(133 days)
Orasure Methamphetamine Intercept® Micro-Plate EIA
Orasure Methamphetamine Intercept® Micro-Plate EIA
No
The description details a standard enzyme immunoassay (EIA) for drug detection, which is a chemical-based test and does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is a qualitative detection test for methamphetamine in oral fluid, providing only preliminary results for diagnostic purposes, not for treatment or therapy.
Yes
The device is intended for the qualitative detection of Methamphetamine in oral fluid, providing a preliminary result that requires clinical consideration and professional judgment. This indicates its use in aiding in the diagnosis or detection of a substance.
No
The device description clearly indicates it is a "solid phase competitive enzyme immunoassay," which is a laboratory test method involving physical reagents and a micro-plate, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative detection of Methamphetamine in oral fluid." This involves testing a biological sample (oral fluid) in vitro (outside the body) to provide information about a person's health status (presence of methamphetamine).
- Device Description: It describes a "solid phase competitive enzyme immunoassay," which is a common laboratory technique used for in vitro testing.
- Calibrators and Controls: The description of calibrators and controls further supports its use in a laboratory setting for in vitro diagnostic testing to ensure accuracy and quality.
- Performance Studies: The mention of performance studies comparing it to a predicate device (another IVD) indicates it's undergoing the regulatory process for IVDs.
- Predicate Device: The predicate device listed is also an "Intercept® Micro-Plate EIA," which is a type of in vitro diagnostic test.
The fact that it's a "screen test" and requires confirmation by another method (GC/MS) is typical for many IVD drug screening tests. The key is that it's performing a diagnostic test on a biological sample in vitro.
N/A
Intended Use / Indications for Use
The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.
The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
Product codes
LAF
Device Description
Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA.
Results obtained from patient specimens showed that the results from the new assay are substantially equivalent to those obtained from the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Orasure Methamphetamine Intercept® Micro-Plate EIA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary----------------------------------------------------------------------------------------------------------------------------------------------------------------
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Apr. 9th, 2008 Date of Summary:
Correspondent:
| Name: | |
|---|---|
| Address: | |
| Phone Number: | |
| Fax Number: | |
Liuming Yu 10101 Renner Boulevard, Lenexa, Kansas 66210-9752 913-895-2308 913-577-1429 liuming.yu@labone.com
Product Name:
Common Name: Quest Diagnostics Methamphetamine Micro-Plate ElA Trade Name: Quest Diagnostics Methamphetamine Micro-Plate EIA Classification Number: 862.3610
Predicate Device:
Orasure Methamphetamine Intercept® Micro-Plate EIA
Product Description:
Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.
Intended Use:
Quest Diagnostics Methamphetamine Micro-Plate EIA is a competitive micro-immunoassay for the qualitative detection of Methamphetamines in oral fluid collected with the Orasure™ Oral Specimen Collection Device.
Comparison:
When used to qualitatively detect Methamphetamine in oral fluid specimens collected with the Orasure™ Oral Specimen Collection Device, the Quest Diagnostics Methamphetamine Micro-Plate EIA vields results in substantial agreement with the predicate device.
Comparison Performance Data:
Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA.
Results obtained from patient specimens showed that the results from the new assay are substantially equivalent to those obtained from the predicate device.
Conclusion:
The Quest Diagnostics Methamphetamine Micro-Plate EIA is substantially equivalent to the Orasure Methamphetamine Intercept® Micro-Plate EIA and can be used to qualitatively screen oral specimens collected with the Orasure™ Oral Specimen Collection Device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Quest Diagnostics, Inc. c/o Liuming Yu Associate Director 10101 Renner Blvd. Lenexa, K.S 66219-9752
JUN 2 5 2008
Re: K080381/S001 Trade Name: Quest Diagnostics Methamphetamine Micro-Plate EIA Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Micro-Plate EIA Regulatory Class: Class II Product Codes: LAF Dated: June 13, 2008 Received: June 17, 2008
Dear Liuming Yu:
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. 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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Indication for Use Statement
510(k) Number (if known) K 080381
Device Name: Quest Diagnostics Methamphetamine Micro-Plate EIA
Indications for Use
The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.
The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
Prescription Use X (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)
Carol C. Benson
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Office of In Vitro Diagnostic Device Frauation and Safety