← Product Code [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN) · K192116

# Human IgA liquid reagent kit for Use on SPAPlus (K192116)

_The Binding Site Group , Ltd. · CFN · Sep 4, 2019 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K192116

## Device Facts

- **Applicant:** The Binding Site Group , Ltd.
- **Product Code:** [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN.md)
- **Decision Date:** Sep 4, 2019
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA 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 device is an in vitro diagnostic reagent kit used on the Binding Site SPAPLUS turbidimetric analyzer. It utilizes monospecific goat anti-IgA antibodies to react with IgA in patient serum or plasma samples, forming insoluble complexes. The analyzer passes light through the suspension; the amount of transmitted light is measured by a photodiode and is inversely proportional to the IgA concentration. The system automatically calculates concentrations using a stored calibration curve. It is operated by laboratory technicians in clinical settings. The output provides quantitative IgA levels, which clinicians use alongside other findings to assess protein metabolism and immune function, aiding in the diagnosis of related disorders.

## Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing demonstrating performance consistency following the change in antibody source material.

## Technological Characteristics

Immunoturbidimetric assay; liquid reagent format; utilizes goat anti-IgA antisera; designed for use on SPAPLUS automated analyzer; fundamental technology unchanged from predicate.

## 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

- Human IgA liquid reagent kit for use on SPAPlus ([K103824](/device/K103824.md))

## Submission Summary (Full Text)

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Food and Drug Administration
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www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K192116

B Applicant
The Binding Site Group Ltd

C Proprietary and Established Names
Human IgA liquid reagent 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 Human IgA liquid reagent kit for use on SPAPlus and 510(k) K103824
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, package labeling.

K192116 - 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 IgA Reagent antibody source material from a previously cleared sheep anti-IgA antisera to the new goat anti-IgA 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.

K192116 - Page 2 of 2

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K192116](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K192116)

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