The ACON OPI II One Step Opiate Test Strip or the ACON OPI II One Step Opiate Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of opiates in human urine at a cut-off concentration of 2,000 ng/mL. It is a prescription use device intended for healthcare professionals including those at the 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) 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

The ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiate 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 Opiate and its metabolite in urine at a cutoff concentration of 2,000 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 Opiate 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 the study details for the ACON® OPI II One Step Opiate Test devices, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (implied by study)	Acceptance Criterion (implied)	Reported Device Performance (ACON OPI II One Step Opiate Test Strip & Device)
Accuracy (Comparison to FDA-cleared Opiate Test Device)	Positive Agreement	High (e.g., >95%)	99% (96% - 99% 95% CI)
	Negative Agreement	High (e.g., >95%)	>99% (98% - 99% 97.5% CI)
	Overall Agreement	High (e.g., >95%)	>99% (98% - 99% 95% CI)
Accuracy (Comparison to GC/MS at Cutoff)	Positive Agreement (for OPI II Test Strip)	High (e.g., >95%)	98% (95% - 99% 95% CI)
	Negative Agreement (for OPI II Test Strip)	High (e.g., >95%)	97% (93% - 99% 95% CI)
	Positive Agreement (for OPI II Test Device)	High (e.g., >95%)	98% (95% - 99% 95% CI)
	Negative Agreement (for OPI II Test Device)	High (e.g., >95%)	97% (93% - 99% 95% CI)
Other Performance Characteristics	Analytical sensitivity	Satisfactory	Verified
	Specificity and cross reactivity	Satisfactory	Verified
	Interference studies	Satisfactory	Verified
	Precision study	Satisfactory	Verified
	Read time flex study	Satisfactory	Verified
	Temperature flex study	Satisfactory	Verified
	Specimen storage and stability study	Satisfactory	Verified

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 300 clinical urine specimens.
- Data Provenance: Clinical urine specimens. The document doesn't explicitly state the country of origin, but it references "clinical evaluation" and "clinical urine specimens," suggesting real-world samples. It is retrospective as it refers to a "clinical evaluation," implying the samples were collected prior to the evaluation.
- Special Note: Approximately 10% of the specimens contained Opiate concentrations falling between -25% cutoff to +25% cutoff range, which is critical for assessing performance near the clinical decision point.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth from the FDA-cleared predicate device.
- For the GC/MS analysis (which serves as a highly definitive ground truth), it is implied that standard laboratory procedures were followed by qualified personnel, but no specific number or qualifications are provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe a specific adjudication method beyond comparing the device results to a predicate device and to GC/MS analysis. The "ground truth" for the GC/MS comparison is the GC/MS result itself, which is a definitive chemical analysis rather than an expert consensus process that would typically require adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or complex data with and without AI assistance. The test results are visual and qualitative, read directly from the test strip/device.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, the performance presented is standalone. This device is a manual, qualitative immunoassay. The "algorithm" is the biochemical reaction and visual readout on the test strip/device, and the performance metrics directly reflect its ability to detect opiates in urine without human interpretation beyond observing the presence or absence of a line.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primary Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is a highly definitive analytical chemical method for drug detection and quantification.
- Secondary Comparison: An FDA-cleared Opiate test device, serving as a predicate for comparison.
The sample size for the training set:
- The document does not explicitly state a training set size. This device is an immunoassay, not a machine learning or AI-based device that typically requires a distinct "training set" in the computational sense. Its "training" is inherent in its chemical design and manufacturing process. The 300 clinical urine specimens are used for "clinical evaluation" (testing), not for training an algorithm.
How the ground truth for the training set was established:
- As noted above, there is no explicit "training set" in the context of machine learning. The device's inherent design and analytical validation studies (analytical sensitivity, specificity, interference, precision, etc.) establish its performance characteristics. The 300 clinical samples were used for validation/testing, with GC/MS as the ground truth reference.

