ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 by ACRO BIOTECH LLC.

Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 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.

Device Description

Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Acro Rapid (THC) Marijuana Urine Test, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details on ground truth establishment and expert qualifications for those sets.
Information on MRMC studies or standalone algorithm performance.
Details regarding the training set.

The document only states the intended use of the device and its regulatory classification. It confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing Acro Biotech LLC to market it.

Below is information that can be extracted from the provided text, and an explanation of why other requested details are not present.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied from Indications for Use): Qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL. The device must produce a "preliminary positive result" when THC is present at or above this cutoff, and a "negative result" when below.
Reported Device Performance: Not provided in this document. The FDA letter states that the device has been found "substantially equivalent" to predicate devices, implying its performance meets acceptable standards, but specific performance metrics (e.g., sensitivity, specificity, accuracy) are not listed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document is a regulatory clearance letter, not a study report.

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. The "ground truth" for drug tests like this typically involves a more specific analytical method, such as GC/MS. The document mentions: "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 GC/MS is the reference method, but details on how this was applied in a test set, including expert involvement, are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are typically relevant for subjective interpretations (like medical imaging), not for qualitative chemical tests where a reference method (GC/MS in this case) provides the definitive answer.

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/Not provided. This device is a rapid urine test for THC, not an AI-based system or an imaging device requiring human reader interpretation in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a rapid immunoassay device, not an algorithm. The "standalone" performance would refer to the device's accuracy in detecting THC against a reference method (GC/MS), but specific study details are not in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Chemical Analysis: The document states, "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 indicates that GC/MS is the 'gold standard' or ground truth method for confirmation.

8. The sample size for the training set

Not applicable/Not provided. This is a chemical immunoassay, not a machine learning model, so there is no "training set" in the context of AI.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, there is no "training set" in the context of this device.

In summary: The provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence but does not detail the specific performance study results, methodologies, or data characteristics (like sample size, provenance, expert details) that would typically be found in a study report. For that level of detail, one would need to refer to the actual 510(k) submission itself or related performance studies if they were made public.

Summary

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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 depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 2006

Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 760 Street Unit M Rancho Cucamonga, CA 91730

Re: K053034

Trade/Device Name: Acro Rapid (THC) Marijuana Urine Test Regulation Number: 21 CFR§862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: April 10, 2006 Received: April 10, 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 yours,

Alberto Gutierrez

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 INDICATIONS FOR USE FORM II.

510(K) NUMBER (IF KNOWN) K053034

Acro Rapid THC (Marijuana) Urine Test Device Name:

Indications for Use

Prescription Use X (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 C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053034

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).