The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.

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 atchuid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory mcthods.

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 BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Buprenorphine 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 Buprenorphine in urine at a cutoff concentration of 10 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 Buprenorphine 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

The provided text describes the ACON BUP One Step Buprenorphine Test Strip and Device, which are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific percentages for positive, negative, or overall agreement. Instead, it presents the device's performance results against two comparators: a FDA-cleared Buprenorphine test and LC/MS analysis. The "acceptance" is implied by the FDA's substantial equivalence determination, meaning the performance was deemed acceptable relative to a legally marketed predicate.

However, we can infer performance targets for the purpose of demonstrating substantial equivalence. The reported performance is as follows:

Performance Metric	Acceptance Criteria (Implied by equivalence)	ACON BUP One Step Test Strip Reported Performance (95% CI)	ACON BUP One Step Test Device Reported Performance (95% CI)
Vs. FDA-cleared BUP Test
Positive Agreement	High agreement	84% (73% - 92%)	84% (73% - 92%)
Negative Agreement	Very high agreement	99% (97% - 99%)	99% (97% - 99%)
Overall Agreement	High agreement	95% (91% - 98%)	95% (91% - 98%)
Vs. LC/MS (Cutoff: 10 ng/mL)
Positive Agreement	High agreement (for positive specimens)	98% (90%-99%) (55/56)	98% (90%-99%) (55/56)
Negative Agreement	Very high agreement (for negative specimens)	>99% (98%-100%) (170/170)	>99% (98%-100%) (170/170)
Total Agreement	Very high agreement	99.6% (98% - 99%)	99.6% (98% - 99%)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for the Test Set: 226 clinical urine specimens.
Data Provenance: The document does not specify the country of origin. The study used "clinical urine specimens," implying they were collected from real-world patients, but it doesn't state if they were collected retrospectively or prospectively. Given the context of a 510(k) submission and the term "clinical evaluation," it's likely a retrospective collection of samples with known Buprenorphine concentrations or confirmed by an existing method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by:

Comparison with an FDA-cleared Buprenorphine test.
Comparison with Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is considered the "gold standard" for drug confirmation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method involving human readers is described for the test set. The comparisons are entirely based on the results from the devices, the predicate device, and LC/MS.

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 kit, not an AI-powered diagnostic system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was conducted. The ACON BUP One Step Buprenorphine Test Strip and Test Device are intended to be used as standalone tests, providing a qualitative result. The "Safety and Effectiveness Data" section details the performance of these devices in comparison to existing methods without any human-in-the-loop assistance for interpretation beyond reading the visual result of the strip/device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluation was established using:

Comparison against an FDA-cleared predicate Buprenorphine test.
Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is a highly specific and sensitive analytical method considered definitive for drug identification and quantification.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an algorithm that requires training data. The development and validation of the immunoassay itself would have involved laboratory testing and optimization, but not a "training set" in the computational sense.

9. How the ground truth for the training set was established

As there is no mention of a training set for an algorithm, this question is not applicable to the described device.

Summary

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5. 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 K060466

Submitter:

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

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

Date:

February 21, 2006

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® BUP One Step Buprenorphine Test Strip ACON® BUP One Step Buprenorphine Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Buprenorphine in urine.

Regulation Name:

Buprenorphine test system.

Product Code:

DIG

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Classification Number:

21 CFR, 862.3650

Device Classification:

The Buprenorphine test systems have been classified as Class II devices with moderate complexity. 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 LC/MS analysis.

Intended Use:

The ACON BUP One Step Buprenorphine Test Strip and ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in urine at a cutoff concentration of 10 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 LC/MS analysis. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.

Description:

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 226 clinical urine specimens including approximately 10% of the specimens containing Buprenorphine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON BUP One Step Buprenorphine Test Strip and ACON BUP One Step Buprenorphine Test Device with a FDAcleared Buprenorphine test; as well as compared against data obtained from the customary

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Liquid Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:

ACON BUP One Step Buprenorphine Test Strip versus a FDA-cleared BUP Test:

Positive Agreement: 54 / 64 = 84% (73% - 92%)* Negative Agreement: 161 / 162 = 99% (97% - 99%)* Overall Agreement: 215 / 226 = 95% (91% - 98%)* * 95% confidence intervals

ACON BUP One Step Buprenorphine Test Device versus a FDA-cleared BUP Test:

Positive Agreement: 54 / 64 = 84% (73% - 92%)* Negative Agreement: 161 / 162 = 99% (97% - 99%)* Overall Agreement: 215 / 226 = 95% (91% - 98%)* * 95% confidence intervals

ACON BUP One Step Buprenorphine Test Strip versus data obtained with LC/MS at the cutoff concentration of 10 ng/mL:

ACON BUP One Step Buprenorphine Test Strip versus LC/MS.

		Specimen Cutoff Range by LC/MS Data
		Negative	<-25% Cutoff	-25% to Cutoff	Cutoff to +25%	> +25% Cutoff	% Agreement
ACON BUPTest Strip	Positive	0	0	0	5	50	98% (55/56)(90%-99%)*
	Negative	150	15	5	1	0	>99% (170/170)(98%-100%)**

Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)* * Denotes 95% confidence interval.

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

ACON BUP One Step Buprenorphine Test Device versus LC/MS.

	Specimen Cutoff Range by LC/MS Data
	Negative	< -25% Cutoff	-25% to Cutoff	Cutoff to +25%	> +25% Cutoff	% Agreement
ACON BUPTest Device	Positive	0	0	0	50	98% (55/56)(90% - 99%)*
	Negative	150	15	5	1	0

Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)*

Denotes 95% confidence interval.

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

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Performance Characteristics and Other information:

The performance characteristics of the ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine 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 BUP One Step Buprenorphine Test Strip, the ACON BUP One Step Buprenorphine Test Device and a FDA-cleared Buprenorphine test with the same Buprenorphine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Buprenorphine at a concentration of 10 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 a black and white emblem. The emblem features a stylized bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text, which appears to be the name of an organization or agency. The overall design is circular and professional.

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

APR 2 1 2006

Re: K060466

Trade/Device Name: ACON BUP One Step Buprenorphine Test Strip ACON BUP One Step Buprenorphine Test Device Regulation Number: 21 CFR§862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: February 21, 2006 Received: February 22, 2006

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, Orug 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, EDA 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 af 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 pratis 1 requirements as set forth in the quality systems (QS) regulation (21 CFR Pris B20).

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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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutt

Alberto Gutierrez, Ph.D. 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): Ko 60466)

Device Name: ACON BUP One Step Buprenorphine Test Strip

ACON BUP One Step Buprenorphine Test Device

Indications for Use:

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)

In Vitro Disanostic Dovice

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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).