ELECSYS IGE CALCHECK 5

K102269 · Roche Diagnostics · JJX · Oct 7, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102269
• Device Name: ELECSYS IGE CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys IgE CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys IgE II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys IgE CalCheck 5 is a lyophilized, human serum-based control material containing human Immunoglobulin E (IgE). It is used in clinical laboratory settings to verify calibration and assay range for the Elecsys IgE II reagent on Roche immunoassay analyzers (MODULAR ANALYTICS E170, cobas e 601, Elecsys 2010, cobas e 411). The product consists of 5 levels of IgE concentrations. Laboratory technicians reconstitute the lyophilized material with distilled or deionized water before use. The device provides target values and ranges that allow clinicians to confirm that the immunoassay system is performing within established specifications. This verification process ensures the accuracy of patient IgE test results, supporting clinical decision-making in allergy and immunology diagnostics.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through open-vial (4 hours at 20-25°C), accelerated (3 weeks at 35°C), and real-time studies. Value assignment was performed using duplicate runs on at least three E170 analyzers, with traceability to the 2nd IRP WHO Reference Standard 75/502. Dilution studies confirmed recovery within the assay measuring range (0.100 - 2500 IU/mL).

Technological Characteristics

Lyophilized human serum matrix containing human IgE. Five-level concentration set. Reconstituted with 1.0 mL distilled/deionized water. Standardized against 2nd IRP WHO Reference Standard 75/502. Storage: 2-8°C unopened; 4 hours at 20-25°C reconstituted. Compatible with MODULAR ANALYTICS E170, cobas e 601, Elecsys 2010, and cobas e 411 analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys IgE II reagent on specified immunoassay analyzers. For prescription use only. For in vitro diagnostic use. Not intended as a primary calibrator or control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys IgE CalCheck (k984419)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k102269

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification and assay range verification material for IgE

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys IgE CalCheck 5

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660, Quality Control Material (Assayed and Unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJX – Single (Specified) Analyte Controls (Assayed and Unassayed)
4. Panel:
Immunology

H. Intended Use:
1. Intended use(s):
The Elecsys IgE CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys IgE II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
2. Indication(s) for use:
See Intended Use
3. Special conditions for use statement(s):
For prescription use only. For in vitro diagnostic use. The Elecsys IgE CalCheck 5 is not intended to be used as a primary calibrator or control material.
4. Special instrument requirements:
MODULAR ANALYTICS E170, cobas e 601, Elecsys 2010, cobas e 411 analyzers

I. Device Description:
The Elecsys IgE CalCheck 5 is a lyophilized product consisting of human Immunoglobulin E (IgE) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Each set contains 5 lyophilized levels: Each bottle, reconstituted to 1.0 mL; Reactive ingredient (after reconstitution): IgE (human) in human serum matrix. Level 1 contains no analyte.

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| Level | Target Value [IU/mL] | Target Range [IU/mL] |
| --- | --- | --- |
| Check 1 | ≤ 0.1 | – |
| Check 2 | 100 | 79 - 121 |
| Check 3 | 1225 | 968 - 1482 |
| Check 4 | 2000 | 1580 - 2420 |
| Check 5 | 2500 | 1975 - >2500 |

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient specimen.

## J. Substantial Equivalence Information:

1. Predicate device name(s): Elecsys IgE CalCheck
2. Predicate K number(s): k984419
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | New Device (k102269) | Predicate (k984419) |
| Intended Use | For use in calibration verification and for use in the verification of the assay range established by the Elecsys IgE II reagent on the indicated Elecsys and cobas e immunoassay analyzers | For use in the verification of the calibration established by the Elecsys IgE reagent and CalSet on Elecsys 1010 or 2010 immunoassay analyzers. |
| Analyte Measured | Human Immunoglobulin E | Same |
| Format of Reagent | Lyophilized | Same |
| Matrix | Human Serum | Same |
| Differences | | |
| --- | --- | --- |
| Item | New Device (k102269) | Predicate (k984419) |
| Number of Levels | 5 levels | 3 levels |
| Reagent Handling Instructions | Reconstitute the contents of Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow the bottles to | Reconstitute the contents of Check 1 with exactly 1 mL distilled or deionized water. Allow the bottle to stand closed for 15 minutes. Mix |

