(134 days)
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary (Re: K023131) does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a clearance letter from the FDA, stating that "FREELITE Human Lambda Free Kit for Use on the Hitachi 911/912 Analyzer" is substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not detail the performance metrics, study design, or results that would demonstrate the device's accuracy or efficacy.
Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, or training set details based on the information given. This type of information would typically be found in the 510(k) submission itself or a more detailed performance study report.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 1 2003
The Binding Site, Limited c/o Mr. Jay H. Geller 2425 West Olympic Boulevard West Tower, Suite 4000 Santa Monica, California 90404
Re: K023131
Trade/Device Name: FREELITE Human Lambda Free Kit for Use on the Hitachi 911/912 Analyzer Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunoglobulin Test System Regulatory Class: II Product Code: DEH Dated: January 3, 2003 Received: January 8, 2003
Dear Mr. Geller:
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.
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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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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023131 INDICATIONS FOR USE STATEMENT
Device Name: FREELITE Human Lambda Free Kit for Use on the Hitachi 911/912 Analyzer
Indications for Use: This kit is intended for the quantitation of lambda free light chains in serum and urine on the Roche Hitachi Measurement of the various amounts of the 911 and Hitachi 912. different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.
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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)
A. Reeves for J. Bautista
Division of Clinical Laboratory 510(k) Number
Cheumatoid Factor 5100k
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).