(36 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of tetrahydrocannabinoid, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use or overdose.
The QuickScreenTM One Step THC Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of THC by visual color sandwich one step immunoassay technology.
Here's an analysis of the provided text regarding the QuickScreen™ One Step THC Screening Test, structured according to your requested points:
Acceptance Criteria and Device Performance Study
The information provided describes a qualitative immunoassay for the detection of Tetrahydrocannabinoid (THC) in urine. The primary study presented is a clinical sample correlation study used to demonstrate substantial equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state pre-defined "acceptance criteria" in numerical terms (e.g., "Sensitivity must be >95%"). Instead, it reports the performance values achieved and concludes that these demonstrate "substantial equivalence" to other commercially available tests. The acceptance is implied by meeting or exceeding the performance characteristics of predicate devices.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | >98% (compared to Syva EMIT II) | >98% |
| Specificity | >98% (compared to Syva EMIT II) | >98% |
| Accuracy | >99% (compared to Syva EMIT II) | >99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. It mentions "clinical sample correlation study" and "two independent clinical laboratories," but the number of samples or cases used in these studies is not provided.
- Data Provenance: The data is from "clinical specimens." The country of origin is not explicitly stated, but the manufacturer (Phamatech) is in San Diego, California, USA, and the predicate device (Syva EMIT II) is from San Jose, CA. It is highly probable the data is from the USA. The study appears to be retrospective, using existing clinical specimens, although this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the traditional sense of human readers interpreting images. The ground truth was established by comparison to a predicate device, the Syva EMIT II.
- Qualifications of Experts: The "experts" are the Syva EMIT II device itself, which is a "commercially available immunoassay." The document states that "Two independent clinical laboratories conducted studies which demonstrated the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians," implying general laboratory expertise, but not specific individual experts for ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a comparison of a new device's output against a reference device's output, not a human consensus or adjudication of interpretations. The "correlation studies" are a direct comparison of results between the QuickScreen™ test and the Syva EMIT II.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a standalone in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, a standalone performance study was done. The QuickScreen™ One Step THC Screening Test is an "in-vitro diagnostic test for the qualitative identification of Tetrahydrocannabinoid... in urine." Its performance characteristics (sensitivity, specificity, accuracy) were evaluated by comparing its results directly against those of the Syva EMIT II. The "studies which demonstrated the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians" refers to the operational use of the device itself, not human-in-the-loop interpretation improvement.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by a predicate device/reference method, specifically the Syva EMIT II. The EMIT II is an established immunoassay for THC detection.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This document describes the performance evaluation of a device, not the development or training of an algorithm that would require a separate training set. Immunoassays are generally developed through biochemical and analytical optimization, not statistical training on labeled datasets in the same way machine learning models are.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no mention of a "training set" in the context of this device's development as described. The device operates on established immunochemical principles.
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SEP 2 5 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: OuickScreen TM One Step THC Screening Test (9075)
Immunoassay for the Qualitative Detection of Tetrahydrocannabinoid in Description: Urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA
Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of tetrahydrocannabinoid, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use or overdose
Technology: The QuickScreenTM One Step THC Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of THC by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego, CA 92121)and the Syntron Bioresearch THC Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / THC / antibody / complexes.
Performance: The product performance characteristics of the QuickScreen™ One Step THC Screening Test was evaluated in a clinical sample correlation study and a blind labeled THC study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step THC Screening Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine.
Correlation studies, using clinical specimens, produced a sensitivity of greater than 98%, a specificity of greater than 98% and accuracy greater than 99% when compared to the Syva EMIT II (San Jose, CA 95161).
Two independent clinical laboratories conducted studies which demonstrated the Phamatech OuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians.
For the reasons mentioned above, it may be concluded that the Phamatech Conclusion: QuickScreenTM One Step THC ScreeningTest is substantially equivalent to a variety of qualitative THC screening tests currently in commercial distribution.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three wavy lines representing its wings or body.
SEP 2 5 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tuan H. Pham . President Phamatech, Inc. 9265 Activity Road, Suite 112-113 San Diego, California 92126
Re : K973122 QuickScreen™ One Step THC Test Requlatory Class: II Product Code: LDJ August 20, 1997 Dated: Received: Auqust 20, 1997
Dear Tuan H. Pham:
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, Druq, 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. ਸੀ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 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.qov/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): __
Device Name: QuickScreen TM One Step THC Screening Test
Indications for Use:
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an invitro diagnostic test for the qualitative identification of Tetrahydrocannabinoid (THC), a hallucinogenic compound and principle active component in marijuana, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. R973/22
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
Prescription Use:
Per 21 CFR 801.109
OR Over the Counter _____________________________________________________________________________________________________________________________________________________________
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).