The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of Amphetamine in urine at a cutoff concentration of 300 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.

Device Description

The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Amphetamine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Amphetamine and its metabolite in urine at a cutoff concentration of 300 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 Amphetamine at the concentration 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

Here's a breakdown of the acceptance criteria and study details for the ACON AMP 300 One Step Amphetamine Test Strip and Test Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of predefined numerical targets for performance metrics. Instead, it presents the results of a clinical evaluation and "demonstrated substantial equivalency" to a predicate device and good agreement with GC/MS. The "acceptance" is implied by the FDA clearance based on these results.

Here's a table based on the demonstrated performance of the device compared to the predicate and GC/MS, which serves as the de facto "met acceptance criteria" based on the FDA's "substantial equivalency" finding.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (ACON AMP 300 One Step Amphetamine Test Strip)	Reported Device Performance (ACON AMP 300 One Step Amphetamine Test Device)
Vs. Predicate Device
Positive Agreement	High agreement (e.g., >95% with 95% CI)	>99% (97% - 99%)**	>99% (97% - 99%)**
Negative Agreement	High agreement (e.g., >95% with 95% CI)	>99% (98% - 99%)**	>99% (98% - 99%)**
Overall Agreement	High agreement (e.g., >95% with 95% CI)	>99% (99% - 99%)**	>99% (99% - 99%)**
Vs. GC/MS (Ground Truth)
Positive Agreement	High agreement for positive samples (e.g., >95% with 95% CI)	>99% (125/125) (97% - 99%)**	>99% (125/125) (97% - 99%)**
Negative Agreement	High agreement for negative samples (e.g., >95% with 95% CI)	99% (173/175) (96% - 98%)*	99% (173/175) (96% - 99%)*
Total Agreement	High overall agreement (e.g., >95% with 95% CI)	99% (298/300) (98%- 99%)*	99% (298/300) (98% - 99%)*

*Note: * Denotes 95% confidence interval. ** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval.

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

Sample Size for Test Set: 300 clinical urine specimens.
Data Provenance: The document refers to them as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, but the submission is to the FDA, suggesting samples relevant to the US market or regulatory context. The study is a "clinical evaluation," based on retrospectively collected "clinical urine specimens" compared against a predicate and GC/MS.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemical method, not human expert interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied to image-based diagnostic AI is not directly applicable here. The expertise lies in operating and interpreting GC/MS results, which is standard practice in toxicology labs.

4. Adjudication Method for the Test Set

The adjudication method involved comparing the results of the ACON AMP 300 tests (Strip and Device) against the results obtained from a FDA-cleared Amphetamine test (the predicate) and Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This indicates a direct comparison and quantitative analysis against established methods, rather than an adjudication process requiring multiple human readers to resolve discrepancies. GC/MS served as the definitive ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This study assesses the performance of a diagnostic device (an Amphetamine test) rather than an AI-assisted interpretation tool for human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable here. The device itself is the diagnostic tool.

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

Yes, the primary performance studies described are standalone. The ACON AMP 300 One Step Amphetamine Test Strip and Test Device are designed to be standalone diagnostic tools that provide a visual, qualitative result. The "clinical evaluation" compared the device's output directly against the predicate and GC/MS, without human interpretation of the device being the primary variable being measured or improved. The device itself provides the result.

7. The Type of Ground Truth Used

The primary and most definitive ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. The FDA-cleared Amphetamine test also served as a comparative reference.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is common for traditional in vitro diagnostic devices like immunoassay strips, where the "training" (development and calibration) typically occurs during the manufacturing and R&D phase using known standards and internal validation, rather than through a distinct "training set" of clinical data for a machine learning model. The clinical evaluation mentioned uses a "clinical urine specimens" as the test set for validation.

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

As no separate "training set" with ground truth establishment for a machine learning model is mentioned, this question is not directly applicable in the context of this traditional immunoassay device. The performance characteristics of the device were verified through analytical studies (sensitivity, specificity, cross-reactivity, interference, precision, read time flex, temperature flex, specimen storage and stability) (Page 4), which would have relied on precisely known concentrations of analytes and interferents, not a "ground truth" derived from clinical samples in the same way as a machine learning training set.

Summary

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510(k) SUMMARY 8.

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 104/822____

Submitter:

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

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

Date:

July 2, 2004

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® AMP 300 One Step Amphetamine Test Strip ACON® AMP 300 One Step Amphetamine Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Amphetamine in urine.

Regulation Name:

Amphetamine test system.

