ELECSYS IGE II IMMUNOASSAY

K061970 · Roche Diagnostics · JHR · Aug 31, 2006 · Immunology

Device Facts

• Record ID: K061970
• Device Name: ELECSYS IGE II IMMUNOASSAY
• Applicant: Roche Diagnostics
• Product Code: JHR · Immunology
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Device Story

Elecsys IgE II is a two-step sandwich immunoassay using streptavidin-coated microparticles and electrochemiluminescence detection. Input: human serum or plasma samples. Process: sample reacts with biotinylated monoclonal antibody and ruthenium-labeled monoclonal antibody; streptavidin microparticles capture complex; electrochemiluminescence signal generated upon voltage application. Output: quantitative IgE concentration calculated via instrument-specific calibration curve and master curve. Used in clinical laboratory settings on Roche Elecsys 2010 or MODULAR ANALYTICS E170 analyzers. Results assist clinicians in diagnosing allergic diseases.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by analytical performance data, including precision (intra-assay and total CVs) and interference testing (bilirubin, hemoglobin, triglycerides, biotin).

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles. Reagents include biotinylated monoclonal antibody and ruthenium-labeled monoclonal antibody. Standardized against 2nd IRP WHO Reference Standard 75/502. Measuring range 0.100–2500 IU/mL. Analyzers: Roche Elecsys 2010 and MODULAR ANALYTICS E170.

Indications for Use

Indicated for in vitro quantitative determination of total IgE in human serum and plasma to aid in the diagnosis of allergic diseases. For prescription use only.

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.

Predicate Devices

• Elecsys IgE immunoassay (K984326, K961481/A003)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k061970

B. Purpose for Submission:
Modification to the manufacturer’s existing device including changes to a strictly monobiotinylated monoclonal antibody (the antibody itself remains unchanged), deletion of an application for the Elecsys 1010 analyzer and modifications to specifications for linearity, intra-assay and inter-assay precision.

C. Measurand:
Quantitative determination of IgE in human serum and plasma

D. Type of Test:
Immunoassay

E. Applicant:
Roche Diagnostics.

F. Proprietary and Established Names:
Elecsys IgE II immunoassay

G. Regulatory Information:
1. Regulation section:
21 CFR 866.5510, Immunoglobulins A, G, M, D and E Immunological test system
2. Classification:
Class II
3. Product code:
JHR, Radioimmunoassay, Immunoglobulins (D, E)
4. Panel:
Immunology (82)

H. Intended Use:
1. Intended use(s):
Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases.
2. Indication(s) for use:
Same as Intended Use
3. Special conditions for use statement(s):
For Prescription use only
4. Special instrument requirements:

I. Device Description:
The Elecsys IgE II immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.

J. Substantial Equivalence Information:
1. Predicate device name(s):

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Elecsys IgE immunoassay

2. Predicate 510(k) number(s):
(K984326, K961481/A003)

3. Comparison with predicate:

| Topic | Elecsys IgE (K984326, K961481/A003) | Elecsys IgE II (Modified Device) |
| --- | --- | --- |
| Intended use | Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. | Same |
| Analyzers | Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. | Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
| Traceability | Assay standardized against the 2nd IRP WHO Reference Standard 75/502 | Same |
| Assay Protocol | Sandwich | Same |
| Sample Type | Serum and plasma | Same |
| Calibrator, Calibration Verification & Controls | IgE CalSet
IgE CalCheck
PreciControl Universal | Same |
| Measuring Range | 0.100 – 2500 IU/ml | Same |
| Analytical Sensitivity | 0.10 IU/ml | Same |
| Functional Sensitivity | 0.50 IU/ml | Same |
| Composition | R1: 2.4 mg/L AB-Bi, buffer, preservative
R2: 4.8 mg/L AB-Ru, buffer, preservative
M: 0.72 mg/ml streptavidin-coated microparticles, preservative | R1: 2.5 mg/L (mono-Bi)AB-Bi, buffer, preservative
R2: 5.5 mg/L AB-Ru, buffer, preservative
M: 0.72 mg/ml streptavidin-coated microparticles, preservative |
| Dilution Recommendation | Concentration of diluted samples must be > 60 IU/mL | Concentration of diluted samples must be > 125 IU/mL |

K. Standard/Guidance Document Referenced (if applicable):

L. Test Principle:
Same

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:

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Special 510(k): Device Modification - Elecsys IgE II Immunoassay, continued

| Topic | Elecsys IgE (K984326, K961481/A003) | Elecsys IgE II (Modified Device) |
| --- | --- | --- |
| Interferences | No affect up to,
bilirubin < 37 mg/dl
hemoglobin < 1.1 g/dl
triglycerides < 2200 mg/dl
biotin < 100 ng/ml | No affect up to,
Bilirubin - Same
hemoglobin < 0.1 g/dl
triglycerides - Same
biotin - Same |
| Precision | Elecsys 1010 / 2010:
Intra-assay
HS1 3.6% CV @ 5.18 IU/mL
HS2 3.2% CV @ 398 IU/mL
HS3 2.4% CV @ 1010 IU/mL
Total:
HS1 4.2% CV @ 5.18 IU/mL
HS2 3.9% CV @ 398 IU/mL
HS3 3.1% CV @ 1010 IU/mL | Elecsys 2010:
Intra-assay:
HS1 4.1% CV @ 32.7 IU/mL
HS2 2.4% CV @ 265 IU/mL
HS3 2.6% CV @ 1295 IU/mL
Total:
HS1 5.1% CV @ 32.7 IU/mL
HS2 3.8% CV @ 265 IU/mL
HS3 3.9% CV @ 1295 IU/mL |

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

d. Detection limit:
Same

e. Analytical specificity:
Same

f. Assay cut-off:
Not applicable.

2. Comparison studies:
a. Method comparison with predicate device:
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
No change.
b. Clinical specificity:
No change.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
N. Software:

O. Proposed Labeling:

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P. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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