(79 days)
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central 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 is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL.
This document describes the Acro Rapid Phencyclidine Urine Test, a lateral flow immunoassay for detecting Phencyclidine (PCP) in human urine.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states the "cutoff of 25 ng/mL" for Phencyclidine detection. However, it does not contain a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or positive/negative predictive values. These are typically found in the clinical study section of a 510(k) submission, which is not included here. The document is primarily the FDA's clearance letter and the Indications for Use statement.
2. Sample size 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 about a test set sample size, data provenance, 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):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multicase (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 immunoassay for drug detection, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not applicable to its function, and no such study details are present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a lateral flow immunoassay that provides a visual qualitative result. It is not an algorithm, and its performance is inherently "standalone" in giving a preliminary result. However, the document emphasizes that "Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result" and that confirmation with GC/MS is needed. This implies a human interpretation step and subsequent confirmation. Therefore, while the initial test is standalone, it's not a fully automated diagnostic without human involvement in the overall clinical pathway. The document does not detail a study specifically on 'standalone' performance in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states, "In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This indicates that GC/MS analysis is the accepted "gold standard" or ground truth for confirming Phencyclidine presence.
8. The sample size for the training set:
The document does not provide any information about a training set sample size.
9. How the ground truth for the training set was established:
The document does not provide any information about a training set or how its ground truth was established. For an immunoassay, the "training" typically involves optimizing antibody-antigen reactions and cutoff concentrations, which would be validated against known concentrations (spiked samples) and confirmed clinical samples (with GC/MS as ground truth). However, these details are not in the provided text.
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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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 2006 MAY
Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 7th Street, Unit M Rancho Cucamonga, CA 91730
Re: K060353
Trade/Device Name: Acro Rapid Phencyclidine Urine Test Regulatory Class: Class II Product Code: LCM Dated: February 13, 2006 Received: February 17, 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, 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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Indications for Use
510(K) NUMBER (IF KNOWN) K060353
Device Name: Acro Rapid Phencyclidine Urine Test
Indications for Use
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central 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 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)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K060353 |
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| -------- | --------- |
N/A