(50 days)
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No
The description details a standard immunoassay using electrochemiluminescence detection and calibration curves, with no mention of AI or ML technologies.
No
The device is an immunoassay for diagnosing allergic diseases by measuring IgE levels, and while it aids in diagnosis, it does not directly treat or prevent a disease, condition, or injury.
Yes
The intended use explicitly states, "Determination of total IgE is useful as an aid in the diagnosis of allergic diseases," which indicates its role in diagnosis.
No
The device is an immunoassay reagent kit intended for use on specific hardware analyzers (Roche Elecsys 2010 and MODULAR ANALYTICS E170). It involves physical reagents and a multi-step process on the analyzer, clearly indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma." The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Device Description: The description details a laboratory-based immunoassay process using reagents and analyzers, further supporting its use in a laboratory setting for diagnostic purposes.
- Purpose: The purpose is to aid in the diagnosis of allergic diseases by measuring IgE levels in patient samples. This is a diagnostic application.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JHR
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision studies were conducted using Elecsys 2010 and E170 analyzers, measuring intra-assay and total precision.
For Elecsys 2010:
Intra-assay CVs: 4.1% CV @ 32.7 IU/mL (HS1), 2.4% CV @ 265 IU/mL (HS2), 2.6% CV @ 1295 IU/mL (HS3).
Total CVs: 5.1% CV @ 32.7 IU/mL (HS1), 3.8% CV @ 265 IU/mL (HS2), 3.9% CV @ 1295 IU/mL (HS3).
For E170:
Intra-assay CVs: 1.4% CV @ 4.4 IU/mL (HS1), 0.7% CV @ 261 IU/mL (HS2), 1.0% CV @ 1018 IU/mL (HS3).
Total CVs: 2.7% CV @ 30.2 IU/mL (HS1), 2.8% CV @ 245 IU/mL (HS2), 3.4% CV @ 1207 IU/mL (HS3).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.10 IU/ml
Functional Sensitivity: 0.50 IU/ml
Precision metrics (CV%):
Elecsys 2010 Intra-assay: 4.1% (HS1), 2.4% (HS2), 2.6% (HS3)
Elecsys 2010 Total: 5.1% (HS1), 3.8% (HS2), 3.9% (HS3)
E170 Intra-assay: 1.4% (HS1), 0.7% (HS2), 1.0% (HS3)
E170 Total: 2.7% (HS1), 2.8% (HS2), 3.4% (HS3)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K061970
AUG 3 1 2006
510(k) Summary - Elecsys IgE II Immunoassay
| 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 |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: July 11, 2006 | |
| Device Name | Proprietary name: Elecsys IgE II immunoassay |
| Common name: IgE test | |
| Classification name: radioimmunoassay, immunoglobulins (d, e) | |
| 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. |
| Intended Use / 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. |
| Substantial equivalence | The Elecsys IgE II immunoassay is substantially equivalent to another device legally marketed in the United States. Elecsys IgE II (modified) assay is equivalent to the Elecsys IgE immunoassay (K984326, K961481/A003). Both products are intended for use in the quantitative determination of IgE in serum and plasma. |
| Device Comparison | The table below compares the device features of the Elecsys IgE II immunoassay (modified) and original (K984326, K961481/A003). |
Confidential
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1
510(k) Summary – Elecsys IgE II Immunoassay, continued
| 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 | 0.10-2500 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 |
| Interferences | No affect up to,
bilirubin