(23 days)
The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and related diseases. FOR IN VITRO DIAGNOSTIC USE.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "K-ASSAY Apo B." This document primarily grants substantial equivalence and does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such detailed information is typically found in the 510(k) summary, which is a separate document.
Therefore, I cannot extract the requested information from the provided text for the following reasons:
- No Acceptance Criteria: The document does not specify any performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
- No Reported Device Performance: While the device is cleared for "quantitative determination of Apo B," the document does not contain numerical performance data such as assay precision, accuracy, linearity, or comparison with a reference method.
- No Study Details: There is no mention of the type of study conducted (e.g., prospective, retrospective), sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
- No Ground Truth Information: The document does not describe how ground truth was established for development or testing sets.
The core of this document is the FDA's regulatory decision, not a scientific report of a device's performance characteristics.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 1999
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K993354 Re: Trade Name: K-ASSAY Apo B Regulatory Class: II Product Code: DER Dated: October 4, 1999 Received: October 5, 1999
Dear Mr. Getty:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(k) indiness of the maint (for the indications for use above and we have determined the uevice is subsitions marketed in interstate commerce
s the enclosure) to legally marketed prodical all a line increasedments, or to devices t stated in the enclosure) to legally marketed produced onemanents, or to devices that
prior to May 28, 1976, the enactment date of the Medical Food. Drug, and proof to May 28, 1976, the enatinent use of the Federal Food, Drug, and have been reclassified in accordance with the provice, subject to the general controls Cosmetic Act (Act). You may, increiore, inance include requirements for annual provisions of the Act. The general controls provisions of the Pers.
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 If your device is classified (see advect to such additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions, Title 21, Parts 8 (Premarket Approval), it may be subject to such additions, Title 21, Paris 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Paris affecting your device can oc tould in the essumes compliance with the Current Good
A substantially equivalent determination assumes of the Sustem Requalation ( A substantially equivalent determination as set forth in the Quality System Regulation (QS) for
Manufacturing Practice requirements, as set for a set they the provise period Manufacturing Practice requirements, as so form and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, the assumptions Medical Devices: General regulation (2) - 21 x 1 a assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assisten inspections, the Food and Drug Administration in 1977) will and titlem, FDA may publish
comply with the GMP regulation may result in regulation, Plansa pote: this comply with the GMF regulation may result in the Federal Register. Please note: this further announcements concerning your device in thees not affect any obligation you might
response to your premarket notification submission does and earn Electronic Product response to your premarket nothleation submission does not have and the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
Sincercly yours,
Steven Putman
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): K993354
Device Name: K-ASSAY Apo B.
Indications for Use:
The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of The R-ROOAT 7 tpo D Noody is intonurbidimetric assay. Apolipoprotein measurements
Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements Are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus),
are used in the diagnosis and treatment of lipid disorders (Such VITRO DIACNIOSTIC are used in the diagnosis and realing of the sall disorders. FOR IN VITRO DIAGNOSTIC USE.
Pan
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K 993354
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Optional Format 1-2-96)
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).