The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose.

This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.

Device Description

The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Methamphetamine in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Methamphetamine and its metabolite in urine at a cutoff concentration of 500 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Methamphetamine at the concentration i below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

This document describes the acceptance criteria and study results for the ACON® mAMP-500 One Step Methamphetamine Test Strip and Test Device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through comparison to a predicate device and against a gold standard (GC/MS). The tables below summarize the performance for both the Test Strip and Test Device. Given that the acceptance criteria are not explicitly stated as numerical targets in the document beyond general agreement with a predicate and GC/MS, the "Target Performance" column reflects inferred expectations for high agreement.

ACON mAMP-500 One Step Methamphetamine Test Strip Performance

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance (95% CI)
Positive Agreement vs. FDA-cleared mAMP 500 Test	High agreement	99% (97% - 100%)
Negative Agreement vs. FDA-cleared mAMP 500 Test	High agreement	80% (73% - 85%)
Overall Agreement vs. FDA-cleared mAMP 500 Test	High agreement	87% (83% - 91%)
Positive Agreement vs. GC/MS	High agreement (especially for >+25% Cutoff)	100% (140/140) (97% - 100%)
Negative Agreement vs. GC/MS	High agreement (especially for Negative)	97% (153/160) (91% - 98%)
Total Agreement vs. GC/MS	High agreement	98% (95% - 99%)

ACON mAMP-500 One Step Methamphetamine Test Device Performance

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance (95% CI)
Positive Agreement vs. FDA-cleared mAMP 500 Test	High agreement	100% (97% - 100%)
Negative Agreement vs. FDA-cleared mAMP 500 Test	High agreement	82% (76% - 87%)
Overall Agreement vs. FDA-cleared mAMP 500 Test	High agreement	89% (84% - 92%)
Positive Agreement vs. GC/MS	High agreement (especially for >+25% Cutoff)	99% (139/140) (96% - 99%)
Negative Agreement vs. GC/MS	High agreement (especially for Negative)	98% (156/160) (94% - 99%)
Total Agreement vs. GC/MS	High agreement	98% (96% - 99%)

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

Sample Size: 300 clinical urine specimens.
Data Provenance: Clinical urine specimens. The country of origin is not specified, nor is whether the data was retrospective or prospective, though "clinical evaluation was conducted" implies prospective collection for the study. Approximately 10% of specimens contained methamphetamine concentration between -25% cutoff to +25% cutoff range, indicating a focus on the diagnostic gray zone.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is an analytical chemical method, not by human experts. Therefore, the concept of "number of experts" and their qualifications as typically applied to medical imaging or diagnostics read by humans does not directly apply here.

4. Adjudication Method for the Test Set

Not applicable as the ground truth was established by an objective analytical method (GC/MS), not by human interpretation or adjudication.

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 chromatographic immunoassay that provides a visual, qualitative end result, and does not involve AI or human readers interpreting complex data.

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

Yes, the performance data presented is for the device in its standalone capacity (algorithm only, as it's an immunoassay that produces a direct result), compared against a predicate device and GC/MS. The "human-in-the-loop" aspect is limited to reading a visual result (presence or absence of a colored line).

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an objective, highly specific, and sensitive analytical method considered the gold standard for confirming drug presence and concentration in toxicology.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. This is typical for simple immunoassay devices which are developed and validated, rather than "trained" in the machine learning sense. The clinical evaluation data (300 specimens) serves as the validation/test set for the device's performance.

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

As no specific "training set" is mentioned in the context of machine learning, this question is not applicable. The device's underlying immunoassay principles are based on established antibody-antigen reactions, not a data-driven training process. The accuracy of the device is assessed against GC/MS as the gold standard in a clinical evaluation.

Summary

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DEC 1. 2 2003

8. 510(k) SUMMARY

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 _ K 033299

Submitter:

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

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

Date:

October 7, 2003

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® mAMP-500 One Step Methamphetamine Test Strip ACON® mAMP-500 One Step Methamphetamine Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Methamphetamine in urine.

Regulation Name:

Methamphetamine test system.

