(58 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 phencyclidine (PCP), a hallucinogenic compound in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of phencyclidine (PCP) use.
The QuickScreen TM One Step PCP 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 PCP by visual color sandwich one step immunoassay technology.
Please find the detailed analysis of the acceptance criteria and the study proving the device's performance below, based on the provided text.
Acceptance Criteria and Device Performance Study for QuickScreen™ One Step PCP Screening Test
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | > 99% | > 99% |
| Specificity | > 99% | > 99% |
| Accuracy | > 99% | > 99% |
Note: The document states the device exhibited "excellent performance" and "substantially equivalent" to predicate devices. The specific acceptance criteria are inferred from the reported performance results, as they met or exceeded "greater than 99%" across all three metrics. This high threshold is common for qualitative diagnostic tests for drugs of abuse to ensure reliable detection.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The performance was evaluated using "clinical sample correlation study" and a "blind labeled PCP study." correlation studies, using "clinical specimens."
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical specimens" and "blind labeled PCP study" but does not quantify the number of samples used in these studies.
- Data Provenance: The studies were conducted by "Two independent clinical laboratories." The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA, and the FDA submission is to the US FDA, suggesting the studies were likely conducted within the USA. The studies were prospective as they involved testing the device on clinical samples and a blind labeled study, rather than re-analyzing existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth was established by comparison with a predicate device, the "Syva EMIT II," which is a laboratory-based immunoassay. Therefore, the "experts" in this context would likely be the qualified laboratory personnel operating and interpreting the results of the predicate device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. However, since the device's performance was compared to the "Syva EMIT II," a well-established immunoassay, the Syva EMIT II's results likely served as the reference standard without a separate adjudication process involving multiple human readers for conflict resolution on the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on the standalone performance of the QuickScreen™ device compared to a predicate immunoassay. The document does not mention human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, a standalone performance study was conducted. The QuickScreen™ One Step PCP Screening Test is an in-vitro diagnostic test that provides a visual color change for qualitative detection. Its performance metrics (sensitivity, specificity, accuracy) were directly compared to a predicate device (Syva EMIT II), representing its standalone capability without human interpretation being the primary variable. The phrasing "excellent performance in the hands of professional laboratory technicians" refers to the operation of the device rather than human-in-the-loop clinical decision-making.
7. Type of Ground Truth Used
- Ground Truth Type: The ground truth was established by comparison to a predicate device's results. Specifically, the "Syva EMIT II" (San Jose, CA 95161), another commercially available immunoassay for PCP, served as the reference standard for determining true positives, true negatives, false positives, and false negatives.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The QuickScreen™ One Step PCP Screening Test is a qualitative immunoassay kit, not an AI/ML algorithm. Therefore, it does not have a "training set" in the context of machine learning. Its "training" is inherent in its chemical and biological design established during its development.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable, as this device does not use a training set in the machine learning sense. The device's design and manufacturing are based on established immunochemical principles for drug-of-abuse testing, rather than being "trained" on a dataset.
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974582
1 1998 FEB
SUMMARY
OuickScreenTM One Step PCP Screening Test (9130) Identification:
Immunoassay for the Qualitative Detection of Phencyclidine in Urine Description:
US FDA 510(k) Number:
Establishment Registration Number: 2030941
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 phencyclidine in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of PCP use or overdose
The QuickScreen TM One Step PCP Screening Test utilizes colloidal gold as Technology: the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of PCP 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 PCP Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / PCP / antibody / complexes.
The product performance characteristics of the QuickScreenTM One Step Performance: PCP Screening Test was evaluated in a clinical sample correlation study and a blind labeled PCP study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step PCP 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 99%, a specificity of greater than 99% 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.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreenTM One Step PCP ScreeningTest is substantially equivalent to a variety of qualitative PCP screening tests currently in commercial distribution.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 4 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
Re : K974582 QuickScreen™ One Step PCP Screening Test Requlatory Class: Unclassified Product Code: LCM December 5, 1997 Dated: Received: December 8, 1997
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. ਸ 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 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 Litman
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 PCP 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 phencyclidine (PCP), a hallucinogenic compound in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of phencyclidine (PCP) use.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
y
Division Sign-Off) Division of Clinical Laborato 510(k) Number
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
Prescription Use: Per 21 CFR 801.109
OR Over the Counter
N/A