(40 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 any addictive narcotic pain relieving opiate drug, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmaco-logical actions. The opiates include drugs such as morphine, heroin, codeine, nalorphine,meperidine and morphine glucuronide. Measurements that are 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.
The QuickScreenTM One Step Opiates Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (Opiates) test kits, to qualitatively measure the presence of opiates by visual color sandwich one step immunoassay technology.
The provided information describes the Phamatech QuickScreen™ One Step Opiate Screening Test, an immunoassay for the qualitative detection of opiates in urine.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | > 95% | > 95% (specifically 116/116 for clinical samples vs. EMIT II) |
| Specificity | > 99% | > 99% (specifically 35/35 for clinical samples vs. EMIT II) |
| Accuracy | > 97% | > 97% (specifically 151/151 for clinical samples vs. EMIT II) |
Note: The acceptance criteria are implied from the "Performance" section which states the device "produced a sensitivity of >95%, specificity of >99% and accuracy >97%". This suggests these values were the targets for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical specimens" producing 116/116 sensitive results, 35/35 specific results, and 151/151 accurate results. This suggests a total of 151 clinical samples were used in the correlation study against the predicate device.
- Data Provenance:
- Country of Origin: USA (Phamatech is located in San Diego, California, and clinical testing sites are in San Diego, CA).
- Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. However, it refers to "clinical sample correlation study," which often implies analysis of existing samples, but without further detail, it's not definitively one or the other.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, it states that the performance was evaluated against a predicate device, the Syva EMIT II immunoassay, and tests were conducted "in the hands of professional laboratory technicians."
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison was directly against the Syva EMIT II immunoassay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This device is an in-vitro diagnostic test, and the performance evaluation focuses on direct comparison to a predicate assay, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, standalone performance was done. The entire performance section describes the algorithm's (the immunoassay's) performance characteristics (sensitivity, specificity, accuracy) when compared to a predicate device. This is a standalone evaluation demonstrating the device's ability to detect opiates in urine without human interpretation beyond reading the visual color change.
7. Type of Ground Truth Used
The ground truth used was the results from a predicate device, the Syva EMIT II immunoassay. This is a common method for establishing substantial equivalence for new IVD devices, comparing their performance to an established, legally marketed device.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. Immunoassays are typically developed and validated using a different paradigm than AI/machine learning models which require distinct training and testing sets. The performance study refers to clinical validation rather than machine learning training.
9. How the Ground Truth for the Training Set was Established
As no separate training set is mentioned in the context of machine learning, this question is not applicable in the way it would be for an AI device. The development and optimization of the immunoassay itself would have involved internal validation and calibration using known positive and negative samples, but these are not described as a "training set" in the context of the 510(k) summary. The "ground truth" for the clinical performance evaluation (test set) was the predicate device's results.
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AUG 20 ..
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen TM One Step Opiate Screening Test (9080) ldentification:
Immunoassay for the Qualitative Detection of Opiates in Urine Description:
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 any addictive narcotic pain relieving opiate drugs, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmacological actions. Measurements that are obtained by this device are used in the diagnosis and treatment of Opiates use or overdose
The QuickScreenTM One Step Opiates Test utilizes colloidal gold as the Technology: label like other commercially available immunoassays for drug of abuse (Opiates) test kits, to qualitatively measure the presence of opiates 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 Opiates Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Opiates / antibody / complexes.
Performance: The product performance characteristics of the QuickScreenTM One Step Opiates Test was evaluated in a clinical sample correlation study and a blind labeled Opiates study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Opiates Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Opiates in urine. Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97% when compared to the Syva EMIT II (San Jose, CA 95161) . Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (116/116), specificity (35/35), and accuracy (151/151) versus the EMIT II immunoassay in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step Opiates ScreeningTest is substantially equivalent to a variety of qualitative Opiates tests currently in commercial distribution.
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510(k) SUMMARY As Required By Section 807.92(c)
QuickScreen™ Opiate Screening Test
Immunoassay for the Qualitative Detection of Opiate and its metabolites in Urine
| Name of Product: | QuickScreen™ One Step Opiate Screening Test |
|---|---|
| Name Of Packager: | Phamatech9265 Activity Road #112San Diego, California 92126USA |
| Name Of Manufacturer: | Phamatech9265 Activity Road #108San Diego, California 92126USA |
| Site of Control Testing: | Phamatech9265 Activity Road #112San Diego, California 92126USA |
| Sites of Clinical Testing: | Poison Laboratories7272 Clairemont Mesa Blvd.San Diego, CA 92111Quest Diagnostics Incorporated7470 Mission Valley RoadSan Diego, CA 92108 |
Regulatory Control Number: 012
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carl A. Mongiovi Director of Operations Phamatech 9265 Activity Roads Suite 112-113
AUG 20 1997
San Diego, California 92126 ·
Re: K972619 QuickScreen™ One Step Opiate Screening Test Trade Name: Product Code: DJG Requlatory Class: II DJJ II Dated: July 8, 1997 Received: July 11, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (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 requlatory 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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): K972619
Device Name: QuickScreen TM One Step Opiate 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 in-vitro diagnostic test for the qualitative identification of any addictive narcotic pain relieving opiate drug, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmaco-logical actions. The opiates include drugs such as morphine, heroin, codeine, nalorphine,meperidine and morphine glucuronide. Measurements that are 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.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
hronica J. Calvin for 4. Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972619
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
Prescription Use:
OR Over the Counter
§ 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).