(174 days)
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No
The device description and intended use clearly define it as a lateral flow immunoassay, which is a chemical-based test and does not involve AI/ML. There is no mention of any computational analysis or algorithms.
No.
The device is described as a diagnostic tool for drug detection, not for treating or rehabilitating patients.
Yes
The device detects specific analytes (drugs of abuse) in human urine, providing a preliminary analytical test result that indicates the presence or absence of these substances. This function falls under the definition of a diagnostic device as it aids in identifying a condition or state (drug presence).
No
The device description explicitly states it is a "lateral flow immunoassay," which is a hardware-based test strip, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "simultaneous detection of up to ten abused drug analytes in urine." This involves testing a biological sample (urine) in vitro (outside the body) to obtain information about a person's health status (presence of drugs of abuse).
- Device Description: The description confirms it's a "lateral flow immunoassay," which is a common type of in vitro diagnostic test.
- Professional Use: While it's intended for professional use, this doesn't preclude it from being an IVD. Many IVDs are designed for use by healthcare professionals.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description by testing urine for the presence of drugs of abuse.
N/A
Intended Use / 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 | Test Abbreviation | 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 |
| Oxycodone | OXY | 2000 |
| Phencyclidine (phencyclidine HCI) | PCP | 100 |
| Propoxyphene/Norpropoxyphene | PPX | 25* |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 300 |
| Tricyclic Antidepressants (nortriptyline) | TCA | 50* |
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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM
Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
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
2
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 | Test
Abbreviation | 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)
. . . . . . . . . . . . . . . .
{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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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