(112 days)
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No
The document describes a standard ELISA test, which is a biochemical assay and does not involve AI or ML. There are no mentions of AI, ML, or related concepts.
No.
The device is an in vitro diagnostic device used for the qualitative detection of methamphetamine in oral fluid samples, not for therapeutic purposes.
Yes
The document explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only."
No
The device description clearly states it is an "ELISA test system" and utilizes an "Enzyme Linked Immunoassay," which are laboratory-based chemical and biological processes requiring physical reagents and equipment, not solely software. It also mentions an "ORAL FLUID COLLECTION DEVICE," which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This in vitro diagnostic device is intended for clinical laboratory use only."
- Nature of the Test: The device performs an ELISA test on oral fluid samples to detect a substance (methamphetamine). This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide information about a person's health or condition (in this case, the presence of a drug).
- Intended Use: The intended use is for "clinical laboratory use," which is a common setting for IVD devices.
N/A
Intended Use / Indications for Use
The Immunalysis Methamphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of methamphetamine in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY using a cutoff of 50 ng/mL of d-methamphetamine. This in vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Methamphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method . Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
LAF
Device Description
Immunalysis Methamphetamine ELISA for Oral Fluids
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
Oral Fluids
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory 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)
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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
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§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael Vincent V.P. Operations Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767
Re: K051577
Trade/Device Name: Immunalysis Methamphetamine ELISA for Oral Fluids Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: August 10, 2005 Received: August 23, 2005
Dear Mr. Vincent:
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) 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,
Carol C. Benson
Carol C. Benson, M.A. Acting 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): K051577
Device Name: Immunalysis Methamphetamine ELISA for Oral Fluids
Indications For Use:
The Immunalysis Methamphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of methamphetamine in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY using a cutoff of 50 ng/mL of d-methamphetamine. This in vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Methamphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method . Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
メ Prescription Use (Part 21 CFR 801 Subpart D)
AND/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)
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Salety
510(k) K051577
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