(66 days)
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Not Found
No
The summary describes a standard immunoturbidimetric assay for measuring Lp(a) in serum, which is a chemical/biological test method and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is described as an "in vitro diagnostic reagent," which is used for quantitative determination of a substance in human serum to assess risk, not for directly treating a condition.
Yes
This device is described as "an in vitro diagnostic reagent," which indicates its intended use is for diagnosing diseases or conditions. The text explicitly states it is for the "quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay" and "may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease." These functions fall under the definition of a diagnostic device.
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent..."
- "The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent..."
- "For in vitro diagnostic use."
These statements clearly indicate that the device is intended for use in testing biological samples outside of the body to diagnose or provide information about a medical condition.
N/A
Intended Use / Indications for Use
The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay.
For in vitro diagnostic use.
Product codes
DFC; JIS
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 5 2002
Mr. Brian Schliesman Official Correspondent Kamiva Biomedical Company 910 Industry Drive Seattle, WA 98188
Re: K021660
Trade/Device Name: K-Assay® Lipoprotein (a) Immunoturbidimetric Assay and K-Assay® Lipoprotein (a) Calibrator Regulation Number: 21 CFR 866.5600 Regulation Name: Low density Lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC; JIS Dated: May 13, 2002 Received: May 20, 2002
Dear Mr. Schliesman:
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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - .
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 i 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 Manufacturers 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/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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): K02-0166
K-ASSAY® Lipoprotein (a) Immunoturbidimetric Assay and Device Name: K-ASSAY® Lipoprotein (a) Calibrator
Indications For Use:
The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay.
For in vitro diagnostic use.
Jean Cooper
(Division of
Division of
510(k) Number X021660
(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)