Product Code:

LAF

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Classification Number:

21 CFR, 862.3610

Device Classification:

The Methamphetamine test systems have been classified as Class II devices with moderate complexity. The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are similar to another FDA-cleared device for the qualitative detection of Methamphetamine in urine specimens. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.

Intended Use:

The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of Methamphetamine in urine at a cutoff concentration of 500 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for healthcare professionals including professionals at point-of-care sites.

Description:

Comparison to a Predicate Device:

A comparison of the features of the ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared Methamphetamine test with 500 ng/mL Methamphetamine cutoff is shown below:

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Both tests are assays intended for the qualitative detection of Methamphetamine 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 immunoassay principles that rely on antigen/ antibody . interactions to indicate a positive or negative result.
Both tests have a cutoff Methamphetamine concentration of 500 ng/mL. .

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Methamphetamine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device with a FDA-cleared Methamphetamine test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:

ACON mAMP-500 One Step Methamphetamine Test Strip versus a FDA-cleared mAMP 500 Test:

Positive Agreement: 108 / 108 =>99% (97 % - 100 %) Negative Agreement: 153 / 192 = 80% (73 % = 85%) Overall Agreement: 261 / 300 = 87% (83 % - 91 %*) * 95% confidence intervals

ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared mAMP 500 Test:

Positive Agreement: 108 / 108= 100% (97 % - 100 %) Negative Agreement: 158 / 192= 82% (76 % - 87 %) Overall Agreement: 266 / 300 = 89% (84 % - 92 %*) * 95% confidence intervals

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ACON mAMP-500 One Step Methamphetamine Test Strip versus data obtained with GC/MS at the cutoff concentration of 500 ng/mL:

		Specimen Cutoff Range by GC/MS Data				% Agreement withGC/MS Data
		Negative	< -25%Cutoff	-25% toCutoff	Cutoff to+25%	> +25%Cutoff
ACONmAMP500 TestStrip	Positive	0	0	7	8	132	100% (140/140)(97% - 100%)*
	Negative	150	0	3	0	0	97% (153/160)(91% - 98%)*

ACON mAMP-500 One Step Methamphetamine Test Strip versus GC/MS

Total agreement with GC/MS : 293/300 = 98% (95%- 99%)* * Denotes 95% confidence intervals.

ACON mAMP-500 One Step Methamphetamine Test Device versus GC/MS

		Specimen Cut off Range by GC/MS Data				% Agreement with GC/MS Data
		Negative	<-25% Cutoff	-25% to Cutoff	Cutoff to +25%	>+25% Cutoff
ACONmAMP-500Test Device	Positive	0	0	4	8	131	99% (139/140)(96% - 99%)*
ACONmAMP-500Test Device	Negative	150	0	6	0	1	98% (156/160)(94% - 99%)*

Total agreement with GC/MS : 295/300 = 98% (96% - 99%)* * Denotes 95% confidence interval.

Performance Characteristics and Other information:

The performance characteristics of ACON mAMP-500 One Step Methamphetamine Test Strip, ACON mAMP-500 One Step Methamphetamine Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.

Conclusion:

These clinical studies demonstrated substantial equivalency on performance between the ACON mAMP-500 One Step Methamphetamine Test Strip, ACON mAMP-500 One Step Methamphetamine Test Device and a FDA-cleared Methamphetamine test with the same Methamphetamine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Methamphetamine at a concentration of 500 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, represented by three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2003

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

Re: K033299

Trade/Device Name: ACON mAMP-500 One Step Methamphetamine Test Strip ACON mAMP-500 One Step Methamphetamine Test Device Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: October 7, 2003 Received: October 14, 2003

Dear Dr. Tung:

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 (301) 594-3084. 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 (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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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11. INDICATIONS FOR USE

510(k) Number: K033299

Device Name: ACON mAMP-500 One Step Methamphetamine Test Strip

ACON mAMP-500 One Step Methamphetamine Test Device

Indications for Use:

Albert Sarr

Joan

(opper

Division Sign-Off for

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033299

Prescription USE ✓

Over the Counter

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).