The ForSure One Step Buprenorphine Drug Cup Test Device is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at cutoff level of 10 ng/mL. The test is intended for prescription and overthe-counter use.

The buprenorphine assay will yield preliminary positive results when buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The ForSure One Step Buprenorphine Drug Cup Test Device shows the drug was or was not present at the cutoff level. The assay provides only a preliminary analytical test result.

A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

Device Description

ForSure" One Step Buprenorphine Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder which is able to hold the QuikStrip of Buprenorphine within the container. The membrane of the test strip is coated with goat anti-mouse antibody and Buprenorphine-Bovine serum albumin conjugate. The sample pad contains a colloidal gold-labeled mouse monoclonal anti-Buprenorphine antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone 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. The test is easy and fast allowing the user to visually read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the Buprenorphine result shows 1 line (preliminary positive) you should send the sample for laboratory testing.

AI/ML Overview

The provided document describes the ForSure™ One Step Buprenorphine Drug Cup Test Device (K122064). This summary focuses on the acceptance criteria and study information as requested.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity	Acceptance: ≥10ng/ml Buprenorphine in urine show positive result (Implied from predicate and subject device consistency)
Total Precision	Acceptance: No appreciable within and inter-lot variation for positive and negative spiked samples across three (3) different lots at different days (Implied from predicate and subject device consistency)
Cutoff Determination	Acceptance: Cutoff at 10 ng/ml. 50% below cutoff are negative. Cutoff and 25% above cutoff are positive. (Implied from predicate and subject device consistency)
Accuracy	Acceptance: Comparison study of positive and negative specimens with GC/MS shows very good correlation. (Implied from predicate and subject device consistency)
Assay Time	Acceptance: 5 minutes (Explicitly stated in comparison table)
Matrix	Acceptance: Urine (Explicitly stated in comparison table)
Preliminary Positive Reconfirmation	Acceptance: Yes, by GC/Mass (Explicitly stated in comparison table)

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "A comparison study of positive and negative specimens with GC/MS was performed" for accuracy, without providing specific numbers of specimens.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the number of experts used or their qualifications for establishing ground truth. The ground truth method used (GC/MS) is an objective analytical method, not dependent on expert interpretation in the same way as, for example, image review by radiologists.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a definitive analytical method and does not typically involve adjudication among human experts for preliminary results.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a "visual read single use" diagnostic, where results are read directly, not through interpretation by multiple human readers that would then be compared to AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device itself is a standalone diagnostic tool, as it is a "visual read single use" lateral flow immunoassay. The intended use description explicitly states, "The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine." This indicates its standalone performance provides a preliminary result, with confirmatory testing (GC/MS or LC/MS) recommended for positive findings. The performance metrics (Sensitivity, Precision, Cutoff, Accuracy) are related to this standalone analytical performance.

7. Type of Ground Truth Used

The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states: "A comparison study of positive and negative specimens with GC/MS was performed." It also mentions Liquid Chromatography/Mass Spectrometry (LC/MS) as another preferred confirmatory method.

8. Sample Size for the Training Set

The document does not provide information on a "training set" sample size. This device is a lateral flow immunoassay, which is a chemical and biological test, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its development would involve chemical and biological optimization, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/machine learning algorithm, this question is not applicable. The development of this immunochromatographic assay relies on established biochemical principles and would involve iterative testing against known concentrations of Buprenorphine and its metabolites, similar to how the performance metrics (sensitivity, cutoff, accuracy) are assessed.

Summary

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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.

510(k) Number: K122064

Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #1 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516

Contact Person:

Mr. Roger De Bock SDbiotek, LLC. 4455 Murphy Canyon Road Suite 204 San Diego, CA 92123 email: rdebock@sdbiotek.com Tel: 619-453-0930 (O) Tel: 619-994-1417 (C) Fax: 858-569-4243 Preparation Date: 04,19 2013

Device Information:

Trade or Proprietary Name: ForSure™ One Step Buprenorphine Drug Cup Test Device.

Common/Usual Name:

Lateral flow immunochromatographic assay for detection of Buprenorphine in human urine

Device Classification Name:

Immunoassay of Buprenorphine

Regulatory Name:

Buprenorphine Test System

Regulation Section: 21 CFR § 862.3650

Regulatory Class: Class II

Product Code: DJG

Panel: Toxicology (91)

Predicate Devices:

ForSure™ One Step Buprenorphine Drug Cup Test Device is substantially equivalent to predicate device (ForSure " One Step Buprenorphine Test Strip Device) cleared by FDA (K042990) for its stated intended use.

