(174 days)
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
| Compound | TestAbbreviation | Level (ng/ml) |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 |
| Barbiturates (secobarbital) | BAR | 300 |
| Benzodiazepine (oxazepam) | BZO | 300 |
| Cocaine (benzoylecgonine) | COC | 300 |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 |
| Methadone | MTD | 300 |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 300 |
| 2000 | ||
| Oxycodone | OXY | 100 |
| Phencyclidine (phencyclidine HCI) | PCP | 25* |
| Propoxyphene/Norpropoxyphene | PPX | 300 |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 |
Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
The provided document describes the FDA 510(k) clearance for the RapidTox™ device, a lateral flow immunoassay for detecting drugs of abuse in urine. However, it does not contain explicit information regarding acceptance criteria, a detailed study design, or specific performance metrics (like sensitivity, specificity, accuracy) derived from such a study.
The document primarily focuses on the regulatory submission and FDA's determination of substantial equivalence to predicate devices, along with the device's intended use and detection levels for various substances.
Therefore, many of the requested details cannot be extracted directly from this document. I will fill in what can be inferred or stated based on the given text and indicate where information is missing.
Acceptance Criteria and Device Performance (Inferred/Not Explicitly Stated)
The document lists the detection levels for various compounds. For a lateral flow immunoassay in a regulatory context, acceptance criteria would typically revolve around demonstrating that the device can accurately detect these compounds at or above the specified cutoff levels (sensitivity) and not produce false positives in the absence of the drug (specificity).
Table of (Inferred) Acceptance Criteria and Device Performance
| Compound | Test Abbreviation | Target Cutoff Level (ng/ml) | Reported Performance (Inferred from device's function as a "qualitative detection" at specified levels) |
|---|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 | Qualitatively detects Amphetamine at or above 1000 ng/ml. |
| Barbiturates (secobarbital) | BAR | 300 | Qualitatively detects Barbiturates at or above 300 ng/ml. |
| Benzodiazepine (oxazepam) | BZO | 300 | Qualitatively detects Benzodiazepine at or above 300 ng/ml. |
| Cocaine (benzoylecgonine) | COC | 300 | Qualitatively detects Cocaine at or above 300 ng/ml. |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 | Qualitatively detects MDMA at or above 1000 ng/ml. |
| Methadone | MTD | 300 | Qualitatively detects Methadone at or above 300 ng/ml. |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 | Qualitatively detects Methamphetamine at or above 1000 ng/ml. |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 2000 | Qualitatively detects Opiates at or above 2000 ng/ml. |
| Oxycodone | OXY | 100 | Qualitatively detects Oxycodone at or above 100 ng/ml. |
| Phencyclidine (phencyclidine HCl) | PCP | 25* | Qualitatively detects Phencyclidine at or above 25 ng/ml. |
| Propoxyphene/Norpropoxyphene | PPX | 300 | Qualitatively detects Propoxyphene/Norpropoxyphene at or above 300 ng/ml. |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* | Qualitatively detects THC/Cannabinoids at or above 50 ng/ml. |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 | Qualitatively detects Tricyclic Antidepressants at or above 1000 ng/ml. |
Note: The actual acceptance criteria (e.g., minimum sensitivity and specificity percentages) for the study are not specified in this document, only the target detection levels.
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For drug tests, ground truth is typically established by a gold standard laboratory method.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Adjudication methods are typically used when subjective expert interpretation is involved. For a diagnostic test like this, a confirmatory objective method is usually employed as the ground truth.
-
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. The RapidTox™ is a lateral flow immunoassay, a diagnostic device that produces a visual result (lines) for drug detection. It is not an AI-powered system, nor does it involve human "readers" in the sense of image interpretation where an AI would assist. Its interpretation is generally objective based on the presence or absence of a line.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As noted above, this is not an AI algorithm. Its performance is inherent to the chemical reactions and design of the immunoassay itself in detecting the target analytes. The device is standalone in the sense that it provides a direct qualitative result without further interpretation by an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
- Therefore, the ground truth used for validating the immunoassay would be GC/MS (Gas Chromatography/Mass Spectrometry), which is an objective, highly accurate analytical method for drug identification and quantification.
-
The sample size for the training set:
- Not Applicable. This is a traditional immunoassay, not a machine learning or AI model, so there is no "training set" in the computational sense. The device's performance is developed and optimized through chemical formulation and engineering, not algorithm training.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply to this device. The 'ground truth' for the development and validation of the immunoassay itself (e.g., establishing the reactivity of antibodies, optimizing cutoff levels) would be based on precise laboratory measurements using known concentrations of analytes and reference methods like GC/MS.
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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 consists of a stylized depiction of an eagle or bird-like figure with flowing lines, positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the emblem. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2006
American BIO Medica Corp. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K053359
Trade/Device Name: RapidToxTM Regulation Number: 21 CFR§ 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM Dated: May 9, 2006 Received: May 11, 2006
Dear Ms. White:
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. Yourmust 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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Page 2 --
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 @ - (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
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
510(k) Number (if known): KOE33EA
RapidTox™ Device Name:
Indications For Use: "
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
| Compound | TestAbbreviation | Level (ng/ml) |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 |
| Barbiturates (secobarbital) | BAR | 300 |
| Benzodiazepine (oxazepam) | BZO | 300 |
| Cocaine (benzoylecgonine) | COC | 300 |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 |
| Methadone | MTD | 300 |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 300 |
| 2000 | ||
| Oxycodone | OXY | 100 |
| Phencyclidine (phencyclidine HCI) | PCP | 25* |
| Propoxyphene/Norpropoxyphene | PPX | 300 |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 |
Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.
| Prescription Use(Part 21 CFR 801 Subpart D) | √ |
|---|---|
| ------------------------------------------------- | --- |
| A | |
|---|---|
| --- | -- |
ND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. . . . . . . . . . . . . . . .
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K053359 |
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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).