IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS by Immunalysis Corporation

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.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic device, specifically the "Immunalysis Methamphetamine ELISA for Oral Fluids." It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and the study that proves the device meets those criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It also includes the "Indications for Use," which specifies what the device is intended for and its cutoff level.

Here's a breakdown of what can be extracted and what information is missing:

Information from the document:

Device Name: Immunalysis Methamphetamine ELISA for Oral Fluids
Intended Use: 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. Intended for clinical laboratory use only.
Confirmatory Method: Gas chromatography/mass spectrometry (GC-MS) is the preferred confirmatory method.

Missing Information (not detailed in this clearance letter):

A table of acceptance criteria and the reported device performance: This letter does not contain the specific performance data, such as sensitivity, specificity, accuracy, or cross-reactivity, that would typically be presented in a study report. It only states the cutoff value.
Sample size used for the test set and the data provenance: The letter does not specify the number of samples used in the validation studies, nor the origin (country, retrospective/prospective) of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not discussed in the clearance letter. The ground truth method is mentioned (GC-MS), but not the number or qualifications of experts involved in data analysis or interpretation if applicable beyond the GC-MS results themselves.
Adjudication method: Not discussed.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is an in-vitro diagnostic (IVD) device, not an imaging or interpretation device that would involve human readers in that capacity. The device provides a direct result.
Standalone performance: The letter implies standalone performance as it's an ELISA kit, but it doesn't present the data.
Type of ground truth used: The letter explicitly states that "Gas chromatography/mass spectrometry (GS-MS) is the preferred confirmatory method," indicating that GC-MS results were used as the ground truth.
Sample size for the training set: Not mentioned. ELISA kits are typically developed and validated rather than "trained" in the machine learning sense, so a "training set" might not be applicable in the same way. However, initial assay development would involve optimizing parameters using a set of samples.
How the ground truth for the training set was established: Not mentioned, though it would likely also involve GC-MS or similar gold-standard methods applied to the development samples.

Summary of available information:

Ground Truth Method: GC-MS (Gas chromatography/mass spectrometry) is stated as the preferred confirmatory method, implying it was used as the ground truth for validating the ELISA test.
Cutoff Value: 50 ng/mL of d-methamphetamine for qualitative detection.

To answer your full request, you would need to consult the original 510(k) submission document or the manufacturer's performance data, which are not included in this FDA clearance letter.

Summary

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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:

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

Office of In Vitro Diagnostic Device Evaluation and Salety

510(k) K051577

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Regulation Number and Section

§ 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).