(20 days)
Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.
Reference Material for Delta-9-THC-COOH in Human Urine
The provided text is a 510(k) clearance letter from the FDA for a Reference Material for Delta-9-THC-COOH in Human Urine. This type of device is a calibration or control material used to verify the accuracy of laboratory tests (specifically GC/MS methods) for detecting a marijuana metabolite.
The information you are asking for, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment, is not typically found in a 510(k) clearance letter.
A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This equivalence is based on the data and information provided by the manufacturer in their 510(k) submission, which would contain the study details. However, the clearance letter itself only summarizes the FDA's decision, not the full details of the supporting studies.
Therefore, I cannot provide the requested information from the given document.
To answer your questions, I would need access to the actual 510(k) submission which would include the performance data and study reports.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 14 1999
Ms. E. Kay Robinson Manager, Proficiency Products Consolidated Technologies 2170 Woodward Street Suite 100 Austin, Texas 78744-1832
K992151 Re:
Trade Name: Reference Material for Delta-9-THC-COOH in Human Urine Regulatory Class: I reserved Product Code: LAS Dated: June 23, 1999 Received: June 24, 1999
Dear Ms. Robinson:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Register. 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if 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 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,
Steven Toutman
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
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Indication for Use
Device Name: Reference Material for Delta-9-THC-COOH in Human Urine
Indication for Use: Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number _ K 99 21 51
(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)
§ 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.