(345 days)
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No
The summary describes an in vitro diagnostic reagent and calibrator for a quantitative immunoturbidimetric assay, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic reagent and calibrator used for the quantitative determination of albumin in a urine sample, aiding in the diagnosis of kidney dysfunction. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurement of albumin in urine aids in the diagnosis of kidney dysfunction" and "FOR IN VITRO DIAGNOSTIC USE."
No
The 510(k) summary describes a reagent and calibrator for an in vitro diagnostic assay, which are physical components, not software.
Yes, the provided text explicitly states that the K-ASSAY® Microalbumin reagent and calibrator are FOR IN VITRO DIAGNOSTIC USE.
This phrase is the key indicator that these devices are intended to be used outside of the body (in vitro) to diagnose a condition (kidney dysfunction) based on the analysis of a biological sample (urine).
N/A
Intended Use / Indications for Use
The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.
The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
Product codes
DCF, JIT
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)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Kamiya Biomedical Co. c/o Mr. Shawn Kaplan Clinical Diagnostics Product Manager 12779 Gateway Drive Seattle, WA 98168
APR 29 2010
Re: K091486
Trade Name: K-Assay® Microalbumin, K-Assay® Microalbumin Calibrator Regulation Number: 21 CFR $866,5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Codes: DCF, JIT Dated: April 14, 2010 Received: April 20, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 yours,
Signature
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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INDICATIONS FOR USE FORM
510(k) Number (if known): K091486
Device Name: Microalbumin Assay
Indications For Use:
The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.
K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
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)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091486
KAMIYA BIOMEDICAL COMPANY
K-ASSAY® Microalbumin Assay 510(k) Page 4
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