(84 days)
ACON® MDMA One Step Ecstasy Test Strip, ACON® MDMA One Step Ecstasy Test Device
Not Found
No
The device description details a simple lateral flow immunoassay that provides a visual result based on antigen-antibody binding, without any mention of computational analysis, algorithms, or learning processes.
No
The device is a diagnostic tool used to detect the presence of MDMA in urine; it does not provide any treatment or therapy.
Yes
The device is described as a "rapid chromatographic immunoassay for the qualitative detection of MDMA in urine," which directly indicates its function is to detect a substance as a means of diagnosis.
No
The device is a physical test strip/device that uses immunochromatographic assays to detect MDMA in urine. It is not software-based.
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 MDMA in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of MDMA).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "antigen-antibody immunochemistry" to detect MDMA in a urine sample. This is a classic description of an in vitro diagnostic test.
- Sample Type: The test uses urine, which is a biological specimen collected from a patient.
- Purpose: The purpose is to detect the presence of a substance (MDMA) in the sample, which is a diagnostic function.
The fact that it's a rapid, qualitative test performed without an instrument and intended for healthcare professionals at point-of-care sites further supports its classification as an IVD, specifically a point-of-care IVD.
N/A
Intended Use / Indications for Use
The ACON® MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic immunoassays for the qualitative detection of MDMA in urine at a cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
Product codes
LAF
Device Description
The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of MDMA 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 MDMA in urine at a cutoff concentration of 500 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 MDMA 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
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
healthcare professionals including professionals at point-of-care sites.
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
A clinical evaluation was conducted using 240 clinical urine specimens including approximately 12% of the MDMA containing specimens with MDMA concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON® MDMA One Step Ecstasy Test Strip and ACON® MDMA One Step Ecstasy Test Device with a FDA-cleared MDMA Ecstasy Test; as well as comparing against data obtained from the customary Gas Chromatography-Mass Spectrometry analysis.
ACON MDMA One Step Ecstasy Test Strips were tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS.
ACON MDMA One Step Ecstasy Test Devices were also tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical evaluation (accuracy study) with 240 clinical urine specimens.
Comparison of ACON MDMA One Step Ecstasy Test Strip versus FDA-cleared MDMA Test:
Positive Agreement: 90 / 90 = 100% (96% - >99% confidence interval)
Negative Agreement: 149 / 150 = 99% (96% - >99% confidence interval)
Overall Agreement: 239/ 240 = 99% (98% - >99% confidence interval)
Comparison of ACON MDMA One Step Ecstasy Test Device versus FDA-cleared MDMA Test:
Positive Agreement: 90 / 90 = 100% (96% - >99% confidence interval)
Negative Agreement: 149 / 150 = 99% (96% - >99% confidence interval)
Overall Agreement: 1177/ 136 = 99% (98% - 99% confidence interval)
Results for ACON MDMA One Step Ecstasy Test Strip:
Positive (MDMA concentration >+25% cutoff): 82
Negative (MDMA concentration Negative): 147
Results for ACON MDMA One Step Ecstasy Test Device:
Positive (MDMA concentration -25% cutoff to +25% cutoff): 82
Negative (MDMA concentration Negative): 147
Negative (MDMA concentration -25% cutoff to
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
OCT 2 8 2002
510(k) SUMMARY 8.
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 K022589.
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
July 30, 2002
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® MDMA One Step Ecstasy Test Strip ACON® MDMA One Step Ecstasy Test Device
Common Name:
Immunochromatographic test for the qualitative detection of MDMA in urine.
Device Classification:
The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are similar to other FDA-cleared devices for the qualitative detection of MDMA in urine specimens. These tests are used to provide a preliminary analytical
1
result. MDMA test systems have been classified as Class II devices with moderate complexity.
Classification Name:
Methylenedioxymetamphetamines (MDMA) test system
Intended Use:
The ACON® MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic immunoassays for the qualitative detection of MDMA in urine at a cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
Description:
The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of MDMA 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 MDMA in urine at a cutoff concentration of 500 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 MDMA 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.
Comparison to a Predicate Device:
A comparison of the features of the ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device versus a FDA-cleared MDMA (Ecstasy) Test is shown below:
- . Both tests are assays intended for the qualitative detection of MDMA 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 MDMA with a visual, qualitative end result.
2
- 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 MDMA concentration of 500 ng/mL. ●
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 240 clinical urine specimens including approximately 12% of the MDMA containing specimens with MDMA concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON® MDMA One Step Ecstasy Test Strip and ACON® MDMA One Step Ecstasy Test Device with a FDA-cleared MDMA Ecstasy Test; as well as comparing against data obtained from the customary Gas ChromatographyMass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:
A CON MDMA One Step Ecstasy Test Strip versus FDA-cleared MDMA Test:
Positive Agreement: 90 / 90 = 100% (96% - >99%) Negative Agreement: 149 / 150 = 99% (96% - >99%) Overall Agreement: 239/ 240 = 99% (98% - >99%*)
- Denotes 95% Confidence Intervals.
ACON MDMA One Step Ecstasy Test Device versus FDA-cleared MDMA Test:
Positive Agreement: 90 / 90 = 100% (96% - >99%) Negative Agreement: 149 / 150 = 99% (96% - >99%) Regative Pigroement: 1177 136 = 99% (98% - 99% (98% - 99%*)
- Denotes 95% Confidence Intervals
3
ACON MDMA One Step Ecstasy Test Strips were tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated.
| | | Negative | -25% cutoff to
cutoff | Cutoff to +25%
cutoff | >+25% cutoff |
|-----------------------|----------|----------|--------------------------|--------------------------|--------------|
| ACON
MDMA
Strip | Positive | | | | 82 |
| | Negative | 147 | | | |
ACON MDMA One Step Ecstasy Test Devices were also tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated.
| | | Negative | -25% cutoff to
cutoff | Cutoff to +25%
cutoff | >+25% cutoff |
|------------------------|----------|----------|--------------------------|--------------------------|--------------|
| ACON
MDMA
Device | Positive | 0 | 3 | 6 | 82 |
| | Negative | 147 | 2 | 0 | 0 |
Conclusion:
These clinical studies demonstrated substantial equivalency on performance between the ACON MDMA One Step Ecstasy Test Strip, ACON MDMA One Step Ecstasy Test Device and a FDA-cleared Ecstasy Test, which is being marketed in the United States. It is also demonstrated that these tests are safe and effective in qualitatively detecting MDMA at a concentration of 500 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2002
Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
K022589 Re:
Trade/Device Name: ACON® MDMA One Step Ecstasy Test Strip ACON® MDMA One Step Ecstasy Test Device Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: August 1, 2002 Received: August 5, 2002
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. Iisting 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.
5
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 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/cdrb/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
6
10. INDICATIONS FOR USE
510(k) Number:
Device Name: ACON® MDMA One Step Ecstasy Test Strip
ACON® MDMA One Step Ecstasy Test Device
Indications for Use:
The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic the immunoassays detection Methylenedioxymethamphetamine (MDMA) in human urine at a designated cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
(Per 21 CFR 801.109)
Or
Over-The-Counter Use
Tonlough
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number