K191985 · The Binding Site Group , Ltd. · CFN · Aug 19, 2019 · Immunology
Device Facts
Record ID
K191985
Device Name
Optilite IgA Kit
Applicant
The Binding Site Group , Ltd.
Product Code
CFN · Immunology
Decision Date
Aug 19, 2019
Decision
SESE
Submission Type
Special
Regulation
21 CFR 866.5510
Device Class
Class 2
Indications for Use
The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.
Device Story
The Optilite IgA Kit is an in vitro diagnostic reagent system used on the Binding Site Optilite analyser. It utilizes immunoturbidimetry to measure IgA concentration in patient serum or plasma samples. The device employs goat anti-IgA antibodies that react with IgA in the sample to form insoluble complexes. When light passes through this suspension, the transmitted light is measured by a photodiode; the intensity of transmitted light is inversely proportional to the IgA concentration. The analyser automatically calculates concentrations using a stored calibration curve. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing abnormal protein metabolism and immune system deficiencies. The modification in this submission involves changing the detection antibody source from sheep to goat, with performance verified through precision, linearity, and method comparison studies against the predicate.
Clinical Evidence
No clinical studies were performed. Evidence consists of analytical bench testing, including precision (repeatability, within-lab, between-instrument, and between-lot), linearity, and method comparison against the predicate using 102 serum and 42 plasma samples. Method comparison showed a correlation coefficient of 0.998 and a mean bias of 2.38%. Reference interval transfer was verified using 20 healthy donor samples.
Technological Characteristics
Immunoturbidimetric assay; utilizes goat anti-IgA antisera; designed for use on the Optilite analyzer; quantitative measurement of human IgA in serum/plasma.
Indications for Use
Indicated for the quantitative determination of human IgA in serum and plasma to aid in the diagnosis and treatment of IgA deficiency, myeloma, and other immunoglobulin-related diseases.
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.
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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
K191985
B Applicant
The Binding Site Group Ltd.
C Proprietary and Established Names
Optilite IgA Kit
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CFN, JIT, JJX | 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 IgA 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 and package labeling.
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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 the 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.
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