(66 days)
The K-ASSAY CRP (I) Assay is intended to be used for the quantitative determination of C-Reactive Protein (CRP) in serum by a latex enhanced immunoturbidimetric method. Measurement of CRP is useful as an aid in the detection and evaluation of inflammatory conditions and tissue injury. CRP is an acute phase reactant protein that is elevated in the presence of inflammatory processes, infection, and tissue injury. Measurement of CRP is useful as an aid in the detection and evaluation of inflammatory conditions and tissue injury.
The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (I) Assay.
The K-ASSAY CRP Multi-Calibrator C is intended to be used for the calibration of the K-ASSAY CRP (I) Assay.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the K-ASSAY CRP (I), K-ASSAY CRP Multi-Calibrator A, and K-ASSAY CRP Multi-Calibrator C. It states that the devices are substantially equivalent to legally marketed predicate devices. The "Indications for Use Statement" describes the intended use of the K-ASSAY CRP (I) Assay for quantitative determination of C-Reactive Protein (CRP) in human serum, with the calibrators intended for calibration of the assay.
However, the document does not contain the detailed acceptance criteria and study information requested in the prompt. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The 510(k) letter confirms clearance based on substantial equivalence to a predicate device, which usually implies that the new device performs similarly to an already approved device. The specifics of the performance studies that supported this equivalence are typically found within the full 510(k) submission, not in the final clearance letter itself.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is slightly tilted.
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: K992311
Trade Name: K-ASSAY CRP (1), 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.
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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 vours.
Steven Putman
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K992311/A²/1
K-ASSAY CRP (I) Device Name:
Indications For Use:
The K-ASSAY CRP (I) Assay is intended to be used for the quantitative determination of The N-ASSAT ONL (1) 7 (1) 1.66ay to intel enhanced immunoturbidimetric C-Reactive i forem (ORT) in obrain by faten participant 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 (I) Assay.
The K-ASSAY CRP Multi-Calibrator C is intended to be used for the calibration of the K-ASSAY CRP (I) Assay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devise Evaluation (ODE)
Peter Malone
(Division Sign-Off)
Division of Clinical Laboratory Devices K992311
510(k) Number
Division of Clinical Laboratory Devices
510(k) Number K99
OR
Over-The-Counter Use _
Optional Format 1-2-96)
Prescription Use / (Per 21 CFR 801.109)
§ 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).