(62 days)
A creatinine test system is an in vitro device intended to measure creatinine quantitatively in * serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.
Dual Vial Creatinine Reagent
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Dual Vial Creatinine Reagent." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. However, this document does not contain the specific information requested about acceptance criteria or the study that proves the device meets those criteria.
The clearance letter primarily focuses on:
- Device identification: Dual Vial Creatinine Reagent, K983937, Class II, Product Code: CGX.
- Regulatory status: Substantial equivalence determination.
- General compliance requirements: Annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration.
- Contact information for further regulatory questions.
- Indications for Use: "A creatinine test system is an in vitro device intended to measure creatinine quantitatively in serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions."
Therefore, I cannot fulfill your request for details regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, ground truth methods, or MRMC studies based solely on the provided text. These details would typically be found in the 510(k) submission itself (the "notification of intent to market") or a summary of its contents, which is not included here.
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6 1999 JAN
Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. 1152 3rd Avenue, Suite D/E P.O. Box 2219 Lonqview, Washington 98632
Re: K983937 Dual Vial Creatinine Reagent Trade Name: Requlatory Class: II Product Code: CGX Dated: October 29, 1998 November 5, 1998 Received:
Dear Dr. Legaz:
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 Requlations, 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 requlations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 leqally 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 requlation (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, "Misbrandinq 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indication for Use
Trade Name of the Device: Dual Vial Creatinine Reagent
510(k) Number: K983937
Classification Name; Number: Creatinine Test System; 21 CFR §862.1345
Indications for Use
- A creatinine test system is an in vitro device intended to measure creatinine quantitatively in * serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.
Sean Cooper 1/4/99
(Division Sign-Off)
Division of Clinical boratory Devices 510(k) Number
Prescription Use ✓
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.