(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.
§ 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).