(174 days)
No
The description details a standard enzyme immunoassay for detecting benzodiazepines in urine. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are standard analytical comparisons, not AI/ML model validation.
No.
This device is an in vitro diagnostic assay used for qualitative analysis of benzodiazepines in human urine, which helps in diagnosing benzodiazepine use or overdose, rather than treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of benzodiazepines use or overdose." This clearly indicates its diagnostic purpose.
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a "homogeneous enzyme immunoassay" based on chemical reactions and spectrophotometric measurement, indicating it is a physical kit or reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the qualitative analysis of benzodiazepines in human urine and that the measurements are used in the diagnosis of benzodiazepines use or overdose. This clearly indicates a diagnostic purpose.
- Device Description: The "Device Description" section describes the assay as an "in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine." This directly labels the device as an IVD.
- Sample Type: The device analyzes human urine, which is a biological specimen. IVDs are designed to test biological specimens.
- Care Setting: The intended user is "clinical laboratories," which is a typical setting for the use of IVD devices.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Benzodiazepines assay is used for the qualitative analysis of benzodiazepines in human urine with a cutoff of 200 ng/mL. For use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepines use or overdose. The Benzodiazepines assay is calibrated with lormetazepam and will detect a variety of benzodiazepines and their metabolites. The Benzodiazepines assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
JXM
Device Description
The Benzodiazepines assay is an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine. The assay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff. The assay is based on competition between a drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET® System. The Benzodiazepines assay method comparison yielded acceptable correlation with the Emit II Benzodiazepine assay on the SYVA-30R Analyzer. The concordance table shows: 99% agreement. The Benzodiazepines assay method comparison yielded acceptable correlation with GC/MS. The concordance table shows 87% agreement with GCMS. The clinical specimens tested ranged from 57.5 to 13,174.0 ng/mL. Precision studies were conducted using the Benzodiazepines assay. A within-run and total precision study was performed using five levels of material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The total %CV for Verifier I is 1.36%. The total %CV for the Cutoff Calibrator is 1.48%. The total %CV for Verifier II is 1.10%. The total %CV for the -25% Control of Cutoff Calibrator and the +25% Control of Cutoff Calibrator samples are 1.92% and 1.60% respectively. The Benzodiazepines cutoff is 200 ng/mL. The limit of detection (sensitivity) of the Benzodiazepines assay is 15 ng/mL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAR 1 3 2002
Trade/Device Name: Benzodiazephines Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiaphines test system Regulatory Class: Class II Product Code: JXM Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Morris:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I nits lotter will and the program al equivalence of your device to a legally marketed prealicate 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 1 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, (1) see contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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
5
510(k) Number (if known): K013143
Benzodiazepine Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
gualitative analysis of benzodiazepines in human The Benzodiazepines assay is t in clinical laboratories. Measurements obtained by this urine with a cutoff of 200 ng/m1 for use ent of benzodiazepines use or overdose. device are used in the diagnosis at
with lormetazepam and will detect a variety of The Benzodiazepines assay is calibrated benzodiazepines and their metabolites
The Benzodiazepines assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive s are used.
a) Laboratory Devices
ONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW TI
Prescription Use (Per 21 CFR 801.109)
of Device Evaluation (ODE) Concurrence of C
Over-The-Counter Use_
(Optional Format 1-2-96)