← Product Code [DGC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC) · K214068

# Quantia IgE (K214068)

_Biokit, S.A. · DGC · Feb 21, 2023 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K214068

## Device Facts

- **Applicant:** Biokit, S.A.
- **Product Code:** [DGC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC.md)
- **Decision Date:** Feb 21, 2023
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology
- **Attributes:** Pediatric

## Indications for Use

The Quantia IgE is an in vitro diagnostic test for the quantitative determination of human immunoglobulin E (IgE) in serum or plasma by turbidimetric immunoassay on clinical chemistry analyzers.

## Device Story

Quantia IgE is an automated latex-enhanced immunoturbidimetric assay for total IgE measurement in human serum or plasma. The device uses polystyrene latex particles coated with mouse anti-human IgE. When mixed with patient samples and reaction buffer, IgE-mediated agglutination occurs; the degree of agglutination is directly proportional to IgE concentration. The device operates on ARCHITECT c Systems in clinical laboratory settings, performed by laboratory technicians. The system measures the decrease in transmitted light caused by aggregates. Healthcare providers use the quantitative output in conjunction with other clinical studies to diagnose IgE-mediated allergies. The device benefits patients by providing an automated, standardized method for IgE quantification to support allergy diagnosis.

## Clinical Evidence

Bench testing only. Validation included assessment of analytical performance parameters (LoB, LoD, LoQ, AMI) and correlation studies following the increase in sample volume from 3.5 μL to 10.5 μL. No clinical data presented.

## Technological Characteristics

Turbidimetric immunoassay; in vitro diagnostic reagent system. Operates on clinical chemistry analyzers. Modification: sample volume increased to 10.5 μL; includes Sample Probe Smart Wash feature. Analytical parameters updated: LoB, LoD, LoQ, AMI, correlation factor, read times, and sample stability.

## 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

- Quantia IgE ([K214068](/device/K214068.md) - original clearance)

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K214068

B Applicant

Biokit, S.A.

C Proprietary and Established Names

Quantia IgE

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  DGC | 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. 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, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

2. 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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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This change was to update the sample volume from 3.5 μL to 10.5 μL. Due to this modification, additional changes have been implemented: limit of blank (LoB), limit of detection (LoD), limit of quantification (LoQ), analytical measuring interval (AMI), the correlation factor, read times, and addition of Sample Probe Smart Wash. The sample stability is also updated.

3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

4. 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 (or their preamendment) device.

K214068 - Page 2 of 2

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K214068](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K214068)

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