(22 days)
As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.
Not Found
This is an FDA K-number document. The information provided does not include the details to fill out the table of acceptance criteria and the study that proves the device meets the acceptance criteria. This document primarily focuses on the FDA's decision regarding the substantial equivalence of the K-ASSAY D-Dimer Controls to a legally marketed predicate device, allowing it to proceed to market.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: This document states the device is being cleared for marketing based on substantial equivalence. It does not contain details about specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or the acceptance criteria established for those metrics. These would typically be found in the actual 510(k) submission, which is not fully provided here.
- Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, Standalone, Ground Truth type, Training set info): The document summarizes the regulatory decision. It doesn't present the detailed study design, results, or methodologies (like sample sizes, experts, adjudication, or training data) that would be part of the technical data submitted by the manufacturer to the FDA. The "K012422" is the submission number, not a report of the study details itself.
In summary, this document is a regulatory approval letter, not a scientific study report describing the performance evaluation of the device.
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AUG 2 1 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Don Tran Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K012422 Trade Name: K-ASSAY D-Dimer Controls Regulation Number: 21 CFR § 864.5425 Regulatory Class: II Product Code: GGC Dated: July 20, 2001 Received: July 30, 2001
Dear Mr. Tran:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have and we have determined the device is substantially equivalent (for the indications for use above and we nave active actived 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 Cosmono rice (110). - The general controls provisions of the Act include requirements for annual provisions of the reason and acturing 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 ( Femanson up vice 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 mspotions, 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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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 noalicate 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionifacturers International and Consumer 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 Autman
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): ____________________________________________________________________________________________________________________________________________________
K-ASSAY D-Dimer Controls Device Name:
Indications For Use:
As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.
Josephine Bautista
y Devices
510(k) Number K014422
(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)
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.