(450 days)
Not Found
No
The device description explicitly states it uses "visual color sandwich one step immunoassay technology" and there are no mentions of AI, ML, or image processing. The performance studies describe traditional laboratory methods and statistical analysis, not AI/ML model training or evaluation.
No.
The device is an in-vitro diagnostic test used to detect drugs/metabolites in urine, and measurements obtained are used in the diagnosis and treatment of drug abuse, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "The QuickScreen Drug Screening Test System is for in-vitro diagnostic use" and "Measurements obtained by this device are used in the diagnosis and treatment of drug abuse."
No
The device description explicitly states it uses "visual color sandwich one step immunoassay technology," which is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated in Intended Use: The Intended Use section clearly states: "The QuickScreen Drug Screening Test System is for in-vitro diagnostic use" and "The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test".
- Purpose of Measurement: The Intended Use also states that the measurements obtained are "used in the diagnosis and treatment of drug abuse." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease or other conditions.
- Device Description: The description of the device as a "qualitative immunoassay" for detecting substances in urine further supports its classification as an IVD, as it's performing a test on a biological sample.
N/A
Intended Use / Indications for Use
The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.
The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, DJR, DJC, DJG, LCM, LDJ
Device Description
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care settings, Point of Care Use, point-of-care testing, point of care technician
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
Method Comparison - The performance of the QuickScreen™ devices was evaluated with 3 operators who are typical operators at this site. Operators tested 80 unaltered clinical urine samples The samples were blinded and sufficiently randomized and compared to GC/MS results.
Performance of the QuickScreen Drug Screening Test system around cutoff for cocaine (benzoylecgonine) was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 3 technicians in card, cup and cassette formats for a period of 20 days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance: The performance characteristics of the QuickScreen Drug Screening Test system for common analytes was evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen Drug Screening Test system to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine.
Method Comparison - The performance of the QuickScreen™ devices was evaluated with 3 operators who are typical operators at this site. Operators tested 80 unaltered clinical urine samples The samples were blinded and sufficiently randomized and compared to GC/MS results. Results for Cocaine 150 cutoff were: Dipcard (98.75% positive agreement), Cassette (98.75% positive agreement), Cup (98.75% positive agreement), Multi-dip (97.5% positive agreement). All forms showed 100% negative agreement.
Performance of the QuickScreen Drug Screening Test system around cutoff for cocaine (benzoylecgonine) was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 3 technicians in card, cup and cassette formats for a period of 20 days.
Results for Cutoff (150 ng/ml): Multi Card: 12 positive, 68 negative; Cup: 21 positive, 59 negative; Cassette: 15 positive, 65 negative. All concentrations >= 125% showed 100% positive results. All concentrations
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
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FEB - 1 2012 Page 1 of 5
510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)
Manufacturer & Submitter:
Contact:
Phamatech Inc. 10151 Barnes Canyon Road San Diego, California 92121, USA Cari A. Mongiovi Vice President Telephone 858 643 5555 Fax 858 635 5843
1/15/2011 Date Prepared
Proprietary Name: QuickScreen Drug Screening Test System
Common Name: Drug of Abuse Rapid Test System
Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine
Classification Names:
The applicant test system regulatory classification is Class II, Classification Panel is Clinical Toxicology (91). Regulatory information applicable to this test system is provided below:
| CFR section | Product Code | |
|---|---|---|
| 862.3100 | Amphetamine test system | DKZ |
| 862.3150 | Barbiturate test system | DIS |
| 862.3170 | Benzodiazepine test system | JXM |
| 862.3250 | Cocaine/cocaine metabolite test system | DIO |
| 862.3620 | Methadone test system | DJR |
| 862.3610 | Methamphetamine test system | DJC |
| 862.3650 | Opiate test system | DJG |
| 862.3650 | Opiate test system (Oxycodone) | DJG |
| Phencyclidine | LCM | |
| 862.3870 | Cannabinoid test system | LDJ |
Predicate Device: At Home Drug Test Models 9308T and 9308Z
Intended Use:
The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone,
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methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The cut-off concentrations of this test are as follows:
| Analyte | Calibrator | Cutoff |
|---|---|---|
| Amphetamine | d amphetamine | 1000 ng/ml |
| Cocaine | benzoylecgonine | 150 ng/ml |
| • Methamphetamine | d methamphetamine | 500 ng/ml |
| Opiates | morphine | 300 ng/ml |
| PCP | phencyclidine | 25 ng/ml |
| Barbiturates | Secobarbital | 200 ng/ml |
| Benzodiazepines | Oxazepam | 200 ng/ml |
| Methadone | Methadone | 300 ng/ml |
| Oxycodone | Oxycodone | 100 ng/ml |
| THC | Cannabinoids | 50 ng/ml |
The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.