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| Differences | | |
| --- | --- | --- |
| Item | New Device (k102269) | Predicate (k984419) |
| | stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity. | gently by inversion to ensure homogeneity. Prepare Checks 2 and 3 in the same manner as for Check 1 above. |
| Stability of Reagent | **Unopened:**
•Store at 2-8°C until expiration date
**Reconstituted:**
•20-25°C: 4 hours | **Unopened:**
•Store at 2-8°C until expiration date
**Reconstituted:**
•15-25°C: 4 hours |

K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material

L. Test Principle:
Calibration verification is not a requirement of the Elecsys and cobas e immunoassay systems based on the manufacturer’s recommendations.
However, in instances where such a test procedure is required by certification agencies, or where the user wishes to document calibration verification, these CalCheck 5 solutions are used for such testing.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
This method has been standardized against the 2nd IRP WHO Reference Standard 75/502.
Expected Values and Value Ranges
For each Elecsys IgE CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzers. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. (i.e. Elecsys 2010 and E170). Pre-determined acceptance criteria for IgE recovery must be met for each control lot. The target value for each CalCheck is the median of the observed values. IgE expected values and value ranges are lot dependent and are listed in the lot-specific value sheet. Test results must fall within the range printed on the lot-specific value sheet. The labeling states that laboratories should establish appropriate acceptance criteria when using this product for its intended use.

Value Assignment

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| Level | Target Value (IU/mL) | Assigned Value (IU/mL) |
| --- | --- | --- |
| Check 1 | ≤0.1 | <0.1 |
| Check 2 | 100 | 98.4 |
| Check 3 | 1225 | 1130 |
| Check 4 | 2000 | 1880 |
| Check 5 | 2500 | 2460 |

# Stability

# Open-Vial Stability Studies

The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 5 hours at $25^{\circ}\mathrm{C}$ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percentage of the reference value. The reconstituted vials are stable for four hours at $20 - 25^{\circ}\mathrm{C}$

# Accelerated Stability:

The on-test material was stored lyophilized (as supplied to the user) at $35^{\circ}\mathrm{C}$ for 3 weeks. The reference material was a freshly reconstituted set of CalChecks stored at $2 - 8^{\circ}\mathrm{C}$ . After 3 weeks, the test and reference materials were tested in duplicate. The on-test recovery was calculated as a percentage of the reference value. Accelerated stability testing supports the target shelf life claim of 18 months

# Real-Time Stability:

In the on-going real-time stability study, the Elecsys IgE CalCheck 5 test material is stored at $2 - 8^{\circ}\mathrm{C}$ . The CalChecks are tested at $\mathrm{T} = 0$ and at specified intervals over the shelf life of the device up to the planned shelf life plus one month. The manufacturer claims CalCheck 5 is stable until the expiration date printed on the vial when stored unopened at $2 - 8^{\circ}\mathrm{C}$ .

# Dilution Study:

To demonstrate that the values are within the assay's measuring range of $0.100 - 2500\mathrm{IU / mL}$ after mixing, the following dilution study was performed on Elecsys IgE CalCheck 5 Levels 1 and 5: Check 1 &amp; Check 2 and Check 4 &amp; Check 5 were mixed in a 1:1 ratio and measured in two-fold determination. The average was then calculated.

| Sample | Value after 1:1 Dilution [IU/mL] | Average 1:1 Dilution [IU/mL] |
| --- | --- | --- |
| E170/e 601 | | |
| Check 1 + Check 2 | 48.7 | 48.6 |
| Check 1 + Check 2 | 248.4 | |
| Check 4 + Check 5 | 2246 | 2274 |
| Check 4 + Check 5 | 2302 | |
| 2010/e 411 | | |
| Check 1 + Check 2 | 50.7 | 49.4 |

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| Check 1 + Check 2 | 48.0 | |
| --- | --- | --- |
| Check 4 + Check 5 | 2274 | 2250 |
| Check 4 + Check 5 | 2225 | |

d. Detection limit:
Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

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

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
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:
The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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