K Number
K984326
Device Name
ELECYS IGE ASSAY
Date Cleared
1999-02-08

(67 days)

Product Code
Regulation Number
866.5510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.
Device Description
The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.
More Information

K/DEN: Not Found

Not Found

No
The description details a standard immunoassay based on electrochemiluminescence and does not mention any AI or ML components.

No.
The device is used for in vitro quantitative determination of immunoglobulin E in human serum and plasma, which aids in the diagnosis of allergic disease, but does not treat the disease itself.

Yes

This device is a diagnostic device because its "Intended Use" states it is "useful as an aid in the diagnosis of allergic disease."

No

The device is an in vitro diagnostic (IVD) test kit that utilizes chemical reagents and is intended for use on specific hardware analyzers (Boehringer Mannheim Elecsys 1010 and 2010). It is not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states "For in vitro quantitative determination of immunoglobulin E in human serum and plasma." This clearly indicates the device is used to test samples taken from the body (in vitro) to diagnose or monitor a condition.
  • Device Description: The description details an "electrochemiluminescence immunoassay" which is a laboratory-based test method performed on biological samples.
  • Purpose: The determination of total serum IgE is stated as being "useful as an aid in the diagnosis of allergic disease," which is a diagnostic purpose.

These points align directly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
An aid in the diagnosis of allergic diseases.

Product codes

JHR

Device Description

The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation.
First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex
Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Precision:
Within-Run %CV
3.6% at 5.18 IU/mL
2.1% at 105 IU/mL
2.8% at 197 IU/mL
3.2% at 398 IU/mL
2.4% at 1010 IU/mL

Total %CV
4.2% at 5.18 IU/mL
1.9% at 105 IU/mL
3.9% at 197 IU/mL
3.9% at 398 IU/mL
3.1% at 1010 IU/mL

Lower Detection Limit: 0.10 IU/mL
Measuring Range: 0.10-4000 IU/ml
Specificity: No cross-reactivity with the immunoglobulins G, A and M was detected.
Method comparison, Elecsys IgE vs Enzymun-Test IgE, N=188
Passing/Bablok: y = -0.53 + 0.97x, r = 1.0, SD (md68) = 2.42
Linear regression: y = -1.85 + 1.01x, r = 1.0, Sy.x = 5.86
Interfering substances: No interference at:
Bilirubin

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).

0

.

510(k) Summary

·

| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter
name, address,
contact | Roche Diagnostics, doing business in the US as Roche Diagnostics
9115 Hague Rd
Indianapolis, IN 46250
(317) 576-3723 | | |
| | Contact person: Priscilla A. Hamill | | |
| | Date prepared: December 2, 1998 | | |
| Device name | Proprietary name: Elecsys® IgE Test | | |
| | Common name: IgE | | |
| | Classification name: Immunoglobulins A, G, M, D, and E immunological
test system | | |
| Predicate
device | We claim substantial equivalence to the Boehringer Mannheim Enzymun-
Test® IgE. | | |
| Device
description | The Elecsys® IgE test is based on the sandwich principle of heterogeneous
immunological complex formation. | | |
| | First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled
antibodies (R2), both specific for IgE, bind IgE present in the sample forming
a sandwich complex
Second Step: Microparticles coated with streptavidin (M) bind the biotin
portion of the complex and are captured magnetically onto the surface of the
electrode. Application of a voltage to the electrode induces chemiluminescent
emission, which is measured by a photomultiplier. | | |

02/04/99

1

510(k) Summary, Continued

Intended use

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Comparison to the predicate device

Similarities: The following table compares Boehringer Mannheim ® IgE Test with the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5. Labeling for the predicate device is provided in Attachment 6.

| Feature | Elecsys® IgE Test | Enzymun-
Test® IgE. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended use | For the quantitative determination of IgE in human serum and plasma on the Elecsys 1010 and 2010 immunoassay analyzers. | For the quantitative determination of IgE in human serum and plasma on automated immunoassay analyzers |
| Indications for use | An aid in the diagnosis of allergic diseases | An aid in the diagnosis of allergic diseases |
| Sample type | Human serum, plasma | Human serum, plasma |
| Assay reaction principle | Sandwich principle, Heterogeneous immunological complex formation | Sandwich principle, Heterogeneous immunological complex formation, ELISA |
| Standardized against | WHO Standard | WHO Standard |

Continued on next page

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2

510(k) Summary, Continued

Comparison to the predicate device (cont.)

Differences: The following differences between Elecsys® IgE Test and the predicate device are not significant for purposes of determining substantial equivalence.

FeatureElecsys® IgE TestEnzymun-Test® IgE.
Measurement approachElectrochemiluminescencePhotometric
Instrument requiredBoehringer Mannheim Elecsys automated immunoassay analyzerBoehringer Mannheim ES 300/300 AL automated immunoassay analyzers
Reagent FormulationLiquid; ready to useLyophilized; reconstitution required

Performance characteristics: The performance of the Elecsys® IgE Test is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test® IgE.

FeatureElecsys® IgE TestEnzymun-Test® IgE.
PrecisionWithin-Run %CV
3.6% at 5.18 IU/mL
2.1% at 105 IU/mL
2.8% at 197 IU/mL
3.2% at 398 IU/mL
2.4% at 1010 IU/mL

Total %CV
4.2% at 5.18 IU/mL
1.9% at 105 IU/mL
3.9% at 197 IU/mL
3.9% at 398 IU/mL
3.1% at 1010 IU/mL | Within-Run %CV
2.1% at 102.7 IU/mL
2.1% at 244.1 IU/mL
2.8% at 375.4 IU/mL

Total %CV
3.4% at 102.7 IU/mL
3.4% at 244.1 IU/mL
3.6% at 375.4 IU/mL |
| Lower
Detection
Limit | 0.10 IU/mL | 1.44 IU/mL |
| Measuring
Range | 0.10-4000 IU/ml | 1.44-500 IU/ml |

3

510(k) Summary, Continued

Comparison to the predicate device (cont.)

Performance characteristics: continued

FeatureElecsys® IgE TestEnzymun-Test® IgE.
SpecificityNo cross-reactivity with the
immunoglobulins G, A and M was
detected.No cross-reactions with IgG,
IgA and IgM was detected.
Method
comparisonElecsys IgE vs Enzymun-Test IgE

Passing/Bablok
y = -0.53 + 0.97x
r = 1.0
SD (md68) = 2.42
N = 188

Linear regression
y = -1.85 + 1.01x
r = 1.0
Sy.x = 5.86
N = 188 | |
| Interfering
substances: | No interference at: | No interference at: |
| Bilirubin
Hemoglobin
Lipemia
Biotin |