(66 days)
The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues. The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay. The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.
Not Found
This document is an FDA 510(k) clearance letter and an accompanying "Indications for Use Statement" for the K-ASSAY CRP (2) Assay and related calibrators. It explicitly states that the device is "substantially equivalent" to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, specific device performance data from a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training set used for the device.
The document grants market clearance based on a determination of substantial equivalence to existing devices, meaning it doesn't require the detailed performance data and study descriptions typically found in a new device's clinical validation report.
Therefore, I cannot provide the requested table and study details based on the input text. The text focuses solely on regulatory approval and states the intended use of the device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
SEP 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K992312
Trade Name: K-ASSAY CRP (2), K-ASSAY CRP Multi-Calibrator A, K-ASSAY CRP Multi-Calibrator C
Regulatory Class: II Product Code: DCK Dated: July 7, 1999 Received: July 9, 1999
Dear Mr. Getty:
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.
{1}------------------------------------------------
Page 2
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 Dutman
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}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K992312
K-ASSAY CRP (2) Device Name:
Indications For Use:
CRP (2) 510(k)
The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues.
The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.
The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K992312 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
Optional Format 1-2-96)ಟ
6/21/99
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).