(231 days)
Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 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.
A lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine.
This is a FDA 510(k) premarket notification for the Acro Rapid Opiate Urine Test, a device used for the qualitative detection of Opiate in human urine. The document is a letter from the FDA to Acro Biotech LLC, indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document, being an FDA 510(k) clearance letter, primarily establishes substantial equivalence without detailing specific acceptance criteria or performance metrics in a tabular format within the available text.
However, the "Indications for Use" section mentions:
- Qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL.
- The test is used to obtain a visual qualitative result and is intended for laboratory use only.
To infer performance, we can deduce that the device must demonstrate sufficient accuracy (sensitivity and specificity) around this cutoff for qualitative detection. Since this document declares substantial equivalence, it implies that the device's performance is comparable to or better than existing legally marketed predicate devices for the same intended use.
Without the actual study report or further sections of the 510(k) submission, specific reported device performance metrics like sensitivity, specificity, accuracy, or repeatability at the 2000 ng/mL cutoff are not quantifiable from the given text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample size used for the test set, the country of origin of the data, or whether the study was 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)
The document does not provide any information regarding the number of experts used to establish the ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for the test set.
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 Opiate Urine Test," described as a "lateral flow, one-step immunoassay." This type of device is a diagnostic test kit that provides a direct visual qualitative result, not an AI-powered image analysis or diagnostic tool that would involve "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a standalone test kit. Its performance is inherently "algorithm only" in the sense that it produces a direct visual qualitative result based on its chemical/immunological reactivity. There isn't an "algorithm" in the computational sense applied to interpret a human observation; rather, the device itself provides the result for interpretation. So, yes, its performance would be assessed as a standalone device, but not in the context of a computational algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "Indications for Use" 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 strongly indicates that Gas Chromatography/ Mass Spectroscopy (GC/MS) is the preferred method for establishing the ground truth (the reference standard or true positive/negative for Opiate presence in urine).
8. The sample size for the training set
The document does not provide any information regarding the sample size for the training set. This context is less relevant for a lateral flow immunoassay compared to machine learning models, as these devices are designed and optimized based on chemical principles and reagent characteristics rather than being "trained" on data in the same way an AI model is.
9. How the ground truth for the training set was established
The document does not provide any information on how ground truth for a "training set" (if such a concept is applied in this context of immunoassay development) was established. As mentioned above, for this type of device, development involves chemical formulation and optimization, not data-driven "training" as in AI. However, if any reference samples were used during development, it is highly probable that GC/MS would have been used to confirm the presence and concentration of opiates in those samples.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 7th Street # Unit M Rancho Cucamonga CA 91730
JUN 15 2006
Re: K053037 Trade/Device Name: Acro Raid Opiate Urine Test Regulation Number: 21 CFR$862.3650 Regulation Name: . Opiate test system Regulatory Class: Class II Product Code: DJG Dated: May 10, 2006 Received: May 11, 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 udicetions for use stated in the enclosure) to legally marketed predicate devices marketed in intereste commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonstits, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Orug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, inst roce 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 Devistm
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 tollit the number (800) 638-2041 or (301) 443-6597 or at its Internet address. http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Albert Sutt
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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Acro Biotech LLC. Acro Rapid Opiate Urine Test
FDA INDICATIONS FOR USE FORM II.
510(K) NUMBER (IF KNOWN) K053037
Device Name:
Indications for Use
Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 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 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) |
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| Acro Biotech, LLC., 9500 7th Street #Unit M, Rancho Cucamonga CA 91730 |
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| Tel: 909-466-6892, Fax: 909-466-6857 |
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| Office of In Vitro Diagnostic Device Evaluation and Safety |
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| V054037 |
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).