INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

K060527 · Alfa Scientific Designs, Inc. · DJG · Jul 25, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060527
• Device Name: INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

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 combination of the concentrations of BUP and NBUP is greater than 10 ng/ml. 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 Story

Lateral flow chromatographic immunoassay; detects buprenorphine and norbuprenorphine in human urine. Input: urine specimen; test strip contains conjugate pad with colloidal gold-labeled rabbit anti-buprenorphine antibodies and mouse IgG; nitrocellulose membrane with test line (Buprenorphine-BSA) and control line (goat anti-mouse IgG). Operation: specimen migrates via capillary action; competitive binding occurs; visual appearance of lines indicates presence or absence of drug. Output: qualitative visual result (preliminary positive if combined BUP/NBUP > 10 ng/ml). Used in clinical settings (physician offices, reference labs) by healthcare professionals. Results require confirmation via GC/MS or HPLC. Assists clinicians in identifying potential drug abuse; supports clinical decision-making.

Clinical Evidence

Clinical study of 94 specimens (54 confirmed positive via HPLC/MS or GC/MS, 40 drug-free). Overall agreement with reference methods was 96.8%. Sensitivity 96.3%, specificity 97.3%. Reproducibility study across three sites (two physician offices, one reference lab) showed 97.1% agreement for BUP and 98.4% for NBUP. Interference studies confirmed no impact from urine pH (3.0-9.0) or specific gravity (1.002-1.035).

Technological Characteristics

Lateral flow immunochromatographic assay. Materials: nitrocellulose membrane, buprenorphine-BSA, rabbit anti-buprenorphine antibodies, mouse IgG, colloidal gold, goat anti-mouse IgG. Cutoff: 10 ng/mL (combined BUP/NBUP). Visual readout. No instrumentation required. Single-use device.

Indications for Use

Indicated for the qualitative detection of buprenorphine and its metabolite, norbuprenorphine, in human urine specimens for healthcare professional use. Used for preliminary screening of drug abuse.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• OneStep Buprenorphine Test, New Bay Bioresearch, Co. Ltd.

Submission Summary (Full Text)

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Ka60527
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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: [phone] x 308 Submitter Fax: [phone] 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: [phone] + Fax: [phone] Web Site: www.alfascientific.com + E-mail: [e-mail]

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| Similarity to the<br>Predicate Device | · Both are one-step lateral-flow chromatographic immunoassays.<br>· Both are intended to provide qualitative detection of<br>buprenorphine abuse.<br>· Both are in-vitro diagnostic devices.<br>· Both have a built-in quality control feature, C line, to indicate<br>that an adequate volume of specimen is applied and the liquid<br>flow occurred properly |
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| Sensitivity and<br>Specificity | · The sensitivity of the proposed device is 96.3% and the<br>specificity is 97.3%. |
| Accuracy | Ninety four (94) clinical specimens were studied. Fifty four (54)<br>are HPLC/MS or GC/MS confirmed BUP/NBUP clinical<br>samples and forty (40) were drug free clinical samples. The<br>overall agreement of the proposed device to the HPLC/MS and<br>GC/MS is 96.8%. |
| Reproducibility | · This study was carried out at three (3) sites outside Alfa, two<br>Physician's Office Laboratories (POL) and one medical<br>reference laboratory. Evaluations were performed by personnel<br>with diverse educational backgrounds and working experiences.<br>· The agreement of the three sites is 97.1% for BUP and 98.4% for<br>NBUP. |
| Stability | To assess shelf life stability claims of the proposed test, accelerated<br>degradation of the proposed device was studied. Three lots from<br>each of the two formats (cassette and dip strip) were tested. Based<br>on the results from accelerated degradation study, two years (24<br>months) shelf life of the proposed test was predicted. |
| Urine Specific<br>Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to<br>1.035, and the pH of urine specimens, ranging from 3.0 to 9.0,<br>found no influence on this test results. |
| Formats of the<br>Device | The proposed device has two formats, cassette and dip-strip. The<br>cassette is a device that assembles a dip-strip in a plastic housing.<br>The studies demonstrate that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross<br>reactivity, and interference studies demonstrate that the proposed<br>test is substantially equivalent to the predicate device. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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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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 [phone]. 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 [phone] or [phone] 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:

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.

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