For Sure One Step Buprenorphine Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

Device Description

For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line 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 information for the "For Sure Buprenorphine Rapid Test Card" based on the provided text:

Important Note: The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed study report with all the specific performance metrics and methodologies that would typically be found in a full scientific publication or comprehensive regulatory submission. Therefore, some requested information (like specific sample sizes for test and training sets, number and qualifications of experts, and MRMC study details) is not explicitly stated in this document.

Acceptance Criteria and Reported Device Performance

The document implies acceptance criteria based on the comparison to the predicate device and the intended use. The primary performance metric mentioned is the device's ability to qualitatively determine the presence of buprenorphine at a specific cutoff concentration.

Acceptance Criteria (Implied)	Reported Device Performance
Qualitative Detection of Buprenorphine at 10 ng/ml Cutoff	The device provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine at a cutoff concentration of 10 ng/ml.
Consistency with Intended Use	The device's intended use is for immunochromatographic enzyme immunoassay for qualitative determination of buprenorphine in human urine.
Substantial Equivalence to Predicate Devices	Demonstrated through comparison of intended use, analytical properties (analyte, cutoff, matrix), and operational characteristics (instrument, calibration, storage) to CEDIA Buprenorphine ASSAY (K040316) and GC/MS.
Demonstrates Reagent and Device Functioning (Control Zone)	Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Absence of False Negatives (above cutoff)	The drug or drug metabolites in the sample compete with a drug conjugate. If the drug is above the detection level of 10 ng/ml of Buprenorphine, it will not produce a magenta color band in the test reaction zone.
Absence of False Positives (below cutoff)	A NEGATIVE specimen produces two distinct color bands in both the test line and control area. (Implies no test line appears if below cutoff.)

Study Details

Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The submission is from Tianjin New Bay Bioresearch Co., Ltd. in China, but the origin of the urine samples used for testing is not detailed. It is also not specified if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, the preferred confirmatory method for ground truth is Gas Chromatography/Mass Spectrometry (GC/MS), which would typically be performed and interpreted by qualified laboratory personnel (e.g., toxicologists, chemists).
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. The document refers to GC/MS as the preferred confirmatory method, implying this is the gold standard for ground truth, rather than an adjudication among human readers for the device itself.
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:
- MRMC Study: No. This device is a rapid, visual immunoassay test card, not an AI-powered diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, in the sense that the test card itself provides a visual result (presence or absence of a line) without needing a human to interpret complex data from an algorithm. The reading is visual: "A NEGATIVE specimen produces two distinct color bands... A POSITIVE specimen produces only one color band in the control area." This is the "algorithm only" performance for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Gas chromatography /mass spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method for obtaining confirmed analytical results. This serves as the gold standard ground truth.
The sample size for the training set:
- Sample Size (Training Set): Not explicitly stated. This document primarily focuses on the substantial equivalence study for regulatory clearance, not the development process of the immunoassay itself.
How the ground truth for the training set was established:
- Ground Truth (Training Set): Not explicitly stated. Again, the document focuses on regulatory clearance. However, it's highly probable that similar laboratory methods, likely GC/MS, would have been used during the development and optimization (training) phase of the immunoassay to establish its performance characteristics against known samples.

Summary

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March 30th, 2005 SECTION II 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

51O}k) Number: Design K # 042988

Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516

Contact Person:

Rodrigo Berlie Marketing Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999

Preparation Date:

March 30, 2005

Device Information:

Device Classification Name: Immunoassay, Buprenorphine Common/Usual Name: Immunoassay Test System for detection of Buprenorphine in Human Urine Proprietary Name: Rapid One Step Buprenorphine Test Card, For Sure Buprenorphine Rapid Test Card Regulation Number: 21 CFR§862.3650 Regulatory Name: Buprenorphine test system Product Code: DJG Regulatory Class: Class II

Predicate Devices:

For Sure Buprenorphine Rapid Test Card is substantially equivalent to The CEDIA® Buprenorphine Assay cleared by FDA (K040316), and GC/MS for its stated intended use.

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Device Description:

Intended Use:

For Sure Buprenorphine Rapid Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.

Comparison to Predicate Device(s):

For Sure Buprenorphine Test Card is substantially equivalent to CEDIA buprenorphine test system cleared by FDA, e.g., the CEDIA Buprenorphine Assay (K040316) and GC/MS for its stated intended use.

Device Characteristics	Subject Device (For SureBuprenorphine Test Card)	Predicate Device(s)CEDIA Buprenorphine Assay(K040316) and GC/MS
Intended Use	Buprenorphine one-stepImmunochromatographic test cardwith 10 ng/ml cutoff. The assayprovides a simple and rapidanalytical screening procedure todetect buprenorphine in human urine	The CEDA® Buprenorphine assay ishomogenous enzyme immunoassayfor qualitative or semi-quantitativedetermination of the presence ofbuprenorphine in human urine atcutoff concentration of 5 ng/ml.
Analyte	Buprenorphine	Buprenorphine
Cutoff	10 ng / ml	5 ng/ml

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Matrix	Urine	Urine
Calibrator	None	5 levels (0,5,20,50 and 75 mg/ml
Instrument	None, Visual read single use	Expensive Auto-analyzer
Calibration of Reagent	None	Yes, multiple reagents requirecalibration.
Storage	Below 28 ℃ until expiration	2℃ - 8℃ until expiration date

Summary:

The information provided in this pre-market notification demonstrates that the Rapid One The Information provine Test Card is substantially equivalent to CEDIA Buprenorphine test assay system and GC/MS.

assay system and OCAND.
Substantial equivalence was demonstrated through comparison of intended use and Davical properties to the commercially available and analytical predicate devices. The physiour property to this pre-market notification provides reasonable assurance that mormation bappired in neworphine Test Card is safe and effective for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie Marketing Director Aviara Biotech, LLC. 2720 Loker Ave-West Suite U Carlsbad, CA 92008

Re: K042988

Trade/Device Name: For Sure One Step Buprenorphine Test Card Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: April 28, 2005 Received: May 2, 2005

MAY 1 2 2005

Dear Mr. Berlie:

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 for are version 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 or any 1 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) I mis lotter will anon your your of substantial equivalence of your device to a legally premarket notification - 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 of questions on the promotion 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 Tou may 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,

Carol C. Benson

Carol C. Benson, M.A. Acting 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 STATEMENT

510(k) Number (if known): K042988

Device name: For Sure One Step Buprenorphine Test Card Device

Indications for Use:

For Sure One Step Buprenorphine Test Card is an immunochromatographic immunoassay for qualitative determination of the presence of buprenorphine in human minutioassay for qualitative of 10 ng/ml. The assay provides a simple and rapid urine at catorr oonoonareedure to detect buprenorphine in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative The assay provides ost be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test results particularly when preliminary results are used.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

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

Allent Catz
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K04298

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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).