Device Description:

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labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone 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. The test is easy and fast allowing the user to visually read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the Buprenorphine result shows 1 line (preliminary positive) you should send the sample for laboratory testing.

ForSure 100 One Step Buprenorphine Drug Cup Screen Test is for diagnostic and treatment purposes, consult with a healthcare or substance abuse professional.

Intended Use:

The Buprenorphine assay will vield preliminary positive results when buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The ForSure One Step Buprenorphine Drug Cup Test Device shows the drug was or was not present at the cutoff level. The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

Comparison to Predicate Device(s):

Tianjin New Bay ForSure™ One Step Buprenorphine Drug Cup Test is substantially equivalent to
Tianjin New Bay ForSure ™ One Step Buprenorphine Strip Test cleared by the FDA (

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DeviceCharacteristics	Subject Device (s)Tianjin New Bay ForSureTMOneStep Buprenorphine Drug CupTest device.	Predicate Device(s)Tianjin New Bay ForSureTMOneStep Buprenorphine Strip Test(K 042990)
Intended Use	ForSureTM Buprenorphine One StepImmunochromatographic Drug CupQualitative test.The assay provides a simple andrapid analytical screening procedureto detect Buprenorphine and itsmetabolite drugs in human urine .	ForSureTM One Step BuprenorphineImmunochromatographicQualitative Strip test.The assay provides a simple andrapid analytical screeningprocedure to detect Buprenorphinein human urine	same
Analytes	Buprenorphine	Buprenorphine	same
Chemistry formulationand Antibody Used in	Antibody and chemistry formulationused for drug on the test strip are	Using monoclonal /polyclonalantibody for the colloidal gold	same
the device	100% identical to the strips approvedby FDA (K042990)	conjugate, Drug-BSA conjugate forthe test line of the membrane	same
Cutoff	Buprenorphine: 10 ng/ml,	Buprenorphine: 10ng/ml,	same
Assay time	5 minutes	5 minutes	same
Preliminary PositiveReconfirm by GC/Mass	Yes	Yes	same
Matrix	Urine	Urine	same
Calibrator	None	None	same
Instrument	None, Visual read single use	None, Visual Read single use	same
Calibration of Reagent	None	None	same
Storage	Below 28°C until expiration	Below 28°C until expiration	same

: : : : : :

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Subject Device:

Sensitivity: ≧10ng /ml of Buprenorphine in urines show positive result

Total Precision: The results demonstrate that there is no appreciable within and inter lot variation when testing both positive and negative spiked samples across three (3) different lots of test device at different day. The test result of both within lot and inter lot reproducibility are similar to Predicate device.

Cutoff determination: The cutoff is 10 ng/ml of Bup. 50% below the cutoff level of Buprenorphine are negative. The result set at cutoff and 25 % above cutoff level of Buprenorphine are positive and similar to the predicate device.

Accuracy: A comparison study of positive and negative specimens with GC/MS was performed, the test results was correlated very well with GC/MS. It is similar to the predicate device

Predicate:

Sensitivity: ≧10ng /ml of Buprenorphine in urines show positive result

Cutoff determination: The cut off is 10 ng/ml of BUP.50% below the cutoff level of Buprenorphine are negative. The result set at cutoff and 25% above cutoff level of Buprenorphine are positive.

Accuracy: A comparison study of positive and negative specimens with GC/MS was performed, the test results was correlated very well with GC/MS.

Same

Performance Comparison

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Summary:

The information provided in this pre-market notification demonstrates that ForSure™ One Step Buprenorphine Strip Test Device (K 042990) and GC/MS.

Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the ForSure™ One Step Buprenorphine Drug Cup Test Device is safe and effective for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2013

Tianjin New Bay Bioresearch Co., Ltd. C/O Roger De Bock S.D. Biotek, LLC 4455 Murphy Canyon Road SAN DIEGO CA 92123

Re: K122064

Trade/Device Name: ForSure™ One Step Buprenorphine Drug Cup Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: February 05, 2013 Received: April 02, 2013

Dear Mr. De Bock:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. De Bock

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122064

Device Name: ForSure One Step Buprenorphine Drug Cup Test Device

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.05.01 07:20:42 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K122064

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).