line in the test region, A drug-positive urine specimen will generate a colored line in the test region. To while a negative unine speemien will generate always appear at the control region serve as procedural control, a colorecimen has been applied and membrane wicking indicating that a proper volume erforming these ACON mAMP tests, one colored line indicates a positive result and two colored lines indicate a negative result; and the test includes a positive results when there is no colored line in the control region.

Predicate Device:

LifeSign Status DS™ MET One-Step Methamphetamine Test

510(k) Number: K961249

Distributor: LifeSign, LLC 71 Veronica Avenue Somerset, New Jersey 08873

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Comparison to a Predicate Device:

A comparison of the features of ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device to LifeSign Status DS™ MET One-Step Methamphetamine Test is listed below.

Both tests are assays intended for the qualitative detection of methamphetamine . and its derivatives in urine samples.
Both tests are intended as a screening method that provides a preliminary . analytical test result.
Both tests are immunochromatographic, lateral-flow assays for the rapid detection . of methamphetamine with a visual, qualitative end result.
Both tests utilize the same basic immunochemistry principles that rely on � antigen/antibody interactions to indicate a positive or negative result.
� Both tests have a methamphetamine cut-off concentration of 1.000 ng/mL for the detection of methamphetamine in urine specimens.

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 300 urine specimens. This evaluation compared the study results obtained with ACON mAMP One Step Methamphetamine Test Strip, ACON mAMP One Step Methamphetamine Test Device, and LifeSign Status DS MET One-Step Methamphetamine Test to the customary Gas Chromatography/Mass Spectrometry analysis results. The data from this study vielded the following results:

ACON mAMP One Step Methamphetamine Test Strip compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:

Positive Agreement: 145 / 148 = 98% (94% - 100%) Negative Agreement: 152 / 152 = 100% (98% - 100%) Overall Agreement: 297 / 300 = 99% (97% - 100%*)

95% confidence intervals

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ACON mAMP One Step Methamphetamine Test Device compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:

Positive Agreement: 147 / 148 = 99% (96% - 100%) Negative Agreement: 152 / 152 = 100% (98% - 100%) Overall Agreement: 299 / 300 = 100% (98% - 100%*)

95% confidence intervals

ACON mAMP One Step Methamphetamine Test Strip compared to GC/MS analysis data

Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%) Negative agreement with GC/MS: 154 / 164 = 94% (89% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 100%*)

Positive Predictive Value (+): 135 / 145 = 93% (88% - 97%) Negative Predictive Value (-): 153 / 154 = 99% (96% - 100%)

95% confidence intervals

ACON mAMP One Step Methamphetamine Test Device compared to GC/MS analysis data:

Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%) Negative agreement with GC/MS: 152 / 164 = 93% (86% - 96%) Total agreement with GC/MS: 287 / 300 = 96% (93% - 98%*)

Positive Predictive Value (+): 135 / 147 = 92% (86% - 96%) Negative Predictive Value (-): 152 / 153 = 99% (96% - 100%)

95% confidence intervals

Conclusion:

These study results have demonstrated ACON mAMP One Step Methamphetamine Test Strip and Test Device are substantially equivalent to LifeSign Status DS™ MET One-Step Methamphetamine Test. It has also been demonstrated that these tests are safe and effective in detecting urine methamphetamine at a concentration of 1,000 ng/mL. They are suitable for professional and point-of-care use.

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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress.

JUL 3 1 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121

Re: 510(k) Number: K011672 Trade/Device Name: ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device Regulation Number: 862.3610 Regulatory Class: II Product Code: LAF Dated: May 18, 2001 Received: May 30 , 2001

Dear Dr. Tung:

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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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 notheation. The I Dri imating of castion 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 CFF Part 801 and if you desire spoonly acrise to jiggnostic devices), please contact the Office of Compliance at additionally 607.10 for in the sur questions on the promotion and advertising of your device, (301) 594-4588. Rudinonally) for quest at (301) 594-4639. Also, please note the regulation prease conact the Orneo or Sompilation (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsiblemate and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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10. INDICATIONS FOR USE

KO11672 510(k) Number: ACON mAMP One Step Methamphetamine Test Strip Device Name: ACON mAMP One Step Methamphetamine Test Device ACON mAMP One Step Methamphetamine Test Strip and ACON Indications for Use: mAMP One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1,000 ng/mL. It is intended for professional and point of care use.

Jean Copy

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K011672

(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1/ (Per 21 CFR 801.109)

Over-The-Counter Use

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).