← Product Code [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN) · K191635

# Optilite IgM Kit (K191635)

_The Binding Site Group , Ltd. · CFN · Jul 15, 2019 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191635

## Device Facts

- **Applicant:** The Binding Site Group , Ltd.
- **Product Code:** [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN.md)
- **Decision Date:** Jul 15, 2019
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

The Optilite IgM Kit is intended for the quantitative measurement of IgM in human serum and plasma by turbidimetry on the Optilite analyzer.

## Device Story

Optilite IgM Kit is an in vitro diagnostic reagent system for quantitative measurement of IgM in human serum, lithium heparin, or EDTA plasma. Device operates on Binding Site Optilite analyser using immunoturbidimetric principle; specific antiserum reacts with IgM antigen to form insoluble complexes. Light transmission through suspension is measured by photodiode; transmitted light is inversely proportional to IgM concentration. Instrument automatically calculates concentration via stored calibration curve. Used in clinical laboratories by trained personnel. Output provides quantitative IgM levels to assist clinicians in diagnosing abnormal protein metabolism and immune system deficiencies. Results are interpreted alongside other clinical and laboratory findings.

## Clinical Evidence

No clinical studies were performed. Evidence consists of analytical bench testing including precision (repeatability, within-lab, between-instrument, between-lot), linearity, and method comparison against the predicate. Method comparison (n=180 samples) showed a correlation coefficient of 0.999, a mean bias of -2.13%, and Passing-Bablok slope of 0.9775. Reference interval transfer was validated using 20 healthy donor samples. Stability was verified via accelerated and real-time studies per CLSI EP25-A.

## Technological Characteristics

Turbidimetric immunoassay; reagent contains goat anti-IgM antisera; designed for use on Optilite analyzer; quantitative measurement principle.

## Regulatory 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.

## Predicate Devices

- Optilite IgM Kit ([K082129](/device/K082129.md))

## Submission Summary (Full Text)

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Food and Drug Administration
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# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K191635

B Applicant
The Binding Site Group Ltd.

C Proprietary and Established Names
Optilite IgM Kit

D Regulatory Information
|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  CFN | Class II | 21 CFR 866.5510 - Immunoglobulins A, G, M, D, And E Immunological Test System | IM - Immunology  |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device is the Human IgM Kit for Use on SPAPlus and 510(k) K082129.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.

K191635 - Page 1 of 2

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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 for the IgM Kit Reagent antibody source material from the previously cleared sheep anti-IgM antisera to the new goat anti-IgM antisera.

4. Comparison Information (i.e., similarities and differences) to the submitter'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 submitter'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 submitter 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 device.

K191635 - Page 2 of 2

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191635](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191635)

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