(113 days)
The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.
For in vitro diagnostic use.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "K-Assay® Total IgE Assay" and "K-Assay® IgE Calibrator." This document primarily communicates the FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
It does NOT contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information on expert ground truth establishment (number, qualifications, adjudication method).
- Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
This type of information would typically be found in the device's original 510(k) submission, specifically in the performance study sections, which are not included in this FDA decision letter. The letter confirms clearance but does not provide the underlying study data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 0 2004
Kamiya Biomedical Co. c/o Mr. Brian Schliesman 12779 Gateway Dr. Seattle, WA 98168
Re: K042241
Trade/Device Name: K-Assay® Total IgE Assay K-Assay® IgE Calibrator Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: DGC, JIT Dated: August 17, 2004 Received: September 7, 2004
Dear Mr. Schliesman:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 -- Mr. Brian Schliesman
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K04224 / /
K-ASSAY® Total IgE Assay and Device Name: K-ASSAY® IgE Calibrator Set
Indications For Use:
The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.
For in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
' eba
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K04224/
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Optional Format 1-2-96)
IgE 510 (k), KAI-092 KAMIYA BIOMEDICAL COMPANY 11/2004
4
Rev.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).