(358 days)
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No
The summary describes a standard immunoturbidimetric assay for measuring cystatin C, a common laboratory test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found in the provided text) point towards a traditional in vitro diagnostic assay.
No
The device is for in vitro diagnostic use, meaning it's used to measure substances in samples taken from the human body, specifically cystatin C, to aid in diagnosis and treatment monitoring, not to directly treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE." This indicates its role in diagnosis.
No
The device is an in vitro diagnostic assay, which involves reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "FOR IN VITRO DIAGNOSTIC USE" for both the K-ASSAY® Cystatin C Assay and the K-ASSAY® Cystatin C Calibrator.
- The intended use is for the quantitative determination of human cystatin C in biological samples (serum, plasma) and the measurements are used as an aid in the diagnosis and treatment of renal diseases. This is a typical application for an IVD.
N/A
Intended Use / Indications for Use
The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.
Product codes
NDY, JIT, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Kamiya Biomedical Company c/o Shawn Kaplan Clinical Diagnostics Product Manager 12779 Gateway Drive, Seattle, WA 98168, USA
K093137 Re: Trade/Device Name:
K-ASSAY Cystatin C Assay K-ASSAY Cystatin C Calibrator K-ASSAY Cystatin C Control
Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY, JIT, JJX Dated: September 21, 2010 Received: September 23, 2010
SEP 2 8 2010
Dear Mr. Kaplan
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
.
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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KAMIYA BIOMEDICAL COMPANY
12779 Gateway Drive, Seattle, WA 98168 USA
Tel: 206.575.8068 Fax: 206.575.8094
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ________ K093137
SEP 2 8 2010
Cystatin C Assay Device Name:
Indications For Use:
The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 5093137
KAMIYA BIOMEDICAL COMPANY
K-ASSAY® Cystatin C Assay 510(k) Page 4
2009-09-28