(129 days)
The Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Amphetamine 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.
Not Found
The document provided is a 510(k) clearance letter for the Immunalysis Amphetamine ELISA for Oral Fluids device. This type of document primarily confirms that a medical device is substantially equivalent to a legally marketed predicate device. It does not typically contain detailed acceptance criteria, study methodologies, or performance results in the way that a clinical study report or a more comprehensive premarket application might.
Based on the provided text, I can extract the following limited information:
1. Acceptance Criteria and Reported Device Performance:
The document mentions a cutoff of 50 ng/mL of d-Amphetamine for qualitative detection. It explicitly states: "The Immunalysis Amphetamine 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."
This implies that the "acceptance criteria" for the device's performance in this context is its ability to provide a preliminary screen for amphetamine at or above the 50 ng/mL cutoff, and acknowledged that confirmation by a more definitive method (GC-MS) is required for a conclusive result.
The document does not provide a table of specific analytical performance metrics (e.g., sensitivity, specificity, accuracy, precision) or a direct comparison to acceptance criteria values.
2. Sample Size and Data Provenance:
- Test set sample size: Not specified in the provided text.
- Data provenance: Not specified in the provided text.
3. Number and Qualifications of Experts for Ground Truth:
- Not applicable/Not specified. This is an analytical device, not an interpretation device that would involve expert readers for ground truth establishment.
4. Adjudication Method for Test Set:
- Not applicable/Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is an immunoassay for detecting amphetamine, not an imaging or diagnostic interpretation device that would involve human readers.
6. Standalone (Algorithm Only) Performance:
- Yes, the device is designed to operate in a standalone manner to provide a preliminary analytical result. The performance is the output of the ELISA assay. However, the exact performance metrics are not described in this document.
7. Type of Ground Truth Used:
- While not explicitly stated for the "study" itself in this document, the industry standard for confirming positive drug screens from such devices is Gas Chromatography/Mass Spectrometry (GC-MS), which the document also identifies as the "preferred confirmatory method." GC-MS is an objective, highly specific, and sensitive analytical method considered the gold standard for drug confirmation. Therefore, the ground truth for this type of device's performance evaluation would typically be established by comparing ELISA results to GC-MS results from the same samples.
8. Sample Size for Training Set:
- Not specified in the provided text.
9. How Ground Truth for Training Set Was Established:
- Not specified in the provided text. For an ELISA assay, the "training set" might refer to samples used during assay development and optimization, where ground truth would also be established by reference methods like GC-MS.
Summary of missing information from the provided document:
The provided 510(k) clearance letter focuses on regulatory approval and substantial equivalence. It does not include the detailed performance data, study design, sample sizes, or specifics of ground truth establishment that would typically be found in a full clinical or analytical study report. This kind of information would typically be part of the 510(k) submission itself, but is not extracted into the public-facing clearance letter.
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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 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 circle around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael J. Vincent V.P. Operations Immunalysis Corp. 829 Towne Center Drive Pomona, CA 91767
Re: K051579
Trade/Device Name: Immunalysis Amphetamine ELISA for Oral Fluids Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: August 10, 2005 Received: August 22, 2005
APR - 6 2006
Dear Mr. Vincent:
This letter corrects our substantially equivalent letter of October 21, 2005.
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).
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
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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,
Albert G. A.
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): K051579
Immunalysis Amphetamine ELISA for Oral Fluids Device Name:
Indications For Use:
The Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Amphetamine 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.
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)
Tracy Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
Page I of 1
510(k) K051579
§ 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).