(22 days)
Not Found
Not Found
No
The summary describes a test sample for monitoring assay performance, not a device that processes data or images using AI/ML.
No
The device is described as a "consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays," indicating it is a quality control material for an assay rather than a device for treating a condition.
No
Explanation: The device is described as a "consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays." This indicates it is a quality control material used to assess the performance of diagnostic assays, rather than a diagnostic device itself that directly diagnoses a condition.
No
The provided 510(k) summary describes a "consistent test sample of known concentration" for monitoring the performance of an assay. This description strongly suggests a physical or chemical substance used for calibration or quality control, not a software application. The lack of any mention of software, algorithms, data processing, or digital interfaces further supports this conclusion.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays." D-Dimer assays are used to measure D-dimer levels in blood, which is a diagnostic test performed in vitro (outside the body) to help diagnose conditions like deep vein thrombosis or pulmonary embolism.
- Monitoring Performance of Assays: The device is designed to ensure the accuracy and reliability of these diagnostic assays. This is a key function of quality control materials used in IVD testing.
While the "Device Description" is not found, the intended use strongly points towards it being a product used in the process of performing in vitro diagnostic tests. It acts as a control or calibrator for those tests.
N/A
Intended Use / Indications for Use
As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.
Product codes
GGC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
2
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)