(80 days)
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: amphetamine, cocaine, methamphetamine, opiates, PCP and THC
Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine.
The Phamatech QuickScreen™ At Home Drug Test (Models 9149 and 9150) is an immunoassay device intended for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, and THC in urine, for use in the home.
Here's an analysis of its acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the claim is demonstrating substantial equivalence to existing devices. The reported device performance is measured against predicate devices and analytical methods.
| Drug Detected | Cut-off Concentration (ng/ml) | Reported Device Performance | Reference Standard |
|---|---|---|---|
| Amphetamine | 1000 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
| Cocaine | 300 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
| Methamphetamine | 500 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
| Opiates | 300 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
| PCP | 25 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
| THC | 50 | >99% correlation; >98% overall accuracy (professional users); >96% overall accuracy (lay users) | Behring EMIT II, GC/MS methodology, predicate commercial tests |
Note: The performance values for each drug are not individually broken out but are reported as general figures across all target drugs.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "clinical sample correlation study" and "clinical studies" but does not provide the number of specimens used.
- Data Provenance:
- Clinical Sample Correlation Study: Used "clinical specimens," suggesting real-world samples. The country of origin is not specified but given the manufacturer's location (San Diego, California, USA) and the context of FDA submission, it's highly likely to be U.S. data.
- Blind Labeled Spiked Study: This study likely used controlled, prepared samples with known drug concentrations (spiked samples).
- Retrospective/Prospective: Not specified, but "clinical sample correlation study" could imply retrospective analysis of collected samples or prospective collection. The spiked study would be prospective by nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The ground truth in the "clinical sample correlation study" was established by comparison to the Behring EMIT II and GC/MS methodology. These are established laboratory methods.
- The "clinical studies" were "performed at two independent laboratories," implying professional users or laboratory personnel.
- The "consumer study" involved "lay users."
- Number of Experts/Qualifications: Not explicitly stated in terms of individual expert numbers or their exact qualifications (e.g., "radiologist with 10 years experience"). However, the use of GC/MS (Gas Chromatography-Mass Spectrometry) implies highly trained analytical chemists or laboratory professionals. Behring EMIT II is also a professional laboratory assay.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described. Since the ground truth was established by comparison to laboratory methods (Behring EMIT II and GC/MS), this implies a direct comparison rather than an expert consensus adjudication process in the typical sense. For the lay user study, the "accuracy" was likely measured against these same laboratory-confirmed results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with and without AI assistance.
- However, the study implicitly compares the device's performance when used by "professional users" vs. "lay users," demonstrating its performance in different user groups. It also compares the device's standalone performance to established laboratory methods and other commercial tests.
6. Standalone Performance (Algorithm Only)
- Yes, a standalone performance study was done. The "clinical sample correlation study" and "blind labeled spiked study" evaluated the QuickScreen™ Test's inherent ability to detect target drugs. The comparison to Behring EMIT II and GC/MS represents the device's performance in isolation from human interpretation variation (though human action is still involved in performing the test).
- The "clinical studies... in the hands of professional users" and "consumer study... in the hands of lay users" evaluate the device's performance with human interaction, but the core measurement is still the device's accuracy.
7. Type of Ground Truth Used
The ground truth used was based on:
- Laboratory Reference Methods: Behring EMIT II (a predicate immunoassay) and GC/MS (Gas Chromatography-Mass Spectrometry), which is considered a gold standard for drug confirmation in many contexts due to its specificity and sensitivity.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This is common for predicate-based 510(k) submissions for in-vitro diagnostic devices, especially those using established immunoassay technologies. The device's performance is typically evaluated on a test set, and its design would be based on general knowledge of immunoassay development rather than a specific "training set" in the machine learning sense.
9. How Ground Truth for the Training Set Was Established
As no separate training set is mentioned or implied, the question of how its ground truth was established is not applicable in the context of this summary. The device's design and analytical performance rely on the established principles of sandwich immunoassay technology and comparison to recognized predicate devices and laboratory methods.
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OCT 1 6 1998
610 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen™ At Home Drug Test (Model 9149 and 9150) ldentification:
Description: Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine.
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The QuickScreen™ At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: amphetamine; 1000 ng/ml, cocaine; 300 ng/ml, methamphetamine; 500 ng/ml, opiates; 300 ng/ml, PCP; 25 ng/ml and THC; 50 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory.
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 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 / target drug / antibody / complexes.
The product performance characteristics of the QuickScreen™ At Home Performance; Drug 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 the stated target drugs in urine. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies, performed at two independent laboratories, were also performed. In them the Phamatech QuickScreen™ exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed., in it the QuickScreen™ At Home Drug Test exhibited excellent overall accuracy (>96%) in the hands of lay users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen™ At Home Drug Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 16 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112/113 San Diego, California 92126
K982621 Re : QuickScreen™ At Home Drug Test Requlatory Class: II Product Code: MVO Dated: July 24, 1998 Received: July 28, 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 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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
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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 requlation (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 Gutman
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): _ K982621
Device Name: QuickScreen™ At Home Drug Test
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: amphetamine, cocaine, methamphetamine, opiates, PCP and THC
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
emonts
Division Sign-Off)
vision of Clinical Laboratory Devices
0(k) Number. K982621
Division Sign-off
Division of Clinical Laboratory Devices
510 (k) Number
| Prescription Use: | |
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| Per 21 CFR 801.109 |
OR
| Over the Counter: | ✓ |
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N/A