(147 days)
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No
The device description and performance studies describe a standard lateral flow immunoassay, with no mention of AI or ML technologies.
No
This device is a diagnostic test kit for detecting substances in urine, not a device used for therapy or treatment.
Yes
The device qualitatively detects buprenorphine and norbuprenorphine from human urine specimens, providing a preliminary result that aids in diagnosing drug use.
No
The device description clearly states it is a "one-step lateral flow chromatographic immunoassay" with physical components like a "burgundy-colored conjugate pad" and a "nitrocellulose membrane," indicating it is a hardware-based test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid detection of buprenorphine and norbuprenorphine from human urine specimens." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of buprenorphine/norbuprenorphine).
- Device Description: The description details a "lateral flow chromatographic immunoassay," which is a common technology used in IVD tests. It describes the components that interact with the biological sample to produce a result.
- Performance Studies: The document includes performance studies evaluating the device's accuracy, reproducibility, and stability using clinical specimens. This type of testing is required for IVD devices to demonstrate their reliability and effectiveness.
- Key Metrics: The document provides key metrics like sensitivity and specificity, which are standard measures used to evaluate the performance of diagnostic tests.
- Predicate Device: The mention of a predicate device (K042988 OneStep Buprenorphine Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The fact that it's for "health care professional use only" and provides a "preliminary result" that requires confirmation by other methods (like GC/MS or HPLC) does not negate its classification as an IVD. Many IVDs are designed for professional use and provide screening or preliminary results that need further investigation.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG
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. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy:
Ninety four (94) clinical specimens were studied. Fifty four (54) are HPLC/MS or GC/MS confirmed BUP/NBUP clinical samples and forty (40) were drug free clinical samples. The overall agreement of the proposed device to the HPLC/MS and GC/MS is 96.8%.
Reproducibility:
This study was carried out at three (3) sites outside Alfa, two Physician's Office Laboratories (POL) and one medical reference laboratory. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 97.1% for BUP and 98.4% for NBUP.
Stability:
To assess shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results from accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
Urine Specific Gravity and pH:
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, found no influence on this test results.
Formats of the Device:
The proposed device has two formats, cassette and dip-strip. The cassette is a device that assembles a dip-strip in a plastic housing. The studies demonstrate that the two formats are equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The sensitivity of the proposed device is 96.3% and the specificity is 97.3%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Ka60527
nsai
Image /page/0/Picture/2 description: The image shows a stylized depiction of the Greek letter alpha. The letter is drawn in a decorative font, with overlapping strokes and a textured fill. The overall impression is one of classic elegance and artistic flair.
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
1
| Similarity to the
Predicate Device | · Both are one-step lateral-flow chromatographic immunoassays.
· Both are intended to provide qualitative detection of
buprenorphine abuse.
· Both are in-vitro diagnostic devices.
· Both have a built-in quality control feature, C line, to indicate
that an adequate volume of specimen is applied and the liquid
flow occurred properly |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity and
Specificity | · The sensitivity of the proposed device is 96.3% and the
specificity is 97.3%. |
| Accuracy | Ninety four (94) clinical specimens were studied. Fifty four (54)
are HPLC/MS or GC/MS confirmed BUP/NBUP clinical
samples and forty (40) were drug free clinical samples. The
overall agreement of the proposed device to the HPLC/MS and
GC/MS is 96.8%. |
| Reproducibility | · This study was carried out at three (3) sites outside Alfa, two
Physician's Office Laboratories (POL) and one medical
reference laboratory. Evaluations were performed by personnel
with diverse educational backgrounds and working experiences.
· The agreement of the three sites is 97.1% for BUP and 98.4% for
NBUP. |
| Stability | To assess shelf life stability claims of the proposed test, accelerated
degradation of the proposed device was studied. Three lots from
each of the two formats (cassette and dip strip) were tested. Based
on the results from accelerated degradation study, two years (24
months) shelf life of the proposed test was predicted. |
| Urine Specific
Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to
1.035, and the pH of urine specimens, ranging from 3.0 to 9.0,
found no influence on this test results. |
| Formats of the
Device | The proposed device has two formats, cassette and dip-strip. The
cassette 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, cross
reactivity, and interference studies demonstrate that the proposed
test is substantially equivalent to the predicate device. |
2
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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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
4
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)
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