(95 days)
An in vitro test for the qualitative identification of barbiturates in urine at a cutoff concentration of 200 ng/mL of Secobarbital. Measurements that are obtained by this device are used in the screening for drug abuse.
Immunoassay for the qualitative detection of barbiturates in urine. The QuickScreen™ Test, like many commercially available drug screening test kits, qualitatively measures the presence of barbiturates by visual, color sandwich, one-step immunoassay technology.
Acceptance Criteria and Study for QuickScreen™ Barbiturates Screening Test
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria as achieving "substantial equivalence to the reported performance characteristics of other commercially available tests for the qualitative detection of barbiturates in urine." The specific performance metric provided is agreement with a predicate device.
| Acceptance Criteria | Reported Device Performance (QuickScreen™ Barbiturates Screening Test) |
|---|---|
| Substantial equivalence to predicate devices (qualitative detection of barbiturates in urine) | 97% agreement when compared to the Behring EMIT II |
2. Sample Size and Data Provenance for Test Set:
- Clinical Sample Correlation Study: The exact sample size for this study is not explicitly stated. It refers to "clinical specimens" without specifying the number.
- Data Provenance: Retrospective, as it involved "clinical specimens" and "correlation studies," suggesting analysis of previously collected samples. The country of origin is not specified, but the manufacturer is based in San Diego, California, USA, implying U.S. data.
- Blind-Labeled Spiked Sample Study: The exact sample size for this study is not explicitly stated.
- Data Provenance: Prospective, as it involved "spiked samples," indicating controlled addition of the substance to samples for testing. The country of origin is not specified, but the manufacturer is based in San Diego, California, USA, implying U.S. data.
3. Number and Qualifications of Experts for Ground Truth:
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The adjudication method is not mentioned. The primary comparison is against a "predicate device" (Behring EMIT II) for the clinical samples and through "blind-labeled spiked samples."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focuses on the device's performance against a predicate device and spiked samples, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "clinical sample correlation study and a blind-labeled spiked sample study" evaluate the QuickScreen™ Barbiturates Screening Test's performance independently, comparing its results to a ground truth (either the predicate device's results or the known concentrations in spiked samples).
7. Type of Ground Truth Used:
- Clinical Sample Correlation Study: The ground truth was established by another "commercially available test" – the Behring EMIT II. This is a form of comparative ground truth against an established method.
- Blind-Labeled Spiked Sample Study: The ground truth was based on known concentrations of barbiturates in the "spiked samples." This represents a form of analytical ground truth.
8. Sample Size for the Training Set:
The document does not provide information about a separate training set or its sample size. The studies described appear to be validation or performance evaluation studies, not explicitly detailing a training phase for a learning algorithm.
9. How Ground Truth for Training Set Was Established:
As no training set is explicitly mentioned, the method for establishing its ground truth is not provided. The device described uses "basic immunochemical sandwich assay principle," which is a traditional laboratory method and does not typically involve machine learning requiring a "training set" in the modern sense.
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SEP 2 1 1998
510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)
Identification: QuickScreen™ Barbiturates Screening Test (9020/9021)
Description: Immunoassay for the qualitative detection of barbiturates in urine
Phamatech Name of Manufacturer: 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use; The QuickScreen™ Barbiturates Screening Test is a rapid, qualitative immunoassay for the detection of barbiturates compounds in urine at a cutoff concentration of 200 ng/mL of Secobarbital. This assay is intended for professional use.
This test provides only a preliminary test result. A more specific atternate test method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Barbiturates form a large class of abused pharmaceuticals. These products are anxiolytics, sedatives/hypnotics, anticonvulsants and anesthetic drugs. As CNS depressants, the barbiturates exert effects on excitatory and inhibitory synaptic neurotransmission. The ultra short acting barbiturates used for anesthesia, such as Thiopental, depress excitatory neuronal transmission to a greater extent than the anticonvulsant barbiturates such as Pentobarbital. Barbiturates are rapidly and completely absorbed with nearly 100% bioavailability. Short-acting barbiturates are generally excreted in unne as metabolites, while long-acting barbiturates are orimarily excreted unchanged. Ratios of drugs to metabolites vary, dependent upon duration of action.
Technology: The QuickScreen"" Test, like many commercially available drug screening test kits, qualitatively measures the presence of barbiturates by visual, color sandwich, one-step immunoassay technology. Examples of such predicate devices include the ABMC Rapid Drug Screen (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 / barbiturates / antibody complexes.
Performance: The product performance characteristics of the QuickScreen™ Barbiturates Screening Test were evaluated in a clinical sample correlation study and a blind-labeled spiked sample 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 barbiturates in unne. Correlation studies, using clinical specimens, produced a 97% agreement when compared to the Behring EMIT II (Cupertino, CA 95014).
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ Barbiturates Screening Test is substantially equivalent to a variety of barbiturate detection tests currently in commercial distribution.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 1 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112-113 San Diego, California 92126
Re : K982152 QuickScreen Barbiturates Screening Test Requlatory Class: II Product Code: DIS Dated: August 14, 1998 Received: Auqust 18, 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 The general controls provisions of the Act 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. ਖੇ 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 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 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.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): K982152
Device Name: QuickScreen™ Barbiturates Screening Test
Indications for Use:
An in vitro test for the qualitative identification of barbiturates in urine at a cutoff concentration of 200 ng/mL of Secobarbital. Measurements that are obtained by this device are used in the screening for drug abuse.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
Ci
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number .
Division Sign-Off Division of Clinical Laboratory Devices
510(k) Number:_K9 5 215 2
Prescription Use: / OR Over the Counter: _
Per 21 CFR 801.109
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).