(62 days)
The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | Cutoff(ng/ml) |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.
This document is a 510(k) clearance letter for an in vitro diagnostic device, the Ameditech ImmuTest Multi-Drug Screen Panel II. It does not contain the detailed study information typically found in a clinical trial report or a scientific paper. Therefore, I cannot provide a complete answer to your request based solely on the provided text.
However, I can extract the acceptance criteria and some limited information about the device performance and how the ground truth is established, based on what's available in the "Indications for Use" section.
Here's what I can infer and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The "Indications for Use" section lists the cutoff concentrations for each drug panel. These are the established thresholds for a positive result in this qualitative screen test. While the document doesn't explicitly state "acceptance criteria" for the device's performance (e.g., sensitivity, specificity, accuracy), the cutoff concentrations themselves are a critical part of its intended performance. The document only specifies the design of the test (i.e., its cutoff values), not the performance against clinical samples.
| Test | Calibrator | Cutoff (ng/ml) |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
The document states, "This assay provides only a preliminary result." This implies that the device's performance, while meeting regulatory requirements for a screening test, is not definitive and requires confirmation.
Missing Information: The provided text does not contain any data on the device's actual performance (e.g., sensitivity, specificity, accuracy) from a study against these cutoffs. Therefore, I cannot fill in a "Reported Device Performance" column with actual study results.
2. Sample size used for the test set and the data provenance
Missing Information: This document does not provide any details about the sample size used for performance testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in a separate study report or the 510(k) submission itself, not in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This device is an in vitro diagnostic test for drug screening. The "ground truth" for such tests is typically established through a "more specific alternate chemical method," as stated in the document. Therefore, human experts (like radiologists) are not involved in establishing the ground truth for the test set in this context.
4. Adjudication method for the test set
Missing Information: Not applicable, as human experts are not involved in establishing the ground truth for this type of device. The adjudication method refers to how disagreements among human readers are resolved.
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
Not Applicable: This is an in vitro diagnostic device, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study and effects of AI assistance for human readers are irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The device is described as "an In Vitro screen test device for the qualitative detection of multi-drugs in human urine." It provides "a visual, qualitative result" and is "intended for professional use." This strongly suggests it's a standalone test (algorithm only, in the sense of the chemical reactions on the strip providing the result) that is interpreted by a professional, rather than an AI that acts as an adjunct to a human.
The statement "This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result" highlights that while the device is standalone in generating a result, human judgment is critical for its clinical application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document explicitly states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method."
Therefore, the type of ground truth used for validating the performance of this preliminary screening device would be Gas Chromatography/Mass Spectroscopy (GC/MS) or another highly specific chemical analytical method. This is the gold standard for confirming the presence and concentration of drugs in biological samples.
8. The sample size for the training set
Missing Information: This document does not provide details about a "training set." For in vitro diagnostic devices, the development process might involve numerous experiments and optimization steps, but the concept of a "training set" as used in machine learning (which often implies a distinct, labeled dataset for algorithm development) isn't directly applicable or described here.
9. How the ground truth for the training set was established
Missing Information: As mentioned above, the concept of a "training set" in the context of AI is not directly applicable here. If referring to the internal development process of the assay, the ground truth would similarly be established by highly accurate analytical methods like GC/MS to calibrate and validate the chemical reactions on the test panel.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three heads.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 2004
John Wu, Ph.D. Director of Quality Assurance Ameditech Inc. 10340 Camino Sante Fe Suite F San Diego, CA 92121
Re: K042975 .
Trade/Device Name: Ameditech ImmuTest Multi-Drug Screen Panel II Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, JXM, DJR, LAF, DJG Dated: October 26, 2004 Received: October 28, 2004
Dear Dr. Wu:
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) I mis lotter will and my you to 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,
acting
Cornelia 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
510(k) Number (if known): k 042975
Device Name: Ameditech ImmuTest Multi-Drug Screen Panel II
Indications For Use:
The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | Cutoff(ng/ml) |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Prescription Use X (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)
Office of In Vitro Diagnostic Devices (OIVD) Concurrence of
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluatio
Page 1 of 1
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).