(21 days)
An in vitro diagnostic test for the qualitative identification of benzodiazepines in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.
Immunoassay for the qualitative detection of benzodiazepines in Urine
Here's an analysis of the provided text to extract the requested information, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation | >99% correlation |
| Sensitivity | >99% |
| Specificity | >99% |
| Accuracy | >99% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the numerical sample size for the test set. It refers to a "clinical sample correlation study" and a "blind labeled spiked study," implying real clinical specimens were used.
- Data Provenance: The "clinical sample correlation study" uses "clinical specimens," suggesting prospective or retrospective data from a clinical setting. The specific country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, implying U.S. clinical data. The "blind labeled spiked study" involves artificially prepared samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish the ground truth.
4. Adjudication method for the test set
The document does not describe any specific adjudication method. The ground truth for the clinical correlation study was established by comparison to two predicate devices (ABI SureStep and EMIT II Test).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine and does not involve human readers interpreting images or data where AI assistance would be applicable in the traditional sense. The document states it exhibited "excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users," indicating human operation of the test, but not an MRMC study comparing human interpretation with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is not an algorithm, but a qualitative immunoassay. Its performance is inherent in the test strip's chemical reaction and visual interpretation by "professional users." Therefore, a standalone algorithm performance study is not applicable. The performance described "in the hands of professional users" is essentially the device's standalone performance within its intended use.
7. The type of ground truth used
For the clinical sample correlation study, the ground truth was established by comparing the QuickScreen™ Benzodiazepines Screening Test results to two predicate devices:
- ABI SureStep (San Diego, CA 92121)
- EMIT II Test (San Jose, CA)
For the blind labeled spiked study, the ground truth would be based on the known concentrations of benzodiazepines in the spiked samples.
8. The sample size for the training set
The document does not mention a training set, as immunoassay devices typically do not involve machine learning models that require a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
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JUN 3 1998
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen™ Benzodiazepines Screening Test (9025/9026) ldentification:
Description: Immunoassay for the qualitative detection of benzodiazepines in Urine
Name Of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The QuickScreen™ One Step Benzodiazepines Screening Test is a rapid, qualitative immunoassay for the detection of benzodiazepines compounds in urine. The cut-off concentration for this test is 200 ng/mL. This assay is intended for use in clinical toxicology laboratories, physicians' offices and drug of abuse clinics. Benzodiazepines form one of the largest classes of abused pharmaceuticals. These products are sedative and hypnotics, tranquilizers and anti-anxiety drugs which produce a calming effect, thus they are often prescribed as tranquilizers.
The QuickScreen™ Test, like many commercially available drug Technology: screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC (Ancramdale, NY) and the Applied Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / benzodiazepines / antibody / complexes.
Performance: The product performance characteristics of the QuickScreen™ Benzodiazepines Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen™ Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of benzodiazepines in urine. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the ABI SureStep (San Diego, CA 92121) and the EMIT II Test (San Jose, CA ). A clinical laboratory study was also performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ Benzodiazepines Screening Test is substantially equivalent to a variety of benzodiazepines detection tests currently in commercial distribution.
FDA/CDRH/ODE/DMO
13 May 98 10 42
RECEIVED
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1998 JUN
Carl Mongiovi . Director of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
K981687 Re : QuickScreen™ Benzodiazepines Screening Test (Models 9025, 9026) QuickScreen™ Pro Multi Drug Screening Test (Model 9151) II Regulatory Class: Product Code: JXM May 8, 1998 Dated: Received: May 13, 1998
Dear Mr. Mongiovi:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): k981/687
Device Name: QuickScreen™ Benzodiazepines Screening Test
Indications for Use:
An in vitro diagnostic test for the qualitative identification of benzodiazepines in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number: K 9816 87
Prescription Use: Per 21 CFR 801.109 OR
Over the Counter: ____________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K98/687
§ 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).