(43 days)
The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use.
The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a qualitative detection of benzodiazepines in urine. It is intended for professional use only.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone 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 of Benzodiazepines in urine
The QuickScreen™ Benzodiazepines Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition of specific antibody / target analyte / antibody / complexes.
The Phamatech QuickScreen™ Benzodiazepines Test (Models 9025, 9026, 9027T, 9153 and 9195X) is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine, with a cutoff concentration of 200 ng/ml. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to commercially available tests for qualitative detection of benzodiazepines in urine. | 97.9% correlation when compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical sample correlation study" and "blind labeled spiked study" but does not provide the exact number of samples used in either study.
- Data Provenance: The document states "Laboratory studies, using clinical specimens," which implies the data is from prospective clinical samples. The country of origin is not specified but given the manufacturer (Phamatech, San Diego, California, USA) and the FDA filing, it's highly likely to be from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The study compared the device's performance against "predicate devices," suggesting the predicate device's results were used as the reference or "ground truth," rather than expert adjudication of the samples themselves.
4. Adjudication Method for the Test Set
- None explicitly described in terms of expert adjudication. The study design indicates a comparison to "predicate devices," implying the results generated by these established devices served as the reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a qualitative immunoassay for drug detection, where the reading is typically a direct visual interpretation (e.g., presence or absence of a line) and not subject to the same kind of reader variability or interpretation as imaging studies.
- Therefore, the effect size of how much human readers improve with AI vs without AI assistance is not applicable to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance reported is inherently standalone. The QuickScreen™ Benzodiazepines Test is a single-step immunoassay that provides a visual qualitative result. The reported 97.9% correlation is the performance of the device itself (algorithm/assay only) when compared to predicate devices. There is no "human-in-the-loop" aspect to its core diagnostic function; the human merely reads the visual output.
7. The Type of Ground Truth Used
- The ground truth used was the results from predicate devices. The study achieved a "97.9% correlation when compared to the predicate devices." This implies that the performance of existing, legally marketed benzodiazepine screening tests was used as the reference standard against which the QuickScreen™ Benzodiazepines Test was evaluated.
8. The Sample Size for the Training Set
- This information is not provided in the document. As an immunoassay, the device itself doesn't typically undergo "training" in the sense of machine learning algorithms. Its design and manufacturing are established, and then its performance is validated.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" with established ground truth. Its performance characteristics are inherent to its chemical and biological design.
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DEC 2 9 2004
K043/67
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen™ Benzodiazepines Test (Models 9025, 9026, 9027T, 9153 and ldentification: 9195X)
Description: Immunoassay for the qualitative detection of Benzodiazepines in urine
| Name Of Manufacturer: | Phamatech10151 Barnes Canyon RoadSan Diego, California 92121, USA |
|---|---|
| ----------------------- | --------------------------------------------------------------------------- |
Intended Use: The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use.
The QuickScreen™ Benzodiazepines Test, like many commercially available Technology: oxycodone screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC RapidOne BZD test (Kinderhook, NY). These devices rely on the basic immunochemical sandwich assay principle of recognition of specific antibody / target analyte / antibody / complexes.
The product performance characteristics of the QuickScreen™ Performance: Benzodiazepines Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen™ Benzodiazepines Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of benzodiazepines in urine. Laboratory studies, using clinical specimens, produced a 97.9% correlation when compared to the predicate devices.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen™ Beenzodiazepines Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the professional user.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 2004
Mr. Carl A. Mongiovi Vice President Phamatech, Inc. 10151 Barnes Canyon Road San Diego, CA 92121
Re: K043167
Trade/Device Name: Phamatech QuickScreen™ Benzodiazepines Test Models 9025, 9026 and 9027T Phamatech QuickScreen™ Pro Multi Drug Screening Test Models 9153T Phamatech QuickScreen™ Pro Drug Cup Model 9195X
Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: December 21, 2004 Received: December 22, 2004
Dear Mr. Mongiovi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours
Corneria B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): __________________________________________________________________
Device Name: Phamatech QuickScreen™ Benzodiazepines Test Models 9026 and 9027T
Indications for Use:
The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a rne QuiloRooroon Bonzoulatespines of benzodiazepines in urine. It is intended for professional use only.
____ AND/OR Prescription Use: ____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D
510/K
Over the Counter Use: (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of the CDRH Office off In Vitro Diagnostic Devices (OIVD)
Acting
Division/Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
Page 1 of 1
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): Kou 3167-
Device Name: Phamatech QuickScreen™ Pro Multi Drug Screening Test Model 9153T
Indications for Use:
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone 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.
AND/OR X Prescription Use: (Part 21 CFR 801 Subpart D
Over the Counter Use: (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of the CDRH Office of In Vitro Diagnostic Devices (OIVD)
Division/Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K043167
Page 1 of 1
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _K 043 (67- -
Device Name: Phamatech QuickScreen™ Pro Drug Cup Model 9195X
Indications for Use:
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, An Inntro ultagines, PCP, benzodiazepines, barbiturates, methadone 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.
X___________________________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use: (Part 21 CFR 801 Subpart D
Over the Counter Use: (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of the CDRH Office of In Vitro Diagnostic Devices (OIVD)
Division/Sign-6 Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043167
Page 1 of 1
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).