(6 days)
None
There are no K/DEN numbers listed in the provided text.
No
The document describes a control solution for drug testing and contains no mention of AI or ML technology.
No
The device is described as a control for monitoring assay performance of patient urine specimens when assaying for opiates, indicating a diagnostic rather than therapeutic purpose.
No
The device is described as "controls" for monitoring assay performance, not for diagnosing patient conditions directly.
No
The device description is not found, but the intended use describes "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3" which are likely physical control materials used in a laboratory setting, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring assay performance of patient urine specimens" when assaying for opiates. This involves testing biological samples (urine) outside of the body to provide information about a patient's health status (in this case, the presence of opiates).
- Device Type: The description refers to "Liquid Opiates Drugs of Abuse Control Levels G2 and G3". Controls used in laboratory assays to ensure the accuracy and reliability of the test are a common type of IVD.
While the "Device Description" is not found, the intended use strongly points towards an IVD. The fact that it's a control used in conjunction with patient urine specimens for drug testing aligns perfectly with the definition of an IVD.
N/A
Intended Use / Indications for Use
Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3 are intended for use as a consistant tool sample of patient urine specimens for monitoring assay of known concentration. Include the controls with patient urine specimens when assaying for opiates.
Product codes
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.
0
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 4 1998
Mary Thorsness . Senior Specialist, Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
K983127 Re : Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels 1 and 2 Requlatory Class: I Product Code: DIF Dated: September 4, 1998 September 8, 1998 Received:
Dear Ms. Thorsness:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. The association of it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance its internet address "https://www.iramaraccurers A85185ance its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page / of /
510(k) Notification ● Sept 4, 1998 Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3
Statement of Indications for Use
Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3 are Oprates 2000 Ochiro Engand Optates Drage of known concentration for monitoring assay intended for use as a consident toot samply of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division Sign Over
(Division Sign-Off) Division of Clinical Laborato 510(k) Number _