For Sure One Step Buprenorphine Strip Test Device 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

The For Sure One Step Buprenorphine Strip Test Device consists of a chromatographic The For Barevice in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled As the test sumple no we the free drug in the specimen forming an antibody-antigen annoote) - ouslex competes with immobilized antigen conjugate in the Test complex. This one and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml 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 produces only one color band in the control area. There is no meaning attributed to color or its intensity for either 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 summary of the acceptance criteria and the study details for the For Sure One Step Buprenorphine Strip Test Device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be implicit in the claim of substantial equivalence to the predicate device and GC/MS. The study aims to demonstrate that the device performs comparably to these methods for qualitative detection of buprenorphine in urine.

The reported device performance is described qualitatively by comparing its characteristics to the predicate device.

Characteristic	Acceptance Criteria (Implicit from Predicate and GC/MS)	Reported Device Performance (For Sure One Step Buprenorphine Strip Test Device)
Intended Use	Qualitative determination of buprenorphine in human urine	Qualitative determination of buprenorphine in human urine
Cutoff Concentration	5 ng/ml (for CEDIA predicate)	10 ng/ml
Analyte	Buprenorphine	Buprenorphine
Matrix	Urine	Urine
Instrument	Automated analyzer (predicate), Mass Spectrometer (GC/MS)	None, Visual read, Single Use
Calibration	Yes, multiple reagents require calibration (predicate)	None
Storage	2°C - 8°C until expiration date (predicate)	Below 28 °C until expiration

Note: The primary performance mentioned is the stated cutoff concentration of 10 ng/ml. The document states that a negative specimen produces two distinct color bands, and a positive specimen produces only one color band in the control area when the drug is above the detection level of 10 ng/ml. This outlines the expected visual interpretation.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The provided text does not specify any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted based on the provided text. The device is a "one-step strip test" with visual interpretation, and the comparison is primarily to laboratory-based methods (CEDIA assay and GC/MS).

6. Standalone Performance

Yes, a standalone performance assessment was done. The device's performance is described in terms of its ability to detect buprenorphine at a specific cutoff concentration (10 ng/ml) through a visual read. The comparison study evaluates this standalone performance relative to established methods.

7. Type of Ground Truth Used

The ground truth for comparison is primarily established by:

Predicate Device: The CEDIA® Buprenorphine Assay (K040316).
Confirmatory Method: Gas Chromatography/Mass Spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method.

This implies that GC/MS serves as the gold standard or reference method for confirming the presence or absence of buprenorphine in samples.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set. This is a point-of-care, visually read immunoassay device, and typically, such devices are developed/calibrated using laboratory testing rather than traditional machine learning training sets.

9. How Ground Truth for the Training Set was Established

The provided text does not explicitly describe how ground truth for a "training set" was established. Given the nature of the device (a qualitative immunoassay), the development likely involved:

Spiking studies: Urine samples would be spiked with known concentrations of buprenorphine to determine the device's analytical sensitivity and cutoff performance.
Comparison to reference methods: Similar to the test set, initial development and optimization would likely involve comparing the strip test results to established laboratory methods like GC/MS to confirm accuracy at various concentrations.

The mechanism of the device itself (competition with antibody sites resulting in color band formation) indicates its operational principle is based on known chemical reactions, not on learning from a "training set" in the context of AI or machine learning.

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: K042990

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 New Product Development 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 Strip Buprenorphine Test, For Sure One Step Buprenorphine Strip Test Device Regulation Number: 21 CFR§862.3650 Regulatory Name: Buprenorphine test system Product Code: DJG Regulatory Class: Class II

Predicate Devices:

For Sure One Step Buprenorphine Strip Test Device 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:

Comparison to Predicate Device(s):

For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to CEDIA buprenorphine test system cleared by FDA, e.g., the CEDIA Buprenorphine Assay (040316) and GC/MS for its stated intended use.

Device Characteristics	Subject Device	Predicate Device(s)CEDIA Buprenorphine Assay(K040316) and GC/MS
Intended Use	Buprenorphine one-stepImmunochromatographic test with10ng/ml cutoff.The assay provides 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
Cut Off	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 °C until expiration	2°C - 8°C until expiration date

Summary:

The information provided in this pre-market notification demonstrates that the For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to CEDIA Buprenorphine test assay system and GC/MS.

Dubstantial equivalence was demonstrated through comparison of intended use and Dabbanalar equitation mercially available and analytical predicate devices. The percentation supplied in this pre-market notification provides reasonable assurance that mormation buppens in uprenorphine Strip Test Device is safe and effective for its stated intended 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 lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 0 2005

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

K042990 Re:

Ro42770
Trade/Device Name: For Sure One Step Buprenorphine Strip Test 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

Dear Mr. Berlie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your collection in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to regions and ment date of the Medical Device Amendments, or to conimores 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). and Cosmetic (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I va may, merelove, mains of the Act include requirements for annual registration, listing of general voluled provision 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 it may be subject to Satin Cash Regulations (CFR), Parts 800 to 895. In addition, FDA ean oc found in firther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be devised that I Drivination that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must of any I cacrated and the Act's requirements, including, but not limited to: registration and listing (21 comply with and 110 (21 CFR Parts 801 and 809); and good manufacturing practice er rant 007), accensed 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 letter witi anow you to organ maining of substantial equivalence of your device to a legally premainer notificated in ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' 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 vitro Diagnoution De 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 obtain other general 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. Benem

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): K042990

Device name: For Sure One Step Buprenorphine Strip Test Device

Indications for Use:

For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic I of Sure One Deprenerprints 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 I he assay provides ost ) a used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Chiromatography Amaso op sent should be applied to any drug of abuse test results particularly when preliminary results are used.

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

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

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

Alle & Siel,

ivision Sign-

Office of In Vitro Diagnostic Device Evaluation and Safety

51090 K042990

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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).