(175 days)
Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.
The provided text contains information about the Acro Biotech Rapid MDMA Urine Test and its FDA 510(k) clearance. However, it does not include the detailed study information required to fully answer your request regarding acceptance criteria and performance data. The document is an FDA clearance letter and an Indications For Use form, focusing on regulatory approval rather than a comprehensive study report.
Therefore, I cannot provide a complete answer with all the requested details. However, I can extract what is present and then indicate what information is missing.
Information Extracted from the Provided Text:
- Device Name: Acro Biotech Rapid MDMA Urine Test
- Intended Use: Qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. It is a lateral flow, rapid immunoassay for laboratory use only.
- Result Type: Visual qualitative result.
- Preliminary Nature: Provides only a preliminary result; clinical consideration and professional judgment are needed. Confirmation with a more specific alternate chemical method (preferably GC/MS) is required for positive results.
Attempt to Answer Based on Limited Information (with significant gaps):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative Detection of MDMA in urine at a cutoff of 500 ng/mL | Not provided in the document. |
| Intended for laboratory use only. | The device is cleared for laboratory use. |
| Provides a preliminary result requiring confirmation. | The device provides a preliminary result and states confirmation with GC/MS is preferred. |
| (Other performance metrics such as sensitivity, specificity, accuracy, precision, cross-reactivity, interference, etc., would typically be part of acceptance criteria for this type of device, but are not detailed in this document). | Not provided in the document. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. For a drug test, the ground truth is typically established by a reference method like GC/MS, not expert consensus on interpretation. However, the document does not detail this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. For a laboratory immunoassay, adjudication by human experts in the typical sense for imaging or clinical diagnosis is not usually conducted. The comparison is against a reference method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a rapid immunoassay, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. As an immunoassay, its performance is evaluated in a "standalone" manner against a reference method (GC/MS). The document, however, does not provide performance results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies that Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred method for confirmation, strongly suggesting this would be the ground truth used in performance studies.
8. The sample size for the training set
- Not applicable/Not provided. This is an immunoassay, not a machine-learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
Summary of Missing Information:
The provided document is a regulatory approval letter and indications for use. It does not contain:
- Specific performance metrics (sensitivity, specificity, accuracy, precision, cross-reactivity, interference studies) for the device.
- The sample sizes used in any validation studies.
- Details on how ground truth was established by the manufacturer's internal studies (though it implies GC/MS would be used for confirmation outside the scope of the rapid test).
- Any information regarding the design (prospective/retrospective), data provenance, or geographical origin of samples for performance studies.
- Any information related to multi-reader studies or AI assistance, as this is a qualitative immunoassay.
To obtain the detailed study information, one would typically need to consult the full 510(k) summary or submission dossier, which is publicly available on the FDA website for cleared devices but not included in this excerpt.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gregory Lee, Ph.D. Consultant Acro Biotech LLC 9500 7th Street Unit M Rancho Cucamonga, CA 91730
AUG - 7 2006
Re: K060355
Trade/Device Name: Acro Biotech Rapid MDMA Urine Test Regulation Number: 21 CFR§862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC Dated: June 30, 2006 Received: July 3, 2006
Dear Dr. Lee:
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 G
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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FDA INDICTAIONS FOR USE FORM
510(K) NUMBER (IF KNOWN)_ ٢٠٥٠ 03 5
Device Name: Acro Rapid MDMA Urine Test
Indications for Use
Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Prescription Use >< (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Jivision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
§ 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).