Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay by Diazyme Laboratories Inc.

The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.

Device Description

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AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay. It states the intent to market the device and declares it substantially equivalent to legally marketed predicate devices.

While it mentions the intended use of the assays (quantitative determination of Kappa/Lambda FLC in serum to aid in the diagnosis of multiple myeloma), it does not provide details on:

Specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity thresholds).
A study design, methodology, or results demonstrating device performance against such criteria.
Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical study details.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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June 26, 2018

Diazyme Laboratories Inc. Abhijit Datta VP of Technical Operations 12889 Gregg Court Poway, California 92130

Re: K181438

Trade/Device Name: Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: May 30, 2018 Received: June 1, 2018

Dear Abhijit Datta:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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For

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181438

Device Name

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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).