Human IgM Kit for use on SPAPlus

K191465 · The Binding Site Group , Ltd. · CFN · Jun 27, 2019 · Immunology

Device Facts

• Record ID: K191465
• Device Name: Human IgM Kit for use on SPAPlus
• Applicant: The Binding Site Group , Ltd.
• Product Code: CFN · Immunology
• Decision Date: Jun 27, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Device Story

The Human IgM Kit for use on SPAPLUS is an in vitro diagnostic reagent system used to quantify human IgM levels in serum or plasma samples. The device utilizes immunoturbidimetry: patient samples are mixed with goat anti-human IgM antiserum, forming insoluble antigen-antibody complexes. The SPAPLUS analyzer passes light through the suspension; the amount of transmitted light, measured by a photodiode, is inversely proportional to the IgM concentration. The system automatically calculates concentrations using a stored calibration curve. It is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in evaluating protein metabolism and immune function. The device is a modification of a previously cleared kit (K082129), featuring a change in the source of the detection antibody (goat vs. sheep) and the antibody resting buffer composition. Performance is validated through precision, linearity, and method comparison studies against the predicate.

Clinical Evidence

No clinical studies were performed. Analytical performance was established via bench testing, including precision (repeatability, within-lab, between-instrument, and between-lot), linearity, and method comparison against the predicate. Method comparison (n=133) showed a correlation coefficient of 0.996 and a mean bias of -2.18%. Reference interval transfer was validated using 20 healthy donor samples.

Technological Characteristics

Turbidimetric immunoassay; utilizes goat anti-IgM antisera. Automated system for use on SPAPlus analyzer. Fundamental technology is unchanged from predicate device.

Indications for Use

Indicated for the quantitative determination of human IgM in serum for the assessment of immunoglobulin levels in patients.

Regulatory Classification

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

• Human IgM Kit for Use on SPAPlus (K082129)

Submission Summary (Full Text)

{0}

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K191465

B Applicant
The Binding Site Group Ltd.

C Proprietary and Established Names
Human IgM Kit for use on SPAPlus

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) 082129.
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.

K191465 - Page 1 of 2

{1}

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 SPAPlus IgM 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.

K191465 - Page 2 of 2