(95 days)
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No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML.
No.
The device is a rapid, qualitative immunoassay for the detection of Oxycodone in urine, providing only a preliminary test result for drug screening, not a therapeutic intervention.
Yes
This device is a rapid, qualitative immunoassay intended for the detection of Oxycodone in urine, providing a preliminary test result for diagnostic purposes.
No
The device description clearly indicates it is an immunoassay test kit that relies on visual color changes and immunochemical principles, which are hardware-based components and processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of Oxycodone in urine." Urine is a biological specimen taken from the body.
- Device Description: It describes an "Immunoassay for the qualitative detection of Oxycodone in urine." Immunoassays are a common type of in vitro diagnostic test.
- Mechanism: It relies on "immunochemical sandwich assay principle," which is a method used to detect substances in biological samples outside of the body.
- Sample Type: The test is performed on "urine," which is an in vitro sample.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help detect, diagnose, or monitor diseases or conditions. This device fits that description perfectly as it analyzes a urine sample to detect the presence of oxycodone.
N/A
Intended Use / Indications for Use
The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of the oxycodone in urine. The cutoff concentration for this test is 100 ng/ml. This assay is intended for professional use.
The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use.
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
Immunoassay for the qualitative detection of Oxycodone in urine
The QuickScreen™ Oxycodone Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.
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
professional use
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)
The product performance characteristics of the QuickScreen™ Oxycodone Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen™ Oxycodone Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the oxycodone in urine. Laboratory studies, using clinical specimens, produced a >99% correlation when compared to the predicate devices.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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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K 043051
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen™ Oxycodone Test (Models 9120, 9120T, 9120X and 9121) Identification:
Description: Immunoassay for the qualitative detection of Oxycodone in urine
Name Of Manufacturer:
Phamatech 10151 Barnes Canyon Road San Diego, California 92121, USA
Intended Use: The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of the oxycodone in urine. The cutoff concentration for this test is 100 ng/ml. This assay is intended for professional use.
The QuickScreen™ Oxycodone Test, like many commercially available Technology: oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC RapidOne Oxycodone test (Kinderhook, NY). These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.
The product performance characteristics of the QuickScreen™ Oxycodone Performance: Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen™ Oxycodone Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the oxycodone in urine. Laboratory studies, using clinical specimens, produced a >99% correlation when compared to the predicate devices.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen™ Oxycodone Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the professional user.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected by flowing lines, representing health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 7 2005
Mr. Carl Mongiovi Vice President Phamatech Inc. 10151 Barnes Canyon Road San Diego, CA 92121
Re: K043051
Trade/Device Name: QuickScreen Oxycodone Test Model 9120, 9120T, 9120X, and 9121 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: January 5. 2005 Received: January 19, 2005
Dear Mr. Mongiovi:
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,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. 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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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number K043051:
Device Name: QuickScreen Oxycodone Test Model 9120, 9120T, 9120X and 9121 Indications for Use:
The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use.
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Prescription Use: Over the Counter: AND/OR 21 CFR 807 Subpart C Part 21 CFR 801 Subpart D
Concurrence of CDRH Office of In Vitro Diagnostic Devices (OIVD)
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(Division Sign-Off)
pating
Division of Clinical Laboratory Deviees
510(k) Number K043051