Product Code:

DKZ

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Classification Number:

21 CFR, 862.3100

Device Classification:

The Amphetamine test systems have been classified as Class II devices with moderate complexity. The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device are similar to another FDA-cleared device for the qualitative detection of Amphetamine 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 AMP 300 One Step Amphetamine Test Strip and ACON AMP 300 One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of Amphetamine in urine at a cutoff concentration of 300 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:

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 Amphetamine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

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Comparison to a Predicate Device:

A comparison of the features of the ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device versus a FDA-cleared Amphetamine test with 300 ng/mL Amphetamine cutoff is shown below:

Both tests are assays intended for the qualitative detection of Amphetamine 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 . Amphetamine 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 Amphetamine concentration of 300 ng/mL. .

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Amphetamine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON AMP 300 One Step Amphetamine Test Strip and ACON AMP 300 One Step Amphetamine Test Device with a FDA-cleared Amphetamine 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 AMP 300 One Step Amphetamine Test Strip versus a FDA-cleared AMP 300 Test:

Positive Agreement: 127 / 127 > 99% (97 % - 99%) ** Negative Agreement: 173 / 173 > 99% (98 % - 99%)** Overall Agreement: 300 / 300 > 99% (99 % - 99 %) ** * 95% confidence intervals

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.

ACON AMP 300 One Step Amphetamine Test Device versus a FDA-cleared AMP 300 Test:

Positive Agreement: 127 / 127 > 99% (97 % - 99%) ** Negative Agreement: 173 / 173 > 99% (98 % - 99%) ** Overall Agreement: 300 / 300 > 99% (99 % - 99 %) ** * 95% confidence intervals ** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.

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ACON AMP 300 One Step Amphetamine Test Strip versus data obtained with GC/MS at the cutoff concentration of 300 ng/mL:

		Specimen Cutoff Range by GC/MS Data
		Negative†	<-25% Cutoff	-25% to Cutoff	Cutoff to +25%	> +25% Cutoff	% Agreement
ACONAMP-300Test Strip	Positive	0	1	1	2	123	>99% (125/125)(97% - 99%)**
ACONAMP-300Test Strip	Negative	150	18	5	0	0	99% (173/175)(96% - 98%)*

ACON AMP 300 One Step Amphetamine Test Strip versus GC/MS.

Total agreement with GC/MS: 298/300 = 99% (98%- 99%)*

Denotes 95% confidence interval.

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval. + App. 10% negative specimen samples were also confirmed by GC/MS.

ACON AMP 300 One Step Amphetamine Test Device versus GC/MS.

		Specimen Cut off Range by GC/MS Data
		Negative†	<-25% Cutoff	-25% to Cutoff	Cutoff to +25%	>+25% Cutoff	% Agreement
ACONAMP- 300TestDevice	Positive	0	1	1	2	123	>99% (125/125)(97% - 99%)**
	Negative	150	18	5	0	0	99% (173/175)(96% - 99%)*

Total agreement with GC/MS: 298/300 = 99% (98% - 99%)*

Denotes 95% confidence interval.

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.

App. 10% negative specimen samples were also confirmed by GC/MS.

Performance Characteristics and Other information:

The performance characteristics of the ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine 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.

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Conclusion:

These clinical studies demonstrated substantial equivalency on performance among the ACON AMP 300 One Step Amphetamine Test Strip, the ACON AMP 300 One Step Amphetamine Test Device and a FDA-cleared Amphetamine test with the same Amphetamine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Amphetamine at a concentration of 300 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 U.S.A." arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing three wavy lines, which are meant to represent the human spirit and the department's mission to protect and promote the health and well-being of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K041822 Re:

Trade/Device Name: ACON AMP 300 One Step Amphetamine Test Strip ACON AMP 300 One Step Amphetamine Test Device Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: July 2, 2004 Received: July 6, 2004

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered processified 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). and Cosmetic (110.) that the device, subject to the general controls provisions of the Act. The r ou may, ateres provisions of the Act include requirements for annual registration, listing of general controlo proving 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 your device to such additional controls. Existing major regulations affecting your device it may oc sabject it bach acen 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 r toase be devilou and itermination that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I odotal statutes and sequirements, 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,

Jean M. Cooper MS, DVM.

Jean M. Cooper, MS, 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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Indications for Use

510(k) Number (if known): K041822

ACON AMP 300 One Step Amphetamine Test Strip Device Name:

ACON AMP 300 One Step Amphetamine Test Device

Indications For Use:

The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step The RCON AMIL 300 One 2007 id chromatographic immunoassays for the qualitative detection of Amphetamine levels in urine at a designated cutoff concentration of 300 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

This 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) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 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)

Alberts Gertz

Division Sign-ø

Office of In Vitro Diag Device Evaluation

510(k) K041822

Page 1 of __ 1 __

Regulation Number and Section

§ 862.3100 Amphetamine test system.

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