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.

Device Description

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.

AI/ML Overview

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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 9 2006

Mr. Greg Liang Acro Biotech, LLC 9500 7th Street, Unit M Rancho Cucamonga, CA 91730

Re: K053032

Trade/Device Name: Acro Biotech LLC Rapid Amphetamine Urine Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II, Product Code: DKZ Dated: January 7, 2006 Received: January 9, 2006

Dear Mr. Liang:

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 yours,

Alberto Gutierrez Ph.D.

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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CONFIDENTIAL

Premarket Notification Acro Rapid Amphetamine Urine Test

II. FDA INDICATIONS FOR USE FORM 510(K) NUMBER (IF KNOWN): K053032

Acro Rapid Amphetamine Urine Test Device Name:

Indications for Use

Prescription Use __ メ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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)

Carol Benson

K053032

Regulation Number and Section

§ 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).