(24 days)
The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative detection of 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.
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Here's a breakdown of the acceptance criteria and study information for the Ameditech DrugSmartCup™ based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA letter does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity thresholds). However, it implies that the device's performance, as demonstrated in the submission, was deemed substantially equivalent to legally marketed predicate devices. The listed "Indications for Use" and the table of "Cutoff concentrations" define the intended analytical performance of the device.
| Test | Calibrator | Cutoff (ng/ml) |
|---|---|---|
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET) | Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Opiates (OPI2000) | Morphine | 2000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Tetrahydrocannabinol (THC) | 11-nor- $\Delta^9$ -THC-9-COOH | 50 |
Reported Device Performance: The document only states that the device was found "substantially equivalent" to legally marketed predicate devices for the specified indications. It does not provide specific performance metrics like sensitivity, specificity, or accuracy percentages from Ameditech's study. The cutoff concentrations in the table are the definition of the expected performance for a positive/negative result.
2. Sample Size Used for the Test Set and Data Provenance
The provided FDA letter does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail would typically be found in the 510(k) submission itself, not the FDA's decision letter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided FDA letter does not contain information about the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The provided FDA letter does not specify any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not applicable to this type of in-vitro diagnostic device (a qualitative screen test for drugs in urine). MRMC studies are typically used for imaging diagnostics where human readers interpret results. This device produces a visual, qualitative result that is read directly, not interpreted by multiple human readers in a comparative setting against an AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this device inherently functions as a standalone test. It's an "In Vitro screen test device for the qualitative detection of drugs in human urine" that provides a "visual, qualitative result." While human eyes read the result, there is no separate "algorithm" being evaluated against human-in-the-loop performance in the way an AI algorithm for medical imaging would be. The device itself is the "algorithm" in a chemical sense.
7. The Type of Ground Truth Used
The ground truth for a drug screening device like this would typically be established by a more definitive analytical method. 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, GC/MS is the type of ground truth used to determine the actual presence and concentration of drugs to validate the device's accuracy.
8. The Sample Size for the Training Set
The provided FDA letter does not contain information regarding the sample size used for any training set. This device is not an AI/ML algorithm that is "trained" in the typical sense; it is a chemical immunoassay.
9. How the Ground Truth for the Training Set Was Established
As this is a chemical immunoassay rather than a machine learning algorithm requiring a "training set" in the AI sense, this question is not directly applicable. However, if this refers to the development and calibration of the assay, the "ground truth" for calibrating the device would involve spiking urine samples with known concentrations of the target analytes and confirming those concentrations with a gold standard like GC/MS to ensure the device correctly identifies positive/negative relative to the established cutoffs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2005 DEC 8
John Wu, Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe, Suite F San Diego, CA 92121
K053175 Re: Trade/Device Name: Ameditech DrugSmartCup™ Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class. Class II
Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM Dated: November 10, 2005 Received: November 16, 2005
Dear Dr. Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications felerenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manated profite Amedical Device Amendments, or to commerce prior to May 28, 1776, the enacement auth the provisions of the Federal Food, Drug, devices that have been recalismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merciole, market the device, soloje requirements for annual registration, listing of general controls provisions of the ree, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 vo) including major regulations affecting your device It may be subject to Such additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Cour cannouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA 3 issuation of a basedianal with other requirements of the Act mat I DA has made a decerminations administered by other Federal agencies. You must of ally it catal statutes and regaranents and limited to: registration and listing (21 Comply with an the Tree Frequirents, one of and 809); and good manufacturing practice and 800) CTN Part 807), laoemig 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 his icher will anow you to oegin maxicang your device of your device to a legally premarket notification: "The PDT interly on 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, If you desire specific infortion and advertising of your device, please contact the Office of In of quotions on the promotion and Safety at (240) 276-0484. Also, please note the viro Diaghebited "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other generational 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 vours,
Alberto G
Alberto Gutierrez, Ph.D. 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
Indications for 350 Koss 3175
510(k) Number (if known): K053175
Device Name: Ameditech DrugSmartCup™
Indications For Use:
The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative The Amedited Drugs in human urine. The cutoff concentrations for this test are as follows.
| Test | Calibrator | Cutoff(ng/ml) |
|---|---|---|
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET) | Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Opiates (OPI2000) | Morphine | 2000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Tetrahydrocannabinol (THC) | 11-nor- $\Delta^9$ -THC-9-COOH | 50 |
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 I his ussay provides only drug of abuse test result, particularly in evaluating a juaghen mast ve uppersult. In order to obtain a confirmed analytical result, a more precific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Over-The-Counter Use AND/OR Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Bernoon
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
C9(k) K053175
§ 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).