← Product Code [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF) · K033187

# INTERLAB IMMUNOFIXATION TEST(S) (K033187)

_Interlab S.R.L. · CFF · Nov 19, 2003 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033187

## Device Facts

- **Applicant:** Interlab S.R.L.
- **Product Code:** [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF.md)
- **Decision Date:** Nov 19, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.

## Device Story

System performs immunofixation electrophoresis to identify monoclonal gammopathies; utilizes cellulose acetate membranes supported on Mylar; processes human serum and concentrated urine samples. Operates on Microtech 672 PC and IFX 600 instruments. Intended for clinical laboratory use by trained personnel. Device separates proteins via electrophoresis; applies specific antisera to identify immunoglobulin classes and light chains. Output consists of electrophoretic patterns for visual interpretation by laboratory professionals to aid in clinical diagnosis of monoclonal gammopathies.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

System utilizes cellulose acetate membranes supported on Mylar. Electrophoresis-based separation principle. Designed for use with Microtech 672 PC and IFX 600 instruments. In vitro diagnostic use.

## 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.

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033187

B. Analyte:
Immunoglobulins A, G, and M
Lambda and Kappa chains

C. Type of Test:
Immunofixation electrophoresis
Qualitative

D. Applicant:
InterLab Scientific Instruments srl
Via Rina Monti N 26 C.A.P.
Rome, 00155
Italy

E. Proprietary and Established Names:
InterLab Immunofixation Electrophoresis Test System

F. Regulatory Information:
1. Regulation section:
866.5510 Immunoglobulins A, G, M, D, and E
Immunological test system
866.5150 Bence-Jones Proteins Immunological test system
2. Classification:
Class II
3. Product Code:
CFF Immunoelectrophoretic, Immunoglobulins (G, A, M)
JKM Immunochemical, Bence-Jones Protein
4. Panel:
Immunology

G. Intended Use:
1. Indication(s) for use:
InterLab Immunofixation Test is for the qualitative in vitro diagnostic
separation and identification of abnormal immunoglobulins and kappa and
lambda chains in human serum and concentrated urine using cellulose acetate

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supported on Mylar® for the Microtech 672 PC and IFX instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.

2. Special condition for use statement(s):
NA

3. Special instrument Requirements:
Cellulose Acetate supported on Mylar for the Microtech 672 PC and IFX 600 instruments. The Microtech 672 PC and IFX 600 employ the use of a robotic arm that moves the strip to the different stations. The instruments are offered as "open" systems and other manufacturer's electrophoresis strips and reagents can be used with the instruments. The Microtech 672 can be used for other electrophoretic separations and IFX 600 only does immunofixation. These instruments are considered class I Exempt based on CFR 866.4500, product code JZS and CFR 862.2485, product code JJN

H. Device Description:
The InterLab Immunofixation Test provides identification of immunoglobulin bands visualized by staining of the separated fractions. The kit contains materials for 24 runs. The kit contains the following: Slides, Running Buffer, Staining solution, Destaining A solution, Destaining B solution, Washing solution, Storing solution, Antisera which contain monospecific mammalian (goat or rabbit) antibodies raised against human IgG, IgM, IgA, kappa and lambda chains, and Fixative. All reagents are ready to use except the Destaining solution. A working destaining solution is prepared by combining equal volume of Destaining solutions A and B.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Paragon Serum Immunofixation test (Beckman Coulter)
Sebia Hydragel Bence Jones Kit
2. Predicate K number(s):
K002799
K972591
3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Microtech 672 & IFX 600 | Paragon IFE & Sebia system  |
|  Methodology | Immunofixation through precipitin formation following protein separation by electrophoresis | Same  |
|  Sample type | Serum and Urine | Same  |
|  Operating system | Electrophoresis using a gel/membrane strip | Same  |
|   |  System perform processing steps | Same  |

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|   | for visualization of the sample, but require a technician to read and interpret results |   |
| --- | --- | --- |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Medium for electrophoresis | Cellulose acetate supported on Mylar | Agarose gel  |
|  Instrument component | Use of robotic arm to move the strip to the different station | Totally manual set-up  |