Configurations of the QuickScreen Drug Screening Test System mav consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device.
Similarities and differences to predicate device:
The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home Drug Test and the Phamatech QuickScreen Pro Multi Drug Screening Test. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
| | At Home Test
Model 9308T & 9308Z | QuickScreenTM
Drug Screening Test System |
|----------|-------------------------------------|---------------------------------------------|
| 510(k) # | K070009 | K103295 |
| Format | Integrated Cup/ Dip Card | Integrated Cup/Dip Card/Cassette |
| Use | In vitro diagnostic | In vitro diagnostic |
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| Intended Use | ||
|---|---|---|
| Detection of: | ||
| cocaine (benzoylecgonine) | ||
| THC, | ||
| opiates, | ||
| amphetamine, | ||
| methamphetamine, | ||
| Benzodiazepines, | ||
| barbiturates, | ||
| methadone | ||
| PCP | ||
| OXY | Detection of: | |
| cocaine (benzoylecgonine) | ||
| THC, | ||
| opiates, | ||
| amphetamine, | ||
| methamphetamine, | ||
| Benzodiazepines, | ||
| barbiturates, | ||
| methadone | ||
| PCP | ||
| OXY | ||
| Specimen | Urine | Urine |
| Methodology | Lateral flow Immunoassay | Lateral flow Immunoassay |
| Qualitative | YES | YES |
| Antibodies | Monoclonal / Polyclonal | Monoclonal / Polyclonal |
| Analyte's detected | 10 | 10 |
| Cutoffs (ng/ml) | Cocaine: 300 | |
| THC: 50 | ||
| AMP 1000 | ||
| Opiates: 300 | ||
| PCP: 25 | ||
| MET: 500 | ||
| BZD: 200 | ||
| Barb: 200 | ||
| MTD: 300 | ||
| OXY 100 | Cocaine: 150 | |
| THC: 50 | ||
| AMP 1000 | ||
| Opiates: 300 | ||
| PCP: 25 | ||
| MET: 500 | ||
| BZD: 200 | ||
| Barb: 200 | ||
| MTD: 300 | ||
| OXY 100 | ||
| Incubation | 10 minutes | 10 minutes |
| Control | Control Line | Control Line |
| Features | Test Expired Indicator | Test Expired Indicator |
| End User | Home (OTC) Use | Point of Care Use |
The performance characteristics of the QuickScreen Drug Screening Test system for common analytes are exactly the same. They have not been altered by the change in cutoff concentration of the cocaine test.
See K070009 for amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites. Performance studies were conducted for the change to a 150ng/ml cutoff concentration for cocaine.
The following laboratory performance studies were performed to determine substantial equivalence of the QuickScreen Drug Screening Test system to the predicate:
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Performance: The performance characteristics of the QuickScreen Drug Screening Test system for common analytes was evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen Drug Screening Test system to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine.
