The proposed BUP/NBUP Urine Test is a qualitative immunoassay for the rapid detection of buprenorphine and norbuprenorphine from human urine specimens. The test provides only a preliminary result. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Device Description

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Rabbit anti-buprenorphine antibodies and mouse IgG, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with Buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibodies.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® BUP/NBUP Urine Test, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity	96.3%
Specificity	97.3%
Accuracy	96.8% overall agreement with GC/MS or HPLC/MS
Reproducibility	97.1% for BUP (across 3 sites) 98.4% for NBUP (across 3 sites)
Stability	Predicted 2 years (24 months) shelf life (based on accelerated degradation)
Urine Specific Gravity Influence	No influence found for specific gravity ranging from 1.002 to 1.035
Urine pH Influence	No influence found for pH ranging from 3.0 to 9.0
Formats Equivalence	Cassette and dip-strip formats demonstrated to be equivalent

Study Details

Sample size used for the test set and the data provenance:
- Test Set Size: 94 clinical specimens.
  - 54 specimens were confirmed BUP/NBUP clinical samples.
  - 40 specimens were drug-free clinical samples.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical specimens," suggesting real-world samples. It does not specify if the data was retrospective or prospective, but the use of "clinical specimens" often implies a retrospective collection for such validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by HPLC/MS or GC/MS (High-Performance Liquid Chromatography/Mass Spectrometry or Gas Chromatography/Mass Spectrometry), which are analytical gold standard methods, not human experts. Therefore, the concept of "experts" in the traditional sense for establishing ground truth does not directly apply here. These methods are considered highly accurate and serve as the definitive reference.
Adjudication method for the test set:
- Not applicable as the ground truth was established by analytical methods (HPLC/MS or GC/MS), not human interpretation requiring adjudication.
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, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is a qualitative immunoassay for chemical detection, not an AI-assisted diagnostic imaging or interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device itself performs the detection (algorithm/chemical reaction only), producing a "preliminary positive" or negative result without direct human-in-the-loop performance influencing the result generating mechanism. The "human-in-the-loop" aspect comes in the interpretation of the preliminary result and the need for confirmatory testing.
The type of ground truth used:
- Analytical Gold Standard / Confirmatory Chemical Method: HPLC/MS or GC/MS confirmed results.
The sample size for the training set:
- The document does not explicitly mention a "training set" for the primary performance metrics (sensitivity, specificity, accuracy). Immunoassays typically rely on biochemical reactions rather than machine learning models that require distinct training and test sets in the same way. The 94 clinical specimens are referred to as the "studied" or "test" set for performance evaluation.
How the ground truth for the training set was established:
- As no explicit "training set" is described in the context of machine learning, this question isn't directly applicable. For the samples used in the performance evaluation, the ground truth was established by HPLC/MS or GC/MS.

Summary

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Ka60527
nsai

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Alfa Scientific Designs, Inc.

FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM

JUL 25 2006

I.S. EN 4600

510(k) Summary

Safety and Effectiveness as Required by 21 CFR 807.92

Alfa Scientific Designs, Inc. Name: 13200 Gregg Street Address: Manufacture and Poway, CA 92064 Telephone: (858) 513-3888 x 308 Submitter Fax: (858) 513-8388 Naishu Wang, MD, Ph.D. Contact Person: E-mail: wnss(a)alfascientific.com Trade Name: INSTANT-VIEW® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-VERDICT® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-CONFIRMATORY® BUP/NBUP Urine Test (Cassette, Dip-Strip) Common Name: Device Name Immunoassay, BUP/NBUP Urine Test Classification: Immunoassay, Opiates Product Code: DJG Date of Summary February 20, 2006 Preparation 510K Number: K042988 Predicate Device OneStep Buprenorphine Test, New Bay Bioresearch, Co. Ltd. A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Rabbit anti-buprenorphine Device Description antibodies and mouse IgG, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with Buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibodies. This device is a qualitative immunoassay intended to detect buprenorphine (BUP) and its metabolite, norbuprenorphine (NBUP) in human urine. Results are preliminary positive when the Intended Use combination of the concentrations of BUP and NBUP is greater than 10 ng/ml. It is for health care professional use only.

13200 Gregg Street, Poway, CA 92064, USA + Telephone: 858-513-3888 + Fax: 858-513-8388 Web Site: www.alfascientific.com + E-mail: sales@alfascientific.com

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Similarity to thePredicate Device	· Both are one-step lateral-flow chromatographic immunoassays.· Both are intended to provide qualitative detection ofbuprenorphine abuse.· Both are in-vitro diagnostic devices.· Both have a built-in quality control feature, C line, to indicatethat an adequate volume of specimen is applied and the liquidflow occurred properly
Sensitivity andSpecificity	· The sensitivity of the proposed device is 96.3% and thespecificity is 97.3%.
Accuracy	Ninety four (94) clinical specimens were studied. Fifty four (54)are HPLC/MS or GC/MS confirmed BUP/NBUP clinicalsamples and forty (40) were drug free clinical samples. Theoverall agreement of the proposed device to the HPLC/MS andGC/MS is 96.8%.
Reproducibility	· This study was carried out at three (3) sites outside Alfa, twoPhysician's Office Laboratories (POL) and one medicalreference laboratory. Evaluations were performed by personnelwith diverse educational backgrounds and working experiences.· The agreement of the three sites is 97.1% for BUP and 98.4% forNBUP.
Stability	To assess shelf life stability claims of the proposed test, accelerateddegradation of the proposed device was studied. Three lots fromeach of the two formats (cassette and dip strip) were tested. Basedon the results from accelerated degradation study, two years (24months) shelf life of the proposed test was predicted.
Urine SpecificGravity and pH	The specific gravity of urine specimens, ranging from 1.002 to1.035, and the pH of urine specimens, ranging from 3.0 to 9.0,found no influence on this test results.
Formats of theDevice	The proposed device has two formats, cassette and dip-strip. Thecassette is a device that assembles a dip-strip in a plastic housing.The studies demonstrate that the two formats are equivalent.
Conclusion	The results of specificity, sensitivity, reproducibility, crossreactivity, and interference studies demonstrate that the proposedtest is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 13200 Gregg Street Poway, CA 92064

JUL 25 2006

Re: K060527

Trade/Device Name: INSTANT-VIEW® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-VERDICT® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-CONFIRMATORY® BUP/NBUP Urine Test (Cassette, Dip-Strip) Regulation Number: 21 CFR§ 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: July 14, 2006 Received: July 17, 2006

Dear Dr. Wang:

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 (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 vours.

Alberto Guti

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): K060527

Device Name: INSTANT-VIEW® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-VERDICT® BUP/NBUP Urine Test (Cassette, Dip-Strip) INSTANT-CONFIRMATORY® BUP/NBUP Urine Test (Cassette, Dip-Strip)

Indications For Use:

Prescription Use (Pert 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)

Klaus 37

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).