(168 days)
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No
The device description and performance studies indicate a standard immunoassay technology with visual interpretation, with no mention of AI or ML.
No
This device is for in vitro diagnostic testing to screen for drug abuse, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "An in vitro diagnostic test for the qualitative identification of methadone in urine."
No
The device description clearly states it is an immunoassay using visual color sandwich one step immunoassay technology, which is a hardware-based test kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro diagnostic test for the qualitative identification of methadone in urine." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body (like urine) to provide information about a person's health.
- Device Description: The description further clarifies it's an "Immunoassay for the qualitative detection of methadone in urine," using "visual color sandwich one step immunoasay technology." Immunoassays are a common type of IVD test.
- Sample Type: The test is performed on urine, which is a biological sample taken from the body.
- Purpose: The purpose is to screen for drug abuse, which is a health-related condition.
All these factors clearly indicate that this device is designed to be used outside of the body to diagnose or provide information about a person's health status, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuickScreen™ 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.
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.
Product codes
DJR
Device Description
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.
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
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.
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.
Clinical specimen testing, using the same set of clinical urine specimens, was also performed at two independent laboratories.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 PhamateR 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% agreement with the Behring EMIT II and GC/MS methodologies.
98% overall agreement in the hands of professional users.
Correctly identified 47 of 49 methadone-positive urine specimens and 60 of 60 methadone-negative urine specimens during clinical specimen testing.
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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§ 862.3620 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).
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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: | Phamatech | |
| 9265 Activity Road #112 | ||
| San 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
Image /page/1/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized depiction of an eagle's head or a similar bird-like figure. The design is rendered in black and appears to be part of a larger circular seal or emblem, as suggested by the curved text visible along the edge. The text reads 'DEPARTMENT OF' and is oriented along the circular border of the emblem.
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: | |
|---|---|
| ----------------- | -- |
| Prescription Use:
| Per 21 CFR 801.109 | OR | Over the Counter: | |
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