(28 days)
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine and PCP OR Methamphetamine in urine. The QuickScreen Pro Multi Drug Drug Screening Test, like many commercially available drug screening test kits, qualitatively measures of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical "acceptance criteria" are not explicitly stated in a formalized table within the document, the performance metrics achieved by the device serve as the de-facto acceptance benchmarks for substantial equivalence. The document primarily focuses on correlation and overall accuracy.
| Performance Metric | Reported Device Performance | Acceptance Criteria (Implied) |
|---|---|---|
| Correlation to Behring EMIT II and GC/MS | >98% correlation | Likely >95% (based on "substantially equivalent") |
| Overall Accuracy (professional users) | >97% overall accuracy | Likely >95% (based on "excellent overall accuracy") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical sample correlation study" and "blind labeled spiked study" but does not provide the number of samples used in these studies.
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated, though a "clinical sample correlation study" usually implies prospective collection of clinical samples. "Blind labeled spiked study" would involve prospectively prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The study involved "professional users" in clinical settings, but their specific qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The study evaluated the device's performance against reference methods and in the hands of professional users, but not in a head-to-head comparison with human readers, or how it improves human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the studies described (correlation with GC/MS and EMIT II, and overall accuracy) appear to demonstrate the standalone performance of the device. The device itself is a qualitative immunoassay, and its performance is assessed directly.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Reference Laboratory Methods: The primary ground truth for the correlation study was established using the Behring EMIT II (an established immunoassay) and GC/MS (Gas Chromatography/Mass Spectrometry) methodology. GC/MS is considered a gold standard for drug detection and quantification in forensic and clinical toxicology.
- Clinical Specimen Results: For the "overall accuracy" study, the ground truth would have been derived from the reference methods applied to the clinical specimens.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an immunoassay (a biochemical test), not a machine learning algorithm that requires a "training set" in the conventional sense. Its performance is inherent to its biochemical design.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as it's not a machine learning algorithm requiring a training set. The device's design and manufacturing processes would be based on established immunological principles and verified through analytical validation.
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OCT 20 1999
510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)
QuickScreen Pro Multi Drug Screening Test (Model 9177 and 9178) ldentification:
Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine and PCP OR Methamphetamine in urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: QuickScreen Pro Multi Drug Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: methamphetamine; 500 ng/ml, amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml and opiates; 2000 ng/ml. This assay is-intended to assist in the prevention of drug abuse
The QuickScreen Pro Multi Drug Drug Screening Test, like many commercially Technology: available drug screening test kits, qualitatively measures of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home DrugTest and the Phamatech QuickScreen Pro Multi Drug ScreeningTest. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug-/-antibodv / complexes.
The product performance characteristics of the QuickScreen Pro Multi Drug Performance: Drug Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen Pro Multi Drug Screening 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. Correlation studies, using clinical specimens, produced a >98% 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 (>97%) in the hands of professional users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen Pro Multi Drug Drug Screening 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 20 1999
Mr. Carl A. Mongiovi Vice President of Operations PhamaTech 9265 Activity Road Suite #112 San Diego, California 92126
Re: K993165
Trade Name: QuickScreen Pro Multi Drug Screening Test Regulatory Class: II Product Code: DJG, DKZ, LAF, DIO, LCL, LDJ Dated: September 20, 1999 Received: September 22, 1999
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 (OS) 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 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): _K 993/4) S
Device Name: QuickScreen Pro Multi Drug Screening Test (Model 9177 & 9178)
Indications for Use:
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.
Lam Corpin
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993165
PI.F.ASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Division Sign-off
Division of Clinical Laboratory Devices
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| Pcr 21 CFR 801.109 |
§ 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).