J. Standard/Guidance Document Referenced (if applicable): NA

K. Test Principle:
Immunofixation electrophoresis is based on visualization of specific proteins through antigen-antibody precipitin formation following protein separation by electrophoresis. Dilutions of patient’s specimen are placed on separate tracks (fingers) of a cellulose acetate six finger shaped slide. The major protein groups are separated by electrophoresis. One of the fingers of the slide is treated with a chemical fixative solution to fix all proteins and create an electrophoresis reference pattern for the specimen. The other fingers of the slide are immunofixed by antisera with different specificities: IgG, IgA, IgM heavy chains; anti-kappa and anti-lambda (free and bound) light chains. The migration rate depends on the temperature, pH, ionic strength of the solutions and proportion of the reactants. After immunofixation, the slide is washed to remove any excess soluble protein. The separated complexes are then stained to visualize the bands.
Normal samples do not contain monoclonal components. By comparing the locations of stained immunofixed bands with a band of the same location in the reference protein electrophoretic pattern, a specific protein is identified.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
An abnormal control, a pooled serum sample and a pooled urine sample were run in duplicate runs and duplicate lots to demonstrate reproducibility of the test. The abnormal control contained IgM, lambda monoclonal band of approximately 10g/L.
Pooled serum were prepared by mixing three different types of sera each containing monoclonal IgG, IgM, IgA, with kappa and lambda light chains. The final nominal concentration of each monoclonal immunoglobulin type was 5 g/L. Each pool was diluted before use. Pooled urine were prepared by mixing two different types of urine, each containing a monoclonal light chain (Bence-Jones protein), either kappa or lambda.

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The multiple patterns were visually inspected and found to be qualitatively identical. The bands are correctly identified. No false negative or positives were observed.

b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method): NA
d. Detection limit: NA
e. Analytical specificity: Interference:

A statement was included in the package insert regarding the use of hemolyzed or lipemic samples in the test. Because interference may vary from sample to sample, it was recommended that: "Fresh serum samples without hemolysis or lipemia are the optimal choice for testing." This is based on accepted practice and published literature. The sponsor also provided examples of lipemic and hemolyzed sample showing bands are detectable.

Example 1 – Lipemic sample with monoclonal band - A lipemic serum was spiked with sera containing IgM kappa and lambda respectively. The effect of higher titer of lipids is shown by the increased background spanning the alpha 1, alpha 2 and beta bands. Mark of application point is evident in the antisera tracks and prozone effect is displayed in some immunofixed bands, due to excess antigen. The monoclonal band is still detectable.

Example 2 – Serum sample with marked hemolysis - A grossly hemolyzed sample with a monoclonal band was used. The hemoglobin-haptoglobin complex appears as a large band, close to the beta band. The monoclonal band(s) is still detectable.

f. Assay cut-off: NA

2. Comparison studies:

a. Method comparison with predicate device:

Studies were performed using 40 serum samples and 20 urine samples from both normal and suspected pathological patients. The samples contained a mixture of IgG, IgM, IgA, kappa and lambda fractions. From the 40 sera, 10 were from normal patients. The serum samples were evaluated with the InterLab IFE electrophoresis test system and the Paragon IFE gel method. Of the 20 urine samples, 2 were from normal patients. The urine samples were tested using the InterLab IFE test system and the SEBIA Hydragel IF gel. A normal and abnormal control was used in each run to assess that the correct migration pattern was obtained.

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The device demonstrated  $100\%$  agreement to the predicate device in identifying equivalent band patterns. Neither method detected bands in the normal patients.

InterLab used two different labs to obtain the number of samples.

The lab that did the serum used the Paragon system but did not have enough urine samples. Hence another lab using the Sebia instrument was used to gather the urine data

Clinical disease states of the patients were not included in the correlation study.

|   | Predicate device |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive | 50 | 0 | 50  |
|  Negative | 0 | 10 | 10  |
|  Total | 50 | 10 | 60  |

Relative Sensitivity  $100\%$  (serum and urine)

Relative specificity  $100\%$  (serum and urine)

Relative Agreement  $100\%$  (serum and urine)

b. Matrix comparison:

Throughout the method comparison study, a  $100\%$  correlation was obtained for the serum and urine to the predicate devices. A photograph of the electrophoretic pattern of a matched patient sample {serum and urine with kappa light chain (Bence-Jones)} run on the InterLab was provided.

3. Clinical studies:

a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when  $a$  and  $b$  are not applicable): NA

4. Clinical cut-off: NA

5. Expected values/Reference range:

Normal samples do not contain monoclonal components. In monoclonal gammopathies, IFE yields a distinct, sharply defined precipitin band.

# M. Conclusion:

Based on the review of the information provided in this 510(k), the InterLab Immunofixation Test appears to be Substantially Equivalent to devices regulated under 21CFR866.5510 Immunoglobulins A, G, M, D, and E immunological test system, product code CFF, and 21 CFR 866.5150 Bence-Jones Proteins immunological test system, product Code JKM.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033187](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033187)

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