← Product Code [DFH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFH) · K181438

# Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438)

_Diazyme Laboratories, Inc. · DFH · Jun 26, 2018 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFH/K181438

## Device Facts

- **Applicant:** Diazyme Laboratories, Inc.
- **Product Code:** [DFH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFH.md)
- **Decision Date:** Jun 26, 2018
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5550
- **Device Class:** Class 2
- **Review Panel:** Immunology

## 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 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 Story

The Diazyme Human Kappa and Lambda Free Light Chain Assays are in-vitro diagnostic reagents used for the quantitative measurement of free light chains in human serum. The device utilizes a latex particle-enhanced immunoturbidimetric assay principle. Samples are processed on Hitachi 917 clinical chemistry analyzers. The assay measures the turbidity resulting from the antigen-antibody reaction between the FLC in the patient serum and specific antibodies coated on latex particles. The resulting concentration values are used by clinicians in conjunction with other laboratory findings to aid in the diagnosis of multiple myeloma. The device is intended for professional use in clinical laboratory settings.

## Clinical Evidence

No clinical data provided; modification is limited to labeling (reference range update). Substantial equivalence supported by design control activities and risk analysis.

## Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents consist of latex particles coated with specific antibodies for Kappa or Lambda light chains. Designed for use on Hitachi 917 clinical chemistry analyzers. Quantitative measurement based on light absorbance/turbidity changes.

## Regulatory 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.

## Predicate Devices

- The Binding Site Human Kappa and Lambda Free Light Chain Assays ([K062948](/device/K062948.md))

## Submission Summary (Full Text)

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# SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: K181438

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device.
K153394;
Diazyme Human Kappa (κ) Free Light Chain Assay
Diazyme Human Lambda (λ) Free Light Chain Assay
Diazyme Human Kappa/Lambda FLC Calibrator Set
Diazyme Human Kappa/Lambda FLC Control Set

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to modify the Reference Range section in the package insert by adding the normal range of the Kappa to Lambda FLC ratio.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFH/K181438](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFH/K181438)

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