(251 days)
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.
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.
Here's an analysis of the provided text regarding the Sure-Screen® Drugs of Abuse Test System, focusing on acceptance criteria, study details, and ground truth establishment:
Disclaimer: The provided text is a 510(k) premarket notification letter and the "Indications for Use" section. It's important to note that this document describes the device and its intended use, but it does not contain a detailed study report that would typically include comprehensive acceptance criteria, specific performance metrics, or a breakdown of a validation study with sample sizes, expert qualifications, or adjudication methods in the granular detail requested. The information below is extracted and inferred from the provided text to the best extent possible.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "cutoff concentrations" which act as a key performance criterion for qualitative drug tests. The device's performance is described in terms of its ability to detect these drug classes at or below these specified cutoffs.
| Drug Class (Analyte) | Acceptance Criterion (Cutoff Concentration) | Reported Device Performance (Implied) |
|---|---|---|
| Amphetamines (d-Amphetamine) | 300 ng/mL | Detects at 300 ng/mL |
| Benzodiazepines (Nordiazepam) | 200 ng/mL | Detects at 200 ng/mL |
| Cocaine (Benzoylecgonine) | 100 ng/mL | Detects at 100 ng/mL |
| Methamphetamine (d-Methamphetamine) | 300 ng/mL | Detects at 300 ng/mL |
| Methadone (Methadone) | 200 ng/mL | Detects at 200 ng/mL |
| Opiates (Morphine) | 100 ng/mL | Detects at 100 ng/mL |
| Phencyclidine (Phencyclidine) | 25 ng/mL | Detects at 25 ng/mL |
| Cannabinoids (11-nor-9-carboxy-Δ9-THC) | 40 ng/mL | Detects at 40 ng/mL |
Note on "Reported Device Performance": The document states these are the "cutoff concentrations" at which the device detects the drug classes. It also mentions: "Additionally, many of these tests are positive at levels significantly below the claimed cutoff concentration." This implies that the device is at least as sensitive as, if not more sensitive than, the stated cutoffs. However, specific sensitivity or specificity percentages against a ground truth are not provided in this document excerpt.
Regarding the Study (Based on available information):
Since this is a 510(k) premarket notification, the FDA determination of "substantial equivalence" is based on the comparison of the device to legally marketed predicate devices. The document implies that performance claims for the Sure-Screen® system were evaluated, but it does not provide a detailed study report regarding a specific clinical trial or validation study with all the requested parameters.
Here’s what can be inferred/not inferred:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It would typically involve urine samples, but the source and collection methodology are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document states that "Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method." This implies that experts in analytical chemistry or laboratory professionals proficient in these techniques would be involved in establishing the ground truth. No specific number or credential level (e.g., "radiologist with 10 years of experience") is mentioned for clinical interpretation, as the test is primarily analytical.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. For analytical tests like this, adjudication typically refers to the process of confirming results using a gold standard method (GC/MS or LC/MS/MS) rather than expert consensus on visual interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable to this device as described. This is an in vitro diagnostic qualitative rapid test for drug detection, not an AI-powered diagnostic imaging tool that requires human reader interpretation with or without AI assistance. The document refers to "operators" who use the device, but their "improvement with AI" is not a relevant metric here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: This device is a manual, qualitative immunoassay test strip. It doesn't involve an "algorithm" in the sense of AI. Its performance is inherent to the chemical reactions on the strip. The "operators" interpret the visual results. The performance would implicitly be its standalone analytical performance against the cutoff concentrations, but not in the context of an "algorithm."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The document explicitly states: "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."
- Therefore, the ground truth is chemical confirmation using gold-standard analytical methods (GC/MS or LC/MS/MS), which would be interpreted by qualified laboratory personnel.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. For this type of immunoassay, there wouldn't typically be a "training set" in the machine learning sense. Instead, product development involves optimizing reagents and concentrations, and then validating performance with a series of samples. If "training set" refers to samples used during product development and optimization, that information is not provided.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Similar to point 8, the concept of a "training set" with ground truth as used in AI development is not directly applicable. If samples were used during development to optimize the test's performance, the ground truth for those samples would also be established by reference laboratory methods like GC/MS or LC/MS/MS.
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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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§ 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).