(251 days)
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Not Found
No
The description focuses on immunochromatographic test strips and does not mention any AI/ML components or image processing.
No
The device is a diagnostic test system used to detect drugs in urine, not to treat a medical condition.
Yes
The device is intended for the "rapid, qualitative detection" of various drugs in human urine, which is a diagnostic function used to identify the presence of specific substances. The indicated uses in "drug rehabilitation clinics, physician offices, and laboratory settings" further support its diagnostic application.
No
The device description explicitly states it uses "immunochromatographic test strips," which are physical hardware components used for chemical analysis. This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It is intended for use on human specimens: The intended use states it detects substances in "human urine."
- It is used to provide information about a physiological state: Detecting drugs of abuse in urine provides information about whether a person has recently used those substances, which relates to their physiological state.
- It is used in a laboratory or other healthcare setting: The intended use specifies "prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings."
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device fits that description.
N/A
Intended Use / Indications for Use
"The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale."
Product codes (comma separated list FDA assigned to the subject device)
DKZ, JXM, LDJ, DIO, DJR, DJC, DJG, LCM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
"Operators that may use this device are defined as individuals with a minimum of a high school education with no formal laboratory training or experience. Individuals should also satisfy the following training and certification guidelines: (1)Training should be conducted by a qualified professional and include a demonstration of the SURE-SCREEN test system and (2) the use of quality assurance samples for monitoring and confirming the performance of the test system. Trainers should observe and confirm that the operator (3) uses proper technique when running a test sample and quality assurance samples, (4) has a basic understanding of test results, including a the potential for false positive and false negative results, (5) knows how to prepare a sample for shipment to the laboratory for confirmation testing, (6) has reviewed the information contained in the MEDTOX SURE-SCREEN Training and Certification Program (available at www.medtox.com and that the operator (7) minimally achieves a score of 80% on the written exam provided by MEDTOX .
Operators achieving a score of 80% will be provided with a certificate of train participation. Quality assurance samples appropriate for training are available from MEDTOX Laboratories Inc. Additionally, MEDTOX Technical Suppo provide access to assistance from individuals who are experienced in interpretation of drug testing results."
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Alan Morris Manager, Product Development Medtox Diagnostics, Inc. 1238 Anthony Rd. Burlington, NC 27215
K050394 Re:
Trade/Device Name: Sure-Screen® Amphetamine, Sure-Screen® Benzodiazepine, Sure-Screen® Methamphetamine, Sure-Screen® Methadone, Sure-Screen® Opiate, Sure-Screen® Phencyclidine and Sure-Screen® Cannabinoids Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, JXM, LDJ, DIO, DJR, DJC, DJG, LCM Dated: August 31, 2005 Received: September 1, 2005
OCT 2 5 2005
Dear Mr. Morris:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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,
Carol C. Benam
Carol C. Benson, M.A. 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
510(k) Number (if known):
Sure-Screen® Amphetamine, Sure-Screen ® Benzodiazepine, Sure-Device Name: Screen® Cocaine, Sure-Screen® Methamphetamine, Sure-Screen® Methadone, Sure-Screen® Opiate, Sure-Screen® Phencyclidine and Sure-Screen® Cannabinoids
Indications For Use:
The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale.
Operators that may use this device are defined as individuals with a minimum of a high school education with no formal laboratory training or experience. Individuals should also satisfy the following training and certification guidelines: (1)Training should be conducted by a qualified professional and include a demonstration of the SURE-SCREEN test system and (2) the use of quality assurance samples for monitoring and confirming the performance of the test system. Trainers should observe and confirm that the operator (3) uses proper technique when running a test sample and quality assurance samples, (4) has a basic understanding of test results, including a the potential for false positive and false negative results, (5) knows how to prepare a sample for shipment to the laboratory for confirmation testing, (6) has reviewed the information contained in the MEDTOX SURE-SCREEN Training and Certification Program (available at www.medtox.com and that the operator (7) minimally achieves a score of 80% on the written exam provided by MEDTOX .
Operators achieving a score of 80% will be provided with a certificate of train participation. Quality assurance samples appropriate for training are available from MEDTOX Laboratories Inc. Additionally, MEDTOX Technical Suppo provide access to assistance from individuals who are experienced in interpretation of drug testing results.
Sure-Screen detects drug classes at the following cutoff concentration
(AMP) Amphetamines (d-Amphetamine)
300 ng/t
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| (BZO) Benzodiazepines (Nordiazepam) | 200 ng/mL |
|---|---|
| (COC) Cocaine (Benzoylecgonine) | 100 ng/mL |
| (MAMP) Methamphetamine (d-Methamphetamine) | 300 ng/mL |
| (MTD) Methadone (Methadone) | 200 ng/mL |
| (OPI) Opiates (Morphine) | 100 ng/mL |
| (PCP) Phencyclidine (Phencyclidine) | 25 ng/mL |
| (THC) Cannabinoids (11-nor-9-carboxy-Δ9-THC) | 40 ng/mL |
Many of the cutoff concentrations for these tests are below those recommended by SAMHSA. Additionally, many of these tests are positive at levels significantly below the claimed cutoff concentration. The rate of false positive results with tests having sensitivities this low has not been studied. However, the rate of false positives generally increases as the cutoff concentration of the test is lowered. See the Precision/Sensitivity section for more information.
The SURE-SCREEN drugs of abuse test system provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.
It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.
Prescription Use ) (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Larry Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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