(20 days)
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No
The summary describes a standard immunoassay for drug detection in urine, with no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML devices.
No
The device is an immunoassay for detecting substances in urine, which is a diagnostic tool, not a therapeutic one. It assists in screening and diagnosis, but does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" states that the device is an immunoassay for the qualitative detection of substances in human urine "to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs." The mention of "diagnosis of clinical symptoms" indicates a diagnostic purpose.
No
The device is an immunoassay for detecting substances in human urine, which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "Immunoassay for the qualitative detection of barbiturates, benzodiazepine, and/or their metabolites in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs of abuse).
- Anatomical Site: The anatomical site is "human urine," which is a biological sample.
- Purpose: The purpose is to "assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs." This aligns with the definition of an IVD, which is used to diagnose, monitor, or screen for diseases or conditions.
The information provided strongly indicates that this device is designed to be used in a laboratory or clinical setting to analyze a biological sample for diagnostic or screening purposes, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of barbiturates, benzodiazepine, and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.
Product codes
DIS, JXM, DJR
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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional Use: X Prescription Use: X
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
APR 1 5 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jemo Kang, Ph.D. President Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905
Re: K991084 Trade Name: AccuSign® DOA3 (BAR/BZO/MTD) Regulatory Class: II Product Code: DIS, JXM, DJR Dated: March 22, 1999 Received: March 26, 1999
Dear Dr. Kang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K991084 510(k) Number (if known): __
hce Name:___AccuSign® DOA3 (BAR/BZO/MTD)
Indications For Use:
Immunoassay for the qualitative detection of barbiturates, benzodiazepine, and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991084
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ı i
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:_X Prescription Use:_X (Per 21 CFR 801.109)
OR
Over The Counter Use: _
(Optional Format 1-2-96)