(95 days)
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.
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.
The provided text describes the 510(k) summary for the QuickScreen™ Oxycodone Test. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format (e.g., Sensitivity > X%, Specificity > Y%). However, it makes a general claim of substantial equivalence.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices | >99% correlation when compared to predicate devices in laboratory studies using clinical specimens. |
| Qualitative immunoassay for detection of oxycodone in urine at a cutoff concentration of 100 ng/ml. |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: Not explicitly stated as a number of samples. It mentions "clinical sample correlation study" and "laboratory studies, using clinical specimens."
- Data Provenance: "clinical sample correlation study" and "laboratory studies, using clinical specimens." No specific country of origin is mentioned, but the manufacturer is based in San Diego, California, USA, suggesting a US context. The study is retrospective given "clinical specimens" would imply pre-existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The study compares the QuickScreen™ Oxycodone Test to "predicate devices," implying the predicate device's results were used as a reference, but no information on how the predicate device's results themselves were adjudicated is given.
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
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for drug detection, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a rapid, qualitative immunoassay designed for "professional use," which implies a human in the loop for interpretation of the visual color change. However, the performance reported (" >99% correlation") likely refers to the intrinsic performance of the test strip itself against a reference method or predicate, acting as a standalone evaluation of the device's accuracy in detecting the analyte. It's an "algorithm only" in the sense that the test strip is a chemical algorithm.
7. The Type of Ground Truth Used
The ground truth for the "clinical sample correlation study" and "laboratory studies, using clinical specimens" appears to be the results obtained from predicate devices (e.g., ABMC RapidOne Oxycodone test) and likely a confirmatory analytical method mentioned later as the "preferred confirmatory method" once a preliminary positive result is obtained (Gas chromatography/mass spectrometry (GC/MS)). The statement "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" suggests that these methods serve as the ultimate ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires separate training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is not applicable and hence, not provided.
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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)
41
(Division Sign-Off)
pating
Division of Clinical Laboratory Deviees
510(k) Number K043051
§ 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).