← Product Code [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN) · K233663

# N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663)

_Siemens Healthcare Diagnostics Products GmbH · CFN · Dec 13, 2023 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K233663

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics Products GmbH
- **Product Code:** [CFN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN.md)
- **Decision Date:** Dec 13, 2023
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

In-vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Device Story

In-vitro diagnostic reagent kit for quantitative immunonephelometric analysis of immunoglobulins. Input: human serum, heparinized/EDTA plasma, urine, or CSF samples. Principle: proteins in sample form immune complexes with rabbit-derived anti-human IgG antibodies; complexes scatter light beam; scattered light intensity proportional to protein concentration. Output: quantitative concentration result compared against known standard. Used in clinical laboratories; operated by trained technicians on BN II or BN ProSpec systems. Provides clinicians with quantitative data to aid diagnosis of abnormal protein metabolism and immune system function. Modification adds High Dose Hook (HDH) effect claim for CSF samples (up to 1130 mg/L) to ensure accurate reporting at high concentrations.

## Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm the high dose hook effect claim for CSF samples. No clinical data required for this labeling modification.

## Technological Characteristics

Liquid reagent containing rabbit-derived anti-human IgG antibodies and sodium azide preservative. Principle: immunonephelometry. Analyzers: BN II and BN ProSpec systems. Traceability: ERM-DA470k/IFCC. Storage: 2-8°C. No changes to formulation, instrument parameters, or fundamental technology.

## 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

- N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) ([K233663](/device/K233663.md) - previously cleared version)

## 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

K233663

B Applicant

Siemens Healthcare Diagnostics Products GmbH

C Proprietary and Established Names

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

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. (For a preamendments device, a statement to this effect has been provided.)
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, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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This change was for a labeling modification to include a new high dose hook effect claim for N Antiserum to Human Immunoglobulins IgG for cerebrospinal fluid (CSF) samples.

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 (or their preamendment) device.

K233663 - Page 2 of 2

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K233663](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K233663)

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