(84 days)
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.
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.
Here's an analysis of the provided text regarding the ACON MDMA One Step Ecstasy Test Strip and Device, focusing on the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria. Instead, it presents the results of a comparison study against an FDA-cleared predicate device and Gas Chromatography-Mass Spectrometry (GC/MS). The performance is reported in terms of agreement (positive, negative, and overall). Based on the context of a 510(k) submission, the "acceptance criteria" can be inferred to be the achieved performance levels, which the FDA deemed substantially equivalent to the predicate.
Given this, the table of acceptance criteria and reported device performance is constructed as follows:
| Performance Metric | Inferred Acceptance Criteria (Based on Achieved Performance) | ACON MDMA One Step Ecstasy Test Strip | ACON MDMA One Step Ecstasy Test Device |
|---|---|---|---|
| Positive Agreement | 100% (with 95% CI of 96% ->99%) | 100% | 100% |
| Negative Agreement | 99% (with 95% CI of 96% ->99%) | 99% | 99% |
| Overall Agreement | 99% (with 95% CI of 98% ->99%) | 99% | 99% |
| Cutoff Concentration | 500 ng/mL | 500 ng/mL | 500 ng/mL |
| Qualitative Detection | Yes | Yes | Yes |
Note: The 95% Confidence Intervals are for the "FDA-cleared MDMA Ecstasy Test" but are used here as an indicator of the expected range for substantial equivalence. The document doesn't provide explicit, pre-defined numerical thresholds for acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 240 clinical urine specimens were used for the comparative evaluation against an FDA-cleared MDMA Ecstasy Test.
- For the more detailed breakdown against GC/MS: 93 MDMA positive urine samples and 147 MDMA negative urine samples were used for both the Strip and Device.
- Data Provenance: The document does not explicitly state the country of origin. The data is described as "clinical urine specimens," implying human-derived samples. It is retrospective, as the samples were collected and then tested. Nine of the positive samples were "derived from concentrated MDMA clinical specimens" to ensure representation within the +/- 25% cutoff range, while the rest were "true clinical specimens."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The ground truth for the test set was established primarily through Gas Chromatography-Mass Spectrometry (GC/MS). GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "experts" as human reviewers for ground truth establishment does not apply in the traditional sense for this study. GC/MS is considered the gold standard for confirmatory drug testing.
For negative samples, a "commercial MDMA rapid test kit" was used for initial screening, and approximately 10% of these negative samples were then confirmed by GC/MS.
4. Adjudication Method for the Test Set
The adjudication method wasn't a human-based consensus or 2+1/3+1 model. Instead, it was based on a direct comparison of the device's results against a gold standard (GC/MS) or a predicate device. Discrepancies (if any, though the reported agreement is very high) would be resolved by the GC/MS result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. This type of study typically involves multiple human readers evaluating cases with and without AI assistance to measure the impact of AI on human performance. The devices are diagnostic test kits, and the study focuses on their standalone performance rather than assisting human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The ACON MDMA One Step Ecstasy Test Strip and Device are designed to generate a visual, qualitative result (presence or absence of a colored line) without requiring an instrument. The study evaluates this standalone performance where the result is directly read from the device itself.
7. Type of Ground Truth Used
The primary ground truth used for establishing the accuracy of the device was Gas Chromatography-Mass Spectrometry (GC/MS). This is a highly accurate analytical method considered definitive for drug identification and quantification. In addition, an "FDA-cleared MDMA Ecstasy Test" served as a predicate for comparison.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or "training data" in the context of machine learning or algorithm development. This is because the ACON MDMA tests are immunochromatographic assays, which are based on chemical and biological principles (antibody-antigen interactions) rather than data-driven machine learning algorithms that typically require training data. The development of such a test involves reagent selection, optimization, and characterization rather than algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As noted above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development and validation of the immunochromatographic assay itself would be established through rigorous laboratory testing using known concentrations of MDMA and interferents, likely validated by GC/MS or other established analytical methods during the research and development phase before clinical evaluation.
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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
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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.
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- 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
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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 tocutoff | Cutoff to +25%cutoff | >+25% cutoff | ||
|---|---|---|---|---|---|
| ACONMDMAStrip | 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 tocutoff | Cutoff to +25%cutoff | >+25% cutoff | ||
|---|---|---|---|---|---|
| ACONMDMADevice | 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.
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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 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.
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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 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
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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
§ 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).