(190 days)
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No
The description details a simple immunoassay (lateral flow test) which relies on chemical reactions for detection, not computational analysis or learning algorithms. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
This device is a diagnostic test for the detection of Benzoylecgonine, not a therapeutic device. It provides a qualitative result for laboratory use only and does not administer any treatment or therapy.
Yes
The device is a rapid urine test for the qualitative detection of Benzoylecgonine (cocaine metabolite), which is used to obtain a preliminary result for clinical consideration. This indicates its use in identifying a medical condition or risk factor.
No
The device description clearly states it is a "lateral flow, one-step immunoassay," which is a physical test strip, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative detection of Benzoylecgonine in human wipe". This involves testing a sample taken from the human body (a wipe) outside of the body (in vitro).
- Device Description: The description confirms it's a "lateral flow, one-step immunoassay," which is a common format for in vitro diagnostic tests.
- Intended User/Care Setting: It's intended for "laboratory use only," which is a typical setting for performing in vitro diagnostic tests.
The key characteristic of an IVD is that it's used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device fits that description by testing a human wipe sample for the presence of Benzoylecgonine.
N/A
Intended Use / Indications for Use
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 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) anchiate is preferred.
Product codes
DIO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with intertwined elements.
Public Health Service
MAY 5 2006 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
Re: K053035
Trade/Device Name: Acro Rapid Benzoylecgonine (Cocaine) Urine Test Regulation Number: 21 CFR§862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: January 15, 2006 Received: March 6, 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, Trug, 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 af 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 sybstantial 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 not 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 tollar de (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G.
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
2
Premarket Notification
Acro Biotech LLC. Acro Rapid Benzoylecgonine (Cocaine) Urine Test
II. FDA INDICATIONS FOR USE FORM
510(K) NUMBER (IF KNOWN): K053035
Device Name: Acro Rapid Benzoylecgonine (Cocaine)Urine Test
Indications for Use
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 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) anchiate 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 Vitao Diagnostic Device Evaluation and Safety
510(k) K053035
Acro Biotech, LLC., 9500 7th Street, Unit M, Rancho Cucamonga CA 91730 Tel: 909-466-6892, Fax: 909-466-6857