(147 days)
For in vitro diagnostic point-of-care prescription use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use singledrug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay 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. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "IMPACT Test System; Saliva Test Module- Opiate." It grants market clearance based on substantial equivalence to a predicate device. However, it does not include the detailed study or performance data that would typically contain acceptance criteria, sample sizes, ground truth establishment, or expert information as requested in your prompt.
Specifically, the document focuses on:
- Confirming the device name and regulation details.
- Stating that the device is substantially equivalent to a legally marketed predicate device.
- Outlining regulatory requirements and responsibilities for the manufacturer.
- Providing an "Indications For Use Statement" which describes what the device is intended for (in-vitro diagnostic, rapid determination of Opiate in human saliva at a cut-off of 40 ng/mL, professional/prescription use). It also mentions that the assay provides only a preliminary result and requires confirmation by more specific methods like GC/MS for a confirmed analytical result.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the text provided. This information would typically be found in the 510(k) submission document itself, which is a much more extensive technical dossier than the FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
NOV 2 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David B. Goldberg, Ph.D. Director, Regulatory Affairs and Quality Systems LifePoint, Inc. 1205 South Dupont Street Ontario, CA 91761
K041746 Re:
Ro41710
Trade/Device Name: IMPACT Test System; Saliva Test Module- Opiate Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, KHO Dated: October 13, 2004 Received: October 14, 2004
Dear Dr. Goldberg:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA 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 STATEMENT
510(K) Number (if known): K
Device Name: IMPACT Test System; Saliva Test Module - Opiate
Indications For Use: For in vitro diagnostic point-of-care prescription use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use singledrug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay 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. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
× Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
OTC Use of the state and
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto S
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostla Device Evaluation and Safety
510(k) K041796
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).