(66 days)
LifeSign Status DSM MTD One-Step Methadone Test, Enebig. Das Chromatography/Mass Spectrometry
No
The device description details a lateral flow immunochromatographic assay that relies on antigen-antibody reactions and visual interpretation of colored lines. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No
This device is a diagnostic tool used to detect methadone in urine, not to treat or alleviate a medical condition.
Yes
The device detects methadone in urine, which is a qualitative assessment used to identify the presence of a substance, thereby aiding in diagnosis or monitoring.
No
The device is a rapid chromatographic immunoassay test strip/device, which is a physical diagnostic product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of methadone in urine". This indicates that the device is used to examine a specimen (urine) taken from the human body to provide information about a physiological state (presence of methadone).
- 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 classic description of an in vitro diagnostic test.
- Specimen Type: The device uses urine, which is a specimen derived from the human body.
- Purpose: The purpose is to detect the presence of methadone, which is a substance that can indicate drug use or treatment, providing information about the individual's health status.
The definition of an In Vitro Diagnostic device generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. This device fits that description.
N/A
Intended Use / Indications for Use
The ACON® MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.
Product codes
DJR
Device Description
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of methadone in urine at a cut-off concentration of 300 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 methadone 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 will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and healthcare professional use.
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
Not Found
Summary of Performance Studies
Accuracy: A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with methadone concentrations at -25% cut-off range. This evaluation samples with memations concentrations at 25% on. On . Step Methadone Test Strip and Test Device with LifeSign Status DSM MTD One-Step Methadone Test; as well as against data Dovio with Enebig. Das Chromatography/Mass Spectrometry analysis.
Key Metrics
ACON MTD One Step Methadone Test Strip versus LifeSign Status DSTM MTD One- Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%)
Negative Agreement: 168 / 168 = 100% (98% - 100%)
Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%)
Negative Agreement: 168 / 168 = 100% (98% - 100%)
Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Strip versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%)
Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%)
Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
ACON MTD One-Step Methadone Test Device versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%)
Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%)
Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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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OCT 1 5 2001
8. SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS
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 Kolla595 - Color September i
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date: August 6, 2001
Contact Person: Edward Tung, Ph.D.
Product Names:
ACON® MTD One Step Methadone Test Strip
ACON® MTD One Step Methadone Test Device
Common Name:
Immunochromatographic test for the qualitative detection of methadone in urine
Device Classification:
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are similar to other FDA-cleared devices for the qualitative detection of methadone in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3620). Methadone test systems have been classified as Class II devices with moderate complexity.
Classification Name:
Methadone test system
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Intended Use:
The ACON® MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.
Description:
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of methadone in urine at a cut-off concentration of 300 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 methadone 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 will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Predicate Device:
LifeSign Status DSTM MTD One-Step Methadone Test
510(k) Number: K991080
Comparison to a Predicate Device:
A comparison of the features of the ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test is shown below:
- Both tests are assays intended for the qualitative detection of methadone in urine samples. ●
- Both tests are intended as a screening method that provides a preliminary analytical test result. .
- Both tests are immunochromatographic, lateral flow assays for the rapid detection of ● methadone with a visual, qualitative end result.
- Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody ● interactions to indicate a positive or negative result.
- . Both tests have a cut-off methadone concentration of 300 ng/mL.
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Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with methadone concentrations at -25% cut-off range. This evaluation samples with memations concentrations at 25% on. On . Step Methadone Test Strip and Test Device with LifeSign Status DSM MTD One-Step Methadone Test; as well as against data Dovio with Enebig. Das Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:
ACON MTD One Step Methadone Test Strip versus LifeSign Status DSTM MTD One- Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%) Negative Agreement: 168 / 168 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%) Negative Agreement: 168 / 168 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Strip versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
ACON MTD One-Step Methadone Test Device versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
3
Conclusion:
These clinical studies demonstrate the substantial equivalency between the ACON MTD One Step Methadone Test Strip, ACON MTD One Step Methadone Test Device and the LifeSign Status Monadone Test Datpy Freeddone Test, which has already being marketed in the United States. It is Do - HITD One Diep Sizease tests are safe and effective in detecting methadone at a concentration also connemally demonstrated that these tests are suitable for healthcare professionals and professional point-of-care use.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 5 2001
Edward Tung, Ph.D. Director of Regulatory Affair ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
K012595 Re:
Trade/Device Name: ACON® MTD One Step Methadone Test Strip and ACON® MTD One Step Methadone Test Device Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: August 8, 2001 Received: August 10, 2001
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, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 10.
510(k) Number:
Kolasgs
Device Name: ACON® MTD One Step Methadone Test Strip
ACON® MTD One Step Methadone Test Device
The ACON MTD One Step Methadone Test Strip and ACON MTD One Indications for Use: Step Methadone Test Device are rapid chromatographic immunoassays Blog Moundone in etection of Methadone in human urine at a cut-off They are intended for healthcare concentration of 300 ng/mL. professionals and professional point-of-care use.
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Kevia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012595
Or
Over-The-Counter Use_
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