(105 days)
Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only preliminary results. 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 Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.
The provided text is a 510(k) clearance letter from the FDA for the Acro Biotech LLC Rapid Amphetamine Urine Test. It does not contain the acceptance criteria or a detailed study description with specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for ground truth, as would be expected for a comprehensive study report.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided in the 510(k) submission, which would have included performance data, but that specific data is not detailed in this document.
Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail. The FDA letter is a regulatory clearance document, not a scientific study report.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. In the context of a 510(k), acceptance criteria for performance would typically be defined relative to the predicate device's performance, but the specific metrics are not present here.
- Reported Device Performance: Not reported in the provided text. The letter only states that the device was found "substantially equivalent."
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 (Test Set): Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text.
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)
- Number of Experts/Qualifications: Not mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned in the provided text.
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
- This device is an "Acro Rapid Amphetamine Urine Test," which is a rapid immunoassay for detecting amphetamine in urine. It is a diagnostic test kit, not an AI-based system or an imaging device requiring human reader interpretation in the same way. Therefore, an MRMC study with human readers and AI assistance would not be applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device described is a "lateral flow, rapid immunoassay" for qualitative detection. This is essentially a "standalone" test in that it produces a visual result without direct human interpretation of complex images or algorithms. However, the "Indications for Use" states: "This assay provides only preliminary results. 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." This implies that while the initial test is standalone, human judgment and further confirmatory testing are critical for clinical decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The Indications for Use section mentions that "Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred" for confirming results. It is highly probable that GC/MS would have been used as the ground truth for validating the rapid immunoassay's performance in the 510(k) study. GC/MS is a highly accurate and specific analytical method for drug detection.
8. The sample size for the training set
- Sample Size (Training Set): Not mentioned in the provided text. Rapid immunoassays typically don't have "training sets" in the same way machine learning models do. Their development involves optimizing antibodies and test parameters, and performance is then validated on clinical samples.
9. How the ground truth for the training set was established
- See point 8. For typical immunoassay development and validation, GC/MS (or a similarly gold-standard analytical method) would be used to establish the true presence or absence of the analyte (amphetamine) in samples used for both development and validation.
To obtain the detailed information requested, one would need to review the specific 510(k) submission (K053032) from Acro Biotech LLC to the FDA, which is a much more extensive document than this clearance letter.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).