The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

Device Description

The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone 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 Oxycodone and its metabolite in urine at a cutoff concentration of 100 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 Oxycodone 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

The core of the study is a comparison of the ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device against a predicate FDA-cleared Oxycodone test and GC/MS analysis. The acceptance criteria aren't explicitly stated as numerical targets in the provided text, but rather implied through "substantial equivalency" to a predicate device and satisfactory performance against GC/MS. Based on the presented data, the implied acceptance criteria would likely be high agreement rates (e.g., >95% for positive and negative agreement).

Acceptance Criteria (Implied)	ACON® OXY One Step Oxycodone Test Strip Performance (vs. FDA-cleared test)	ACON® OXY One Step Oxycodone Test Device Performance (vs. FDA-cleared test)	ACON® OXY One Step Oxycodone Test Strip Performance (vs. GC/MS)	ACON® OXY One Step Oxycodone Test Device Performance (vs. GC/MS)
High Positive Agreement	97% (93% - 99% CI)	97% (93% - 99% CI)	96% (92% - 98% CI) (for positive samples by test)	96% (92% - 98% CI) (for positive samples by test)
High Negative Agreement	100% (98% - 100% CI)	100% (98% - 100% CI)	98% (95% - 99% CI) (for negative samples by test)	98% (95% - 99% CI) (for negative samples by test)
High Overall Agreement	99% (97% - 99% CI)	99% (97% - 99% CI)	Not explicitly calculated, but implied by individual agreements.	Not explicitly calculated, but implied by individual agreements.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 300 clinical urine specimens.
- Data Provenance: Clinical urine specimens are mentioned, implying human samples. The document does not specify the country of origin, nor whether the samples were retrospective or prospective, but clinical evaluation often implies prospective collection or representative retrospective collection for a device submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for comparison was established primarily by Gas Chromatography/Mass Spectrometry (GC/MS) analysis and a FDA-cleared Oxycodone test. The document does not mention the use of human experts to establish the ground truth in the traditional sense, as these are lab-based analytical methods.
Adjudication method for the test set:
- No adjudication method is described. The comparison is directly between the investigational devices and reference methods (FDA-cleared device and GC/MS).
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 or comparative effectiveness study involving human readers and AI assistance was conducted or described. This device is a rapid chromatographic immunoassay, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance evaluation was done. The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are intended to provide a preliminary analytical result without human interpretation beyond reading the visual line. Their performance was directly compared against a predicate device and GC/MS.
The type of ground truth used:
- The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered a gold standard for confirming the presence and concentration of substances in urine. Additionally, an existing FDA-cleared Oxycodone test served as a reference for comparison.
The sample size for the training set:
- The document does not specify a separate "training set" since this is a chemical immunoassay device, not typically an AI/machine learning model that undergoes a distinct training phase with a labeled dataset. The analytical studies (sensitivity, specificity, interference, precision, etc.) and clinical evaluation serve to validate the device's performance characteristics.
How the ground truth for the training set was established:
- As there's no explicit training set in the context of an AI/ML model, this question is not directly applicable. For the device itself, the chemical and biological principles governing its function are based on established scientific knowledge and empirical validation through "Performance Characteristics and Other information" studies described (analytical sensitivity, specificity, cross-reactivity, interference, precision, read time flex, temperature flex, specimen storage and stability). These studies use controlled samples with known compositions to characterize the device's fundamental behavior.

Summary

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FEB 1 7 2004

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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 K033041.

Submitter:

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

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

Date:

September 22, 2003

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® OXY One Step Oxycodone Test Strip ACON® OXY One Step Oxycodone Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Oxycodone in urine.

Regulation Name:

Opiates test system.

Product Code:

DIG

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Classification Number:

21 CFR. 862.3650

Device Classification:

The Oxycodone test systems have been classified as Class II devices with moderate complexity. The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are similar to another FDA-cleared device for the qualitative detection of Oxycodone 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® OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone in urine at a cutoff concentration of 100 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 OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device versus a FDA-cleared Oxycodone test with 100 ng/mL Oxycodone cutoff is shown below:

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Both tests are assays intended for the qualitative detection of Oxycodone 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 . Oxycodone 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 Oxycodone concentration of 100 ng/mL.

Safety and Effectiveness Data:

Accuracy

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

ACON OXY One Step Oxycodone Test Strip versus FDA-cleared Oxycodone Test:

Positive Agreement: 142 / 146 = 97% (93 % - 99 %) Negative Agreement: 154 / 154 = 100% (98 % - 100%**) Overall Agreement: 296 / 300 = 99% (97 % - 99 %) * 95% confidence intervals

** Since the proportion can not go above 100%, this is really a 97,5% confidence interval

ACON OXY One Step Oxycodone Test Device versus FDA-cleared Oxycodone Test:

Positive Agreement: 142 / 146 = 97% (93 % - 99 %) Negative Agreement: 154 / 154 = 100% (98 % - 100 % **) Overall Agreement: 296 / 300 = 99% (97 % - 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 OXY One Step Oxycodone Test Strip versus data obtained with GC/MS at the cutoff concentration of 100 ng/mL:

		Specimen Cut off Range by GC/MS Data				% Agreement withGC/MS Data
		Negative	<-25%Cutoff	-25% toCutoff	Cutoff to+25%	> +25%Cutoff
ACONOXY TestStrip	Positive	0	1	4	2	135	96%(92% - 98%)*
	Negative	147	2	6	1	2	98%(95% - 99%)*

Denotes 95% Confidence Interval.

ACON OXY One Step Oxycodone Test Device versus data obtained with GC/MS at the cutoff concentration of 100 ng/mL

		Specimen Cutoff Range by GC/MS Data				% Agreement with GC/MS Data
		Negative	< -25% Cutoff	-25% to Cutoff	Cutoff to > +25% Cutoff
ACONOXY TestDevice	Positive	0	1	4	135	96%(92% - 98%)*
	Negative	147	2	6	2	98%(95% - 99%)*

Denotes 95% Confidence Interval.

Performance Characteristics and Other information:

The performance characteristics of ACON OXY One Step Oxycodone Test Strip, ACON OXY One Step Oxycodone 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 OXY One Step Oxycodone Test Strip, ACON OXY One Step Oxycodone Test Device and a FDA-cleared Oxycodone test with the same Oxycodone cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Oxycodone at a concentration of 100 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

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Public Health Service

Food and Drug Administration 2098 Gaither Hoad Rockville MD 20850

FEB 1 7 2004

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

Re: K033047

Trade/Device Name: ACON® OXY One Step Oxycodone Test Strip ACON® OXY One Step Oxycodone Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiates test system Regulatory Class: Class II Product Code: DJG Dated: December 12, 2003 Received: December 18, 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 vours.

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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11. INDICATIONS FOR USE

510(k) Number:

ACON® OXY One Step Oxycodone Test Strip Device Name:

ACON® OXY One Step Oxycodone Test Device

<033047

Indications for Use:

Ahets
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033047

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

Prescription Use

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).