(43 days)
ABMC RapidOne BZD test
Not Found
No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an in-vitro diagnostic test used for the detection of benzodiazepines in urine, which helps in the diagnosis and treatment of drug abuse rather than providing direct therapeutic action.
Yes
The text explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of drug abuse." This indicates its role in a diagnostic process.
No
The device description clearly indicates it is an immunoassay test kit that relies on visual color changes, which is a hardware-based diagnostic method, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states "The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen..." and "An invitro diagnostic test for the qualitative detection of... benzodiazepines in urine." It also mentions that measurements are used in the "diagnosis and treatment of drug abuse."
- Device Description: The description details an "Immunoassay for the qualitative detection of Benzodiazepines in urine" and describes the technology as "visual color sandwich one step immunoassay technology," which are characteristics of in vitro diagnostic tests.
- Performance Studies: The document describes performance studies using "clinical sample correlation study" and "clinical specimens," which are typical for evaluating the performance of IVD devices.
The term "in vitro diagnostic" is used multiple times and the description of the device's function and intended use clearly align with the definition of an IVD.
N/A
Intended Use / Indications for 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 is an in-vitro diagnostic screen that provides a rne QuiloRooroon Bonzoulatespines 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.
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.
Product codes
JXM
Device Description
Immunoassay for the qualitative detection of Benzodiazepines in urine
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ABMC RapidOne BZD test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: | Phamatech
10151 Barnes Canyon Road
San 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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Page 2 -
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
3
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
5
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