(20 days)
Immunoassay for the qualitative detection of benzodiazepines 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 drug.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "AccuSign® BZO", an immunoassay for detecting benzodiazepines in human urine. This document confirms the device's substantial equivalence to a legally marketed predicate device and does not contain the detailed study information typically found in a clinical trial report or a submission summary. Therefore, based only on the provided text, a comprehensive answer to your request cannot be fully generated as much of the requested information (acceptance criteria, specific performance data, sample sizes, expert qualifications, etc.) is not present.
However, I can extract what little can be inferred from the document. The general nature of a 510(k) submission for an in vitro diagnostic device implies certain aspects.
Here's an assessment based on the provided text and general knowledge of 510(k) submissions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or limits of detection. The letter merely states that the FDA "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."
Therefore, no table can be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts used or their qualifications. For an immunoassay, the "ground truth" would typically be established by a reference method (e.g., GC/MS or LC/MS) rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method. For assays, the "adjudication" is typically a comparison to the reference method result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
MRMC studies are typically for image-based diagnostic devices where human interpretation is involved. The AccuSign® BZO is an immunoassay for qualitative detection, which usually gives a discrete positive/negative result. Therefore, it is highly unlikely an MRMC study was conducted or would be relevant for this type of device. The document does not mention any MRMC study.
6. Standalone (Algorithm Only) Performance:
This device is an immunoassay, which provides a direct chemical or biological result rather than an algorithm processing data. Therefore, the concept of "standalone (algorithm only)" performance, as typically applied to AI/ML devices, is not applicable here. The device itself is "standalone" in that it provides a result without subsequent human interpretation for its primary function. The document does not explicitly state "standalone performance" in the context of an algorithm.
7. Type of Ground Truth Used:
While not explicitly stated, for an immunoassay detecting drugs of abuse, the ground truth would almost certainly be established by confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These methods are considered the gold standard for drug detection and quantification.
8. Sample Size for the Training Set:
The document is for a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" in the context of machine learning is not applicable here. Standard immunoassays are developed and validated through laboratory testing and do not typically involve a "training set" in the computational sense. The document does not specify any training set size.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" is not applicable to traditional immunoassays. Therefore, this question cannot be answered from the provided document. Validation of the assay's performance would have been against a recognized reference method (e.g., GC/MS or LC/MS).
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APR 15 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: K991079 Trade Name: AccuSign® BZO Regulatory Class: II Product Code: JXM 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 (QS) 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 Autman
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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(k) Number (if known): <991079
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
……
Immunoassay for the qualitative detection of benzodiazepines 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 drug.
Dean Cooper
Laboratory Devices ivision of Clinical 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:_X Prescription Use:_X r 21 CFR 801.109)
OR
Over The Counter Use: ________
(Optional Format 1-2-96)
i
§ 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).