(36 days)
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. 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 III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in 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).
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) clearance letter for a drug screening device, not a detailed study report. Therefore, much of the requested information (like specific sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this type of regulatory correspondence. The document focuses on the intended use and performance characteristics as claimed by the manufacturer and accepted by the FDA based on a comparison to predicate devices, rather than a detailed accounting of a specific clinical performance study.
However, I can extract the acceptance criteria as presented for each drug panel.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for each drug are defined by the "Cutoff (ng/ml)" concentration. The device is expected to qualitatively detect the presence of the specified drug at or above these cutoff concentrations. The document does not provide a table of reported device performance in terms of sensitivity, specificity, accuracy, or concordance with a gold standard from a specific study within this letter. Instead, it states the intended use is for qualitative detection relative to these cutoffs.
| Test | Calibrator | Cutoff (ng/ml) (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Cocaine metabolite (COC) | Benzoylecgonine | 300 | Not provided in this document |
| Tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-COOH | 50 | Not provided in this document |
| Methamphetamine (MET1000) | Methamphetamine | 1000 | Not provided in this document |
| Opiates (OPI) | Morphine | 2000 | Not provided in this document |
| Phencyclidine (PCP) | Phencyclidine | 25 | Not provided in this document |
| Amphetamine (AMP) | Amphetamine | 1000 | Not provided in this document |
| Barbiturates (BAR) | Secobarbital | 300 | Not provided in this document |
| Benzodiazepines (BZO) | Oxazepam | 300 | Not provided in this document |
| Methadone (MTD) | Methadone | 300 | Not provided in this document |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 | Not provided in this document |
| Oxycodone (OXY) | Oxycodone | 100 | Not provided in this document |
| 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500 | Not provided in this document |
Specific Study Information (Based on available document content):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Typically, for in vitro diagnostic devices, studies involve spiked urine samples and/or clinical urine samples. The document does not state country of origin or if prospective/retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For in vitro diagnostic assays, ground truth is typically established by definitive analytical methods (like GC/MS) rather than expert consensus on visual interpretation.
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Adjudication method for the test set:
- Not applicable/Not specified. This refers to consensus among human readers for image interpretation, which is not relevant for this type of qualitative chemical test.
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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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images. It is a rapid qualitative immunoassay.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable. The device is a standalone qualitative test. The "output" is a visual indication (e.g., lines on a strip). However, the document states, "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." This indicates that while the device itself performs the detection without human intervention, its results require expert clinical interpretation and confirmation by a more specific method.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ultimate ground truth for confirmation is a "more specific alternate chemical method," with "Gas Chromatography/Mass Spectroscopy (GC/MS) [being] the preferred confirmation method."
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The sample size for the training set:
- Not specified in this document. Immunoassays are often "trained" or optimized during development using various concentrations of analytes and interferents, but this is a manufacturing/development process, not typically reported with a "training set" size in the same way as an AI algorithm.
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How the ground truth for the training set was established:
- Not specified in this document. As with the test set, it would typically involve spiking known concentrations of drugs into urine samples or using characterized clinical samples, with definitive analytical methods (like GC/MS) used to establish the true concentration/presence.
Summary of Device and Approval Context:
This FDA 510(k) clearance letter indicates that the Ameditech ImmuTest Multi-Drug Screen Panel III is a qualitative in-vitro diagnostic device for detecting multiple drugs in human urine. Its "acceptance criteria" are the specified cutoff concentrations for each drug metabolite. The FDA determined that this device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance, safety, and effectiveness are considered comparable. The letter does not provide a detailed clinical study report but rather acts as regulatory approval based on the manufacturer's submission demonstrating substantial equivalence. The "study" mentioned generally refers to the performance data submitted by the manufacturer to demonstrate this substantial equivalence to predicate devices, which would have included data to support the stated cutoffs and qualitative detection capabilities.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 4 - 2005
John Wu, Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe Suite F San Diego, CA 92121
Re: K050186
Trade/Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM Dated: January 21, 2005 Reccived: January 28, 2005
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) This letter will anow you to oogin maneting of substantial equivalence of your device to a legally premarket notification: "The PDs 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 or quottons on the promie Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I bu may oount oner getierers, 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,
Jean M. Cooper, MS, DVM
Jean M. Cooper, MS, D.V.M. 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):
Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III
Indications For Use:
The Ameditech ImmuTest Multi-Drug Screen Panel III 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) |
|---|---|---|
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET1000) | Methamphetamine | 1000 |
| Opiates (OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Methadone (MTD) | Methadone | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| 3,4methylenedioxymethamphetamine(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
This test uses multiple test strips in 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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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).