Summary

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MAY - 3 2004

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.

K040274 The Assigned 510(k) number is __

Submitter:

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

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

Date:

February 2, 2004

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® OPI II One Step Opiate Test Strip ACON® OPI II One Step Opiate Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Opiate in urine.

Regulation Name:

Opiates test system.

Product Code:

DJG

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Classification Number:

21 CFR, 862.3650

Device Classification:

The Opiate test systems have been classified as Class II devices with moderate complexity. The ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are similar to another FDA-cleared device for the qualitative detection of Opiate 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® OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiate in urine at a cutoff concentration of 2,000 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 OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device versus a FDA-cleared Opiate Test Device with 2,000 ng/mL Opiate cutoff is shown below:

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Both tests are assays intended for the qualitative detection of Opiate 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 Opiate . 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 Opiate concentration of 2,000 ng/mL. �

Safety and Effectiveness Data:

Accuracy

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

A CON OPI II One Step Opiate Test Strip versus FDA-cleared Opiate Test Device:

Positive Agreement: 131 / 132 = 99% (96 % - 99 %) Negative Agreement: 168 / 168 > 99% (98 % - 99 % **) Overall Agreement: 299 / 300 > 99% (98 % - 99 %) * 95% confidence intervals

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

ACON OPI II One Step Opiate Test Device versus FDA-cleared Opiate Test Device :

Positive Agreement: 131 / 132 = 99% (96 % - 99 %) Negative Agreement: 168 / 168 > 99% (98 % - 99 % **) Overall Agreement: 299 / 300 > 99% (98 % - 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 OPI II One Step Opiate Test Strip versus data obtained with GC/MS at the cutoff concentration of 2,000 ng/mL:

		Specimen Cutoff Range by GC/MS Data					% Agreement with GC/MS Data
		Negative	< -25% Cutoff	-25% to Cutoff	Cutoff to +25%	> +25% Cutoff
ACONOPI IITestStrip	Positive	0	0	2	20	109	98%(95% - 99%)*
ACONOPI IITestStrip	Negative	150	0	14	3	2	97%(93% - 99%)*

Denotes 95% Confidence Interval.

ACON OPI II One Step Opiate Test Device versus data obtained with GC/MS at the cutoff concentration of 2,000 ng/mL

		Specimen Cutoff Range by GC/MS Data				% Agreement with GC/MS Data
		Negative	< -25% Cutoff	-25% to Cutoff	Cutoff to > +25% Cutoff
ACONOPI IITestStrip	Positive	0	0	2	20	109	98%(95% - 99%)*
	Negative	150	0	14	3	2	97%(93% - 99%)*

Performance Characteristics and Other information:

The performance characteristics of ACON OPI II One Step Opiate Test Strip, ACON OPI II One Step Opiate 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 OPI II One Step Opiate Test Strip, ACON OPI II One Step Opiate Test Device and a FDA-cleared Opiate Test Device with the same Opiate cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Opiate at a concentration of 2,000 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 Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 3 2004

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

Re: K040274

Trade/Device Name: ACON OPI II One Step Opiate Test Strip ACON OPI II One Step Opiate Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test System Regulatory Class: Class II Product Code: DJG Dated: February 4, 2004 Received: February 5, 2004

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. Iisting 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 vours.

Jean M. Cooper, MS, DVM.
MS, DVM.

Yean 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:

K040274

Device Name:

ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device

Indications for Use:

The ACON OPI II One Step Opiate Test Strip or the ACON OPI II One Step Opiate Test The FCON OFFIC one chromatographic immunoassay for the qualitative detection of Dovice is a lacerar now ext a cut-off concentration of 2,000 ng/mL. It is a prescription oplaces in numan anne a battern > professionals including those at the point of care sites.

This assay provides only a preliminary analytical test result. A more specific alternate Themical 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Division Sign-Off

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagne Device Evaluation an

510(k) K040274

Page 1 of 1

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).