(58 days)
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No
The device description details a lateral flow immunochromatographic assay that provides a visual result based on antigen-antibody reactions, without any mention of computational analysis or algorithms.
No.
The device is a rapid test for detecting Buprenorphine in urine, intended for diagnostic purposes (drug compliance), not for therapeutic treatment.
Yes
The device is intended for the qualitative detection of Buprenorphine in human urine to assist in the determination of drug compliance, which is a diagnostic purpose.
No
The device description clearly states it is a "rapid chromatographic immunoassay" and a "competitive binding, lateral flow immunochromatographic assay," which are physical test strips/devices that utilize chemical reactions to detect substances. It also mentions "membrane wicking" and the appearance of "colored-line[s]," indicating a physical process, not a software-only function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Buprenorphine in human urine" and is "intended for use by healthcare professionals... to assist in the determination of drug compliance." This involves testing a sample taken from the human body (urine) to provide information about a person's health status (presence of Buprenorphine).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "antigen-antibody immunochemistry" to detect a substance in a "urine sample." This is a common characteristic of IVD devices.
- Performance Studies: The document describes clinical evaluations using "clinical urine specimens" and comparisons to other tests and a confirmatory method (LC/MS), which are standard practices for validating the performance of IVD devices.
The definition of an In Vitro Diagnostic device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this device is for drug compliance rather than diagnosing a disease, it is still performing a test on a sample taken from the body to provide information about a person's physiological state, which falls under the broader scope of IVD devices.
N/A
Intended Use / Indications for Use
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result atchuid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory mcthods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DIG, DJG
Device Description
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Bupuprenorphine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Buprenorphine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonial antibody to selectively detect elevated levels of Buprenorphine in urine at a cutoff concentration of 10 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Buprenorphine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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
healthcare professionals including professionals at point-of-care sites
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A clinical evaluation was conducted using 226 clinical urine specimens including approximately 10% of the specimens containing Buprenorphine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON BUP One Step Buprenorphine Test Strip and ACON BUP One Step Buprenorphine Test Device with a FDAcleared Buprenorphine test; as well as compared against data obtained from the customary Liquid Chromatography/Mass Spectrometry analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical evaluation was conducted using 226 clinical urine specimens.
ACON BUP One Step Buprenorphine Test Strip versus a FDA-cleared BUP Test:
Positive Agreement: 54 / 64 = 84% (73% - 92%)
Negative Agreement: 161 / 162 = 99% (97% - 99%)
Overall Agreement: 215 / 226 = 95% (91% - 98%)
ACON BUP One Step Buprenorphine Test Device versus a FDA-cleared BUP Test:
Positive Agreement: 54 / 64 = 84% (73% - 92%)
Negative Agreement: 161 / 162 = 99% (97% - 99%)
Overall Agreement: 215 / 226 = 95% (91% - 98%)
ACON BUP One Step Buprenorphine Test Strip versus data obtained with LC/MS at the cutoff concentration of 10 ng/mL:
Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)
ACON BUP One Step Buprenorphine Test Device versus LC/MS:
Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)
The performance characteristics were also verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: 84%
Negative Agreement: 99%
Overall Agreement: 95%
Total Agreement with LC/MS: 99.6%
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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5. 510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is K060466
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
February 21, 2006
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® BUP One Step Buprenorphine Test Strip ACON® BUP One Step Buprenorphine Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Buprenorphine in urine.
Regulation Name:
Buprenorphine test system.
Product Code:
DIG
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Classification Number:
21 CFR, 862.3650
Device Classification:
The Buprenorphine test systems have been classified as Class II devices with moderate complexity. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably LC/MS analysis.
Intended Use:
The ACON BUP One Step Buprenorphine Test Strip and ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in urine at a cutoff concentration of 10 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably LC/MS analysis. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.
Description:
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Buprenorphine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Buprenorphine in urine at a cutoff concentration of 10 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Buprenorphine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 226 clinical urine specimens including approximately 10% of the specimens containing Buprenorphine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON BUP One Step Buprenorphine Test Strip and ACON BUP One Step Buprenorphine Test Device with a FDAcleared Buprenorphine test; as well as compared against data obtained from the customary
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Liquid Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:
ACON BUP One Step Buprenorphine Test Strip versus a FDA-cleared BUP Test:
Positive Agreement: 54 / 64 = 84% (73% - 92%)* Negative Agreement: 161 / 162 = 99% (97% - 99%)* Overall Agreement: 215 / 226 = 95% (91% - 98%)* * 95% confidence intervals
ACON BUP One Step Buprenorphine Test Device versus a FDA-cleared BUP Test:
Positive Agreement: 54 / 64 = 84% (73% - 92%)* Negative Agreement: 161 / 162 = 99% (97% - 99%)* Overall Agreement: 215 / 226 = 95% (91% - 98%)* * 95% confidence intervals
ACON BUP One Step Buprenorphine Test Strip versus data obtained with LC/MS at the cutoff concentration of 10 ng/mL:
ACON BUP One Step Buprenorphine Test Strip versus LC/MS.
| Specimen Cutoff Range by LC/MS Data | ||||||||
|---|---|---|---|---|---|---|---|---|
| Negative | +25% Cutoff | % Agreement | ||||||
| ACON BUP | ||||||||
| Test Strip | Positive | 0 | 0 | 0 | 5 | 50 | 98% (55/56) | |
| (90%-99%)* | ||||||||
| Negative | 150 | 15 | 5 | 1 | 0 | >99% (170/170) | ||
| (98%-100%)** |
Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)* * Denotes 95% confidence interval.
** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval.
ACON BUP One Step Buprenorphine Test Device versus LC/MS.
| Specimen Cutoff Range by LC/MS Data | ||||||
|---|---|---|---|---|---|---|
| Negative | +25% Cutoff | % Agreement | ||||
| ACON BUP | ||||||
| Test Device | Positive | 0 | 0 | 0 | 50 | 98% (55/56) |
| (90% - 99%)* | ||||||
| Negative | 150 | 15 | 5 | 1 | 0 |
Total agreement with LC/MS: 225/226 = 99.6% (98% - 99%)*
- Denotes 95% confidence interval.
** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval.
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Performance Characteristics and Other information:
The performance characteristics of the ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.
Conclusion:
These clinical studies demonstrated substantial equivalency on performance between the ACON BUP One Step Buprenorphine Test Strip, the ACON BUP One Step Buprenorphine Test Device and a FDA-cleared Buprenorphine test with the same Buprenorphine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Buprenorphine at a concentration of 10 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
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Image /page/4/Picture/1 description: The image shows a black and white emblem. The emblem features a stylized bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text, which appears to be the name of an organization or agency. The overall design is circular and professional.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
APR 2 1 2006
Re: K060466
Trade/Device Name: ACON BUP One Step Buprenorphine Test Strip ACON BUP One Step Buprenorphine Test Device Regulation Number: 21 CFR§862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: February 21, 2006 Received: February 22, 2006
Dear Dr. Tung:
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, Orug 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, EDA 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 af 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 pratis 1 requirements as set forth in the quality systems (QS) regulation (21 CFR Pris B20).
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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 yours,
Alberto Gutt
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): Ko 60466)
Device Name: ACON BUP One Step Buprenorphine Test Strip
ACON BUP One Step Buprenorphine Test Device
Indications for Use:
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result atchuid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory mcthods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use X (Part 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)
A
In Vitro Disanostic Dovice
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