(168 days)
An in vitro diagnostic test for the qualitative identification of methadone in urine. This test was calibrated against methadone at a cut-off concentration of 300 ng/ml. Measurements obtained by this device are used in screening for drug abuse.
Immunoassay for the qualitative detection of methadone in urine. The QuickScreen™ Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoasay technology.
Here's a breakdown of the acceptance criteria and study details for the QuickScreen™ Methadone Screening Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance used to demonstrate substantial equivalence to predicate devices, particularly the expectation of high agreement with established methods like EMIT II and GC/MS.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement with Methadone-Positive Clinical Specimens | >99% agreement with Behring EMIT II and GC/MS | 49 out of 49 correctly identified (100% agreement) |
| Agreement with Methadone-Negative Clinical Specimens | >99% agreement with Behring EMIT II and GC/MS | 60 out of 60 correctly identified (100% agreement) |
| Overall Agreement (Independent Labs, Professional Users) | High agreement to demonstrate reliability | >98% overall agreement (47/49 positive, 60/60 negative) |
2. Sample Size Used for the Test Set and Data Provenance
- Positive Samples: 49 methadone-positive urine specimens
- Negative Samples: 60 methadone-negative urine specimens
- Data Provenance: The document states "clinical sample kit comparison study, using 49 methadone-positive urine specimens and 60 methadone-negative urine specimens." This indicates the data is from retrospective clinical specimens. There is no specific country of origin mentioned, but the manufacturer is based in San Diego, California, USA, implying the studies were likely conducted within the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using laboratory methods rather than human expert interpretation of the device's results.
- Number of Experts: Not applicable in the traditional sense, as the ground truth was derived from analytical methods.
- Qualifications of Experts: Not specified, but the methods used (Behring EMIT II and GC/MS) are standard laboratory techniques that would be performed by qualified laboratory personnel.
4. Adjudication Method for the Test Set
The ground truth was established by comparison to two established laboratory methods: Behring EMIT II and GC/MS. While not an "adjudication" in the sense of multiple human readers, the use of two independent, highly regarded analytical methods served as the authoritative reference.
- Adjudication Method: Comparison to Behring EMIT II and Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is explicitly stated as "the preferred confirmatory method."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study described is a performance evaluation of a rapid immunoassay device against established laboratory methods. There is no mention of human readers evaluating cases with and without AI assistance (as the device itself is a standalone immunoassay, not an AI assisting human interpretation).
6. Standalone Performance
Yes, a standalone performance study was done. The QuickScreen™ Methadone Screening Test is an "algorithm only" device in the sense that it provides a direct qualitative result (positive/negative) based on a chemical reaction, without human interpretation of complex images or data needing AI assistance. The performance reported directly reflects the device's ability to classify samples on its own.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical laboratory results from established methods. Specifically, Behring EMIT II (an immunoassay) and Gas Chromatography/Mass Spectrometry (GC/MS) (a highly specific and sensitive confirmatory method).
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning. As a rapid immunoassay, the device's "training" refers to its design and calibration, not a machine learning model. The study described is a performance evaluation using clinical samples.
- Sample Size for Training Set: Not applicable or not specified in this type of device evaluation.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set described in the machine learning context, this question is not directly applicable. The device's design and internal calibration would rely on chemical principles and validation against known standards, which is a different process than establishing ground truth for a machine learning training set.
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KG82938
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
| Identification: | QuickScreenTM Methadone Screening Test | |
|---|---|---|
| Description: | Immunoassay for the qualitative detection of methadone in urine | |
| Date Prepared: | 25 January 1999 | |
| Name Of Manufacturer: | Phamatech9265 Activity Road #112San Diego, California 92126, USA | |
| Contact Person(s): | Carl Mongiovi, Director of Operations, and Roland Strickland, Quality Assurance Manager |
Intended Use: The OuickScreen™ Methadone Screening Test is a rapid, qualitative immunoassay used to screen for the detection of methadone in urine at a cutoff concentration of 300 ng/mL. This assay is intended for professional use to assist in preventing drug abuse.
This test provides only a preliminary test result. A more specific alternate test method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result.
Technology: The QuickScreen™ Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoasay 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 assay principle of recognition and formation of specific antibody / target drug complexes.
Performance: The product performance characteristics of the QuickScreen™ Methadone Screening Test were evaluated in a clinical sample kit comparison study, using 49 methadone-positive urine specimens and 60 methadone-negative urine specimens, and in blind-labeled spiked studies. The results of these studies demonstrate the Phamatech OuickScreen™ Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine.
In-house Kit Comparison studies, using clinical specimens, correctly identified 49 of 49 methadone-positive urine specimens and 60 of 60 methadone-negative urine specimens, producing a >99% agreement with the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodologies.
Clinical specimen testing, using the same set of clinical urine specimens, was also performed at two independent laboratories. During clinical specimen testing, the Phamatech QuickScreen™ exhibited excellent overall agreement (>98%) in the hands of professional users by correctly identifying 47 of 49 methadone-positive urine specimens and 60 of 60 methadone-negative urine specimens. Two (2) samples at 324 and 336 ng/mL (8% and 12% above cutoff, respectively) gave negative results with QuickScreen.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech OuickScreen™ Methadone Screening Test is substantially equivalent to a variety of detection tests currently in commercial distribution,
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Public Health Service
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FEB . 5 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carl Mongiovi Director of Operations, and Roland Strickland, Quality Assurance Phamatech 9265 Activity Road #112 San Diego, California 92126
Re: K982938
Trade Name: OuickScreen Methadone Screening Test Regulatory Class: II Product Code: DJR Dated: December 23, 1998 Received: December 29, 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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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): _K
Device Name: QuickScreen™ Methadone Screening Test
Indications for Use:
An in vitro diagnostic test for the qualitative identification of methadone in urine. This test was calibrated against methadone at a cut-off concentration of 300 ng/ml. Measurements obtained by this device are used in screening for drug abuse.
I an Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_98, 2938
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: | |
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| Prescription Use:Per 21 CFR 801.109 | OR | Over the Counter: | |
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§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).