Method Comparison - The performance of the QuickScreen™ devices was evaluated with 3 operators who are typical operators at this site. Operators tested 80 unaltered clinical urine samples The samples were blinded and sufficiently randomized and compared to GC/MS results. The results are presented below:
| COC 150 | | Negative
50% of
cutoff | %
Agreement |
|-----------|---|-------------------------------|------------------------------------|-----------------------------------------|---------------------------------------|----------------|
| Dipcard | + | | 1 | 17 | 28 | 98.75 |
| | - | 20 | 19 | | | 100 |
| Cassette | + | | 1 | 16 | 28 | 98.75 |
| | - | 20 | 19 | | | 100 |
| Cup | + | | 1 | 16 | 28 | 98.75 |
| | - | 20 | 19 | | | 100 |
| Multi-dip | + | | 2 | 16 | 28 | 97.5 |
| | - | 24 | 18 | | | 100 |
| Cutoff Value
(ng/ml) | Phamatech COC150
(Pos/Neg) | Drug/Metabolite
GC/MS value (ng/ml) |
|-------------------------|-------------------------------|----------------------------------------|
| 150 | Positive (card) | 147.1 |
| | | 148.16 |
| 150 | Positive (cup) | 144 |
| 150 | Positive (card) | 144 |
Performance of the QuickScreen Drug Screening Test system around cutoff for cocaine (benzoylecgonine) was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 3 technicians in card, cup and cassette formats for a period of 20 days. The results are summarized below:
| CONCENTRATION
| (ng/ml) | Multi Card | Cup | Cassette | |||
|---|---|---|---|---|---|---|
| Negative | 40 | 0 | 40 | 0 | 40 | 0 |
| -75% | 80 | 0 | 80 | 0 | 80 | 0 |
| -50% | 80 | 0 | 80 | 0 | 80 | 0 |
Sensitivity / Precision at 4 sites:
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| -25% | 80 | 0 | 80 | 0 | 80 | 0 |
|---|---|---|---|---|---|---|
| Cutoff | 12 | 68 | 21 | 59 | 15 | 65 |
| 125% | 0 | 80 | 0 | 80 | 0 | 80 |
| 150% | 0 | 80 | 0 | 80 | 0 | 80 |
| 175% | 0 | 80 | 0 | 80 | 0 | 80 |
| 200% | 0 | 80 | 0 | 80 | 0 | 80 |
Other technical performance tests include:
Assay Interference - Negative base Assay Interference – Positive base Lot to Lot Consistency Prozone Response Effect of Sample pH Test Strip Dip Time Flex Read Time Flex Sample Temperature Flex Specific Gravity Effects Format Equivalency
For the reasons mentioned above, it may be concluded that Conclusion: Phamatech's QuickScreen Drug Test system is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the point of care technician.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.
10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 0 1 2012
PHAMATECH INC
c/o Carl Mongiovi 10151 Barnes Canyon Rd San Diego. CA 92121
Re: K103295
Trade Name: Quickscreen Cocaine 150 Test, Quickscreen Multi Drug Screening Test, Quickscreen Drug Cup Test Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO Dated: September 14, 2011 Received: January 18, 2012
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
signature
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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): _K_103295 . _
Device Name: QuickScreen™ Cocaine 150 Test Model 9050T Dip Card and 9051 Cassette
Indications for Use:
The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other 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.
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
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
513(a) K103295
175
ા W
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Page 1 of 1
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _K_103295 .
Device Name: QuickScreen™ Multi Drug Screening Test Model 9339T Dip Card
Indications for Use:
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
| Analyte | Calibrator | Cutoff |
|---|---|---|
| Amphetamine | d amphetamine | 1000 ng/ml |
| Cocaine | benzoylecgonine | 150 ng/ml |
| Methamphetamine | d methamphetamine | 500 ng/ml |
| Opiates | morphine | 300 ng/ml |
| PCP | phencyclidine | 25 ng/ml |
| Barbiturates | Secobarbital | 200 ng/ml |
| Benzodiazepines | Oxazepam | 200 ng/ml |
| Methadone | Methadone | 300 ng/ml |
| Oxycodone | Oxycodone | 100 ng/ml |
| THC | Cannabinoids | 50 ng/ml |
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other 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.
Prescription Use: AND/OR X (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 Sian-Off
Office of In Vitin Diagnostic Device Evaluation and Safety
57021 K103295
176
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Page 1 of 1
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _K 103295
Device Name: QuickScreen™ Drug Cup Model 9339Z
Indications for Use:
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone, oxycodone and THC in urine. Tests for barbiturates camot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
| Analyte | Calibrator | Cutoff |
|---|---|---|
| Amphetamine | d amphetamine | 1000 ng/ml |
| Cocaine | benzoylecgonine | 150 ng/ml |
| Methamphetamine | d methamphetamine | 500 ng/ml |
| Opiates | morphine | 300 ng/ml |
| PCP | phencyclidine | 25 ng/ml |
| Barbiturates | Secobarbital | 200 ng/ml |
| Benzodiazepines | Oxazepam | 200 ng/ml |
| Methadone | Methadone | 300 ng/ml |
| Oxycodone | Oxycodone | 100 ng/ml |
| THC | Cannabinoids | 50 ng/ml |
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other 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.
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use: AND/OR (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) | K103295 |
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