The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. They are intended for the healthcare professional use.

Device Description

The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiates in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. 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 Opiates at the concentration wills a logan of level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will 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 an analysis of the provided text regarding the ACON MOP One Step Opiate Test, focusing on acceptance criteria and the supporting study:

The document describes the ACON MOP One Step Opiate Test Strip and Device, which are rapid chromatographic immunoassays for the qualitative detection of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine.

1. Table of Acceptance Criteria and Reported Device Performance

The specific acceptance criteria (e.g., minimum percentage agreement) are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate "substantial equivalency" to a predicate device and "safe and effective" detection. Therefore, 100% positive agreement and high overall agreement with the predicate and GC/MS can be considered the de-facto performance goals.

Metric (Comparison to Predicate)	ACON MOP Test Strip Performance	ACON MOP Test Device Performance
Positive Agreement (vs. Predicate)	100% (98% - 100%*)	100% (98% - 100%*)
Negative Agreement (vs. Predicate)	100% (98% - 100%*)	100% (98% - 100%*)
Overall Agreement (vs. Predicate)	100% (98% - 100%*)	100% (98% - 100%*)

Metric (Comparison to GC/MS)	ACON MOP Test Strip Performance	ACON MOP Test Device Performance
Positive Agreement (vs. GC/MS)	100% (97% - 100%*)	100% (97% - 100%*)
Negative Agreement (vs. GC/MS)	94% (89% - 97%*)	94% (89% - 97%*)
Overall Agreement (vs. GC/MS)	97% (94% - 98%*)	97% (94% - 98%*)
** 95% Confidence Intervals

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

Sample Size: 300 clinical urine specimens.
- 10% of these samples had Opiate concentrations in the -25% cut-off to +25% cut-off range (i.e., near the decision point).
Data Provenance: The data is described as "clinical urine specimens," implying prospective collection from clinical settings. The country of origin is not specified, but the submitter is based in San Diego, California, USA, suggesting the data is likely from the United States. It is a retrospective clinical evaluation of previously collected samples.

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

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth when comparing to the predicate device. However, for the comparison against GC/MS, the GC/MS result itself serves as the objective ground truth, which does not typically involve human expert interpretation in the same way as, for example, image interpretation. The GC/MS analysis would be performed by trained laboratory technicians/scientists, but they are not referred to as "experts" for ground truth establishment in this context.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. For the comparison against the predicate, it implies a direct comparison of results. For the comparison against GC/MS, the GC/MS result is considered the definitive truth, so adjudication is not applicable in the traditional sense.

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 MRMC comparative effectiveness study was done. This device is a standalone immunoassay, not an AI-assisted diagnostic tool that would be used by human readers whose performance could be improved with assistance.

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

Yes, a standalone study was done. The performance metrics presented (Positive Agreement, Negative Agreement, Overall Agreement) represent the performance of the ACON MOP one-step tests as standalone devices, with their results being compared against both a predicate device and GC/MS. The test delivers a visual, qualitative end result without requiring external interpretation by a machine or complex algorithm that would involve human-in-the-loop processing for the initial reading.

7. The Type of Ground Truth Used

Two types of ground truth were used for the test set:

Results from the Screener Opiate Test Drugscreen™ DIP Opiate Test (the predicate device).
Data from Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the gold standard for confirmatory drug testing.

8. The Sample Size for the Training Set

The document does not mention a separate training set. This is typical for simple immunoassay devices that rely on chemical reactivity rather than machine learning algorithms that require a distinct training phase. The study described is a clinical validation study rather than a model development and training study.

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

Since no training set is described for this type of device, this question is not applicable. The device's underlying principle is antigen-antibody immunochemistry, which does not involve a "training" phase for an algorithm.

Summary

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DEC 1 82001

SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 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 K-013380.

Submitter:

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

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

Date: October 5, 2001

Contact Person: Edward Tung, Ph.D.

Product Names:

ACON® MOP One Step Opiate Test Strip ACON® MOP One Step Opiate Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Opiates in urine

Device Classification:

The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are similar to other FDA-cleared devices for the qualitative detection of Opiates in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3650). These test systems have been classified as Class II devices with moderate complexity. Product code DJG has been assigned for these Opiate test systems.

Classification Name:

Opiate test system

Intended Use:

The ACON® MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. They are intended for the healthcare professional use.

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Description:

Predicate Device:

Screener Opiate Test Drugscreen™ DIP Opiate Test 510(k) Number: K000273

Comparison to a Predicate Device:

A comparison of the features of the ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device versus the Screener Opiate Test Drugscreen™ DIP Opiate Test is shown below:
Both tests are assays intended for the qualitative detection of Opiates 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 . Opiates 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 cut-off for morphine concentration of 300 ng/mL. .

Safety and Effectiveness Data:

Accuracy:

A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with Opiate concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® MOP One Step Opiate Test Strip and Test Device with Screener Opiate Test Drugscreen™ DIP Opiate Test; as well as against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:

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ACON MOP One Step Opiate Test Strip versus the Screener Opiate Test Drugscreen™ DIP Opiate Test:

Positive Agreement: 150 / 150 = 100% (98% - 100%) Negative Agreement: 150 / 150 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (98% - 100%*)

95% Confidence Intervals

ACON MOP One Step Opiate Test Device versus Screener Opiate Test Drugscreen™ DIP Opiate Test:

Positive Agreement: 150 / 150 = 100% (98% - 100%) Negative Agreement: 150 / 150 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (98% - 100%*)

95% Confidence Intervals

ACON MOP One Step Opiate Test Strip versus GC/MS at the cut-off of 300 ng/ml:

Positive Agreement: 141 / 141 = 100% (97% - 100%) Negative Agreement: 150 / 159 = 94% (89% - 97%) Overall Agreement: 291 / 300 = 97% (94% - 98%*)

95% confidence intervals

ACON MOP One Step Opiate Test Device versus GC/MS at the cut-off of 300 ng/ml:

Positive Agreement: 141 / 141 = 100% (97% - 100%) Negative Agreement: 150 / 159 = 94% (89% - 97%) Overall Agreement: 291 / 300 = 97% (94% - 98%*)

95% confidence intervals

Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON MOP One Step Opiate Test Strip, ACON MOP One Step Opiate Test Device and Screener Opiate Test Drugscreen™ DIP Opiate Test, which has already being marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Opiates at a concentration of 300 ng/mL. They are intended for healthcare professionals' The POL study demonstrated that these tests are also suitable for healthcare use. professionals at point-of-care site use.

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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC 1 8 2001

Re: K013380

Trade/Device Name: ACON® MOP One Step Opiate Test Strip and ACON® MOP One Step Opiate Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: October 11, 2001 Received: October 12, 2001

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 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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INDICATIONS FOR USE 10.

510(k) Number:

Kor3380

Device Name: ACON® MOP One Step Opiate Test Strip

ACON® MOP One Step Opiate Test Device

Indications for Use:

The ACON MOP One Step Opiate Test Strip and ACON MOP The ACON MOT One Diop Opice are rapid chromatographic One Step Oplate Test Totalitative detection of Opiate in human Infinunoassays for the qualitation of 300 ng/mL. They are intended for healthcare professional use.

Thomas L. Darts for Jean Cooper
10/16/2023

ion Sigr (Division Sign-On)
Division of Clinical Laboratory Devices KO13380 510(k) Number

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ Or over-the-counter Use _

(Per 21 CFR 801.109)

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).