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

K211648 · Diazyme Laboratories, Inc. · DFH · Sep 8, 2022 · Immunology

Device Facts

• Record ID: K211648
• Device Name: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
• Applicant: Diazyme Laboratories, Inc.
• Product Code: DFH · Immunology
• Decision Date: Sep 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

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 validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical 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 validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

Device Story

The Diazyme Human Kappa and Lambda FLC Assays are in-vitro diagnostic reagents used on validated clinical chemistry analyzers (e.g., Roche cobas c 501). The device utilizes latex particle-enhanced immunoturbidimetry; patient serum samples are mixed with latex particles coated with polyclonal rabbit/goat anti-human FLC antibodies. FLC in the sample binds to the antibodies, causing agglutination; the resulting turbidity is measured optically. The instrument calculates FLC concentration by interpolating the signal against a 6-point calibration curve. Results are used by clinicians alongside other laboratory and clinical findings to diagnose and monitor multiple myeloma. The assay is for prescription use only. This submission specifically revises the Limit of Quantification (LoQ) claims for the assays.

Clinical Evidence

Bench testing only. Linearity was validated across the analytical measuring interval (AMI) using dilution panels on the Roche cobas c 501 and other analyzers (Abbott Architect c8000, Beckman AU680, Diazyme c270). Detection capability (LoB, LoD, LoQ) was established per CLSI EP17-A2 using immune-depleted serum samples and verified across multiple instrument platforms. No clinical prospective or retrospective studies were required for this modification.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents consist of Tris buffer (R1) and latex microparticles coated with polyclonal rabbit/goat anti-human FLC antibodies (R2). Quantitative measurement via optical turbidity. Validated for use on automated clinical chemistry analyzers (e.g., Roche cobas c 501).

Indications for Use

Indicated for the quantitative determination of Kappa and Lambda Free Light Chain (FLC) concentrations in serum to aid in the diagnosis and monitoring of multiple myeloma in patients. For in-vitro diagnostic use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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September 8, 2022

Diazyme Laboratories Inc. Abhijit Datta VP of Technical Operations 12889 Gregg Court Poway, California 92064

Re: K211648

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: June 16, 2022 Received: June 21, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211648

Device Name

Diazyme Human Kappa Free Light Chain Assay

Indications for Use (Describe)

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 validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## Indications for Use

510(k) Number (if known) K211648

Device Name

Diazyme Human Lambda Free Light Chain Assay

Indications for Use (Describe)

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 validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."