(165 days)
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Not Found
No
The summary describes a lateral flow immunoassay for qualitative drug detection, which is a traditional chemical assay method and does not mention any AI or ML components.
No
The device is a rapid immunoassay for qualitative detection of Oxazepam in urine, used for diagnostic purposes (obtaining a preliminary result for drug testing), not for treating or preventing disease.
Yes
Explanation: The device is an immunoassay that provides a qualitative result for a specific substance (Oxazepam) in human urine, which is used to assist in diagnosis (e.g., drug testing).
No
The device is described as a "lateral flow, rapid immunoassay" which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a test performed on a human sample (urine) to detect a substance (Benzodiazepine/Oxazepam) for diagnostic purposes (obtaining a preliminary result for drug testing).
- Sample Type: It uses a biological sample taken from the human body (urine).
- Purpose: It's designed to provide information about the presence of a substance in the sample, which is a key characteristic of IVDs.
- Care Setting: While it's for laboratory use, this is a common setting for IVD testing.
The description aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine 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 mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Product codes
JXM
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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§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a stylized black and white drawing of an eagle. The eagle is depicted with three parallel lines forming its body and wings, giving it a modern and abstract appearance. The head of the eagle is also stylized, with a sharp beak and a suggestion of an eye.
Public Heath Searce
JUL 2 8 2006
Food and Dr. a Administras 2098 Galber Road Rockville MD 20850
Dr. Gregory Lee Acro Biotech. LLC. 9500 7" Street Unit M Rancho Cucamonga, CA 91730
Re: K060354 Trade/Device Name: Acro Rapid Benzodiazepine Urine Test Regulation Number: 21 CFR8862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: June 12, 2006 Received: July 14, 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,
Albert G. A.
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
510(K) NUMBER (IF KNOWN) K060354
Acro Rapid Benzodiazepine Urine Test Device Name:
Indications for Use
Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine 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 mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
acting
216354