(136 days)
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No
The description details a standard lateral flow immunoassay and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic test used for screening for drugs of abuse; it does not treat or prevent any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This indicates its purpose is to aid in diagnosis by providing screening results for drugs of abuse.
No
The device description clearly indicates it is a "lateral flow competitive immunoassay panel or single test," which is a physical, hardware-based diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated: The document includes the phrase "For in vitro diagnostic use only." This is a clear indication that the device is intended for use outside of the body to diagnose conditions.
- Intended Use: The intended use describes the device as a "lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or to determine the state of health.
- Specimen Type: The test is performed on urine, which is a specimen derived from the human body.
- Purpose: The purpose is to provide "qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine." This information is used in a diagnostic context (screening for the presence of these substances).
Therefore, based on the provided information, the One Step Drugs of Abuse Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.
For in vitro diagnostic use only.
As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Product codes
DKZ, LDJ, DIO, DIO, DPK
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
professional central laboratory use by trained users
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)
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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.
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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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the body, wings, and tail feathers. The text is in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jason Peng Regulatory Affairs Manager IND Diagnostic, Inc. 1629 Fosters Way Delta, B.C V3M 6S7 Canada
AUG - 7 2006
Re: K060810
Trade/Device Name: One Step DOA-2, DOA-4 Multi-Panel Test One Step Amphetamine Test- Cassette and Strip Formats One Step Methamphetamine Test- Cassette and Strip Formats One Step Cocaine Test- Cassette and Strip Formats One Step Morphine Test- Cassette and Strip Formats One Step Marijuana Test- Cassette and Strip Formats Regulation Number: 21 CFR §862.3100 Amphetamine Test System Regulation Name: Regulatory Class: Class II
Product Code: DKZ, LDJ, DIO, DIO, DPK Dated: June 29, 2006
Received: July 3, 2006
Dear Mr. Peng:
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 r reaso be acribed 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 or any vith 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) 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 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Garcia
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):
KOGO810
Device Name:
One Step DOA-2, DOA-3, DOA-4, DOA-5 Multi Panel Test One Step Amphetamine Test - Cassette and Strip Formats One Step Methamphetamine Test - Cassette and Strip Formats One Step Cocaine Test - Cassette and Strip Formats One Step Morphine Test - Cassette and Strip Formats One Step Marijuana Test - Cassette and Strip Formats
Indications For Use:
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.
For in vitro diagnostic use only.
As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory 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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Office of In Vitro Diagnostic Device Evaluation and Safety
si(k) K060810
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