ELECSYS INSULIN CALCHECK 5

K101075 · Roche Diagnostics Corp. · JJX · Jun 11, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101075
• Device Name: ELECSYS INSULIN CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers. The Elecsys Insulin CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys Insulin CalCheck 5 is a lyophilized, bovine serum-based control material containing recombinant human insulin. It is used by laboratory personnel on MODULAR ANALYTICS E170, Elecsys 2010, cobas e 601, and cobas e 411 analyzers. The device provides five concentration levels to verify the assay range and calibration of the Elecsys Insulin reagent. It is not a primary calibrator or routine control. Users reconstitute the material with distilled or deionized water before use. The device ensures the accuracy and linearity of insulin measurements within the clinical laboratory setting.

Clinical Evidence

No clinical data. Performance was established through bench testing, specifically evaluating value assignment and stability characteristics.

Technological Characteristics

Lyophilized product; recombinant human insulin in bovine serum matrix. Five-level concentration format. Reconstituted with 1.0 mL distilled or deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C after reconstitution. Designed for use on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Insulin reagent on specified Elecsys and cobas e immunoassay analyzers.

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 HCG+β CalCheck 5 (K092168)

Submission Summary (Full Text)

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

A. 510(k) Number:
k101075

B. Purpose for Submission:
New Device

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

D. Type of Test:
Not Applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys Insulin Calheck 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 Control (Assayed and Unassayed)
4. Panel
Clinical Chemistry

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H. Intended Use:

1. Intended use(s):

See indications for use below

2. Indication(s) for use:

The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers

3. Special conditions for use statement(s):

The Elecsys Insulin CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

4. Special instrument requirements:

The label states that Elecsys Insulin CalCheck 5 are for use with the Elecsys Insulin reagent on MODULAR ANALYTICS E170, Elecsys 2010, cobas e 601, and cobas e 411 immunoassay analyzers.

I. Device Description:

The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of recombinant human insulin in bovine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

J. Substantial Equivalence Information:

1. Predicate device

Elecsys HCG+β CalCheck 5

2. Predicate K number

k092168

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3. Comparison with predicate

Similarities

| Characteristic | Elecsys HCG+β CalCheck 5 (K092168) | Elecsys Insulin CalCheck 5 |
| --- | --- | --- |
| Indications for use | For use in calibration verification and for use in the verification of the assay range | Same |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling Instructions | Reconstitute the contents of each vial with exactly 1.0 mL distilled or deionized water. Allow the bottle to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity. | Same |
| Stability | Unopened: Store at 2-8°C until expiration date. Reconstituted: 20-25°C: 4 hours | Same |

Differences

| Characteristic | Elecsys HCG+β CalCheck 5 (k092168) | Elecsys Insulin CalCheck 5 |
| --- | --- | --- |
| Analyte | HCG+B | insulin |
| Matrix | Human Serum | Bovine Serum |

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

Non were referenced.

L. Test Principle:

Not Applicable

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 and Value Assignment

The Elecsys Insulin assay is standardized against the WHO Reference Reagent, 1st IRP, code 66/304 (NIBSC).

For each Insulin CalCheck 5 lot manufactured, the CalChecks were assayed in duplicate on the Elecsys MODULAR ANALYTICS E170, Elecsys 2010, cobas e 601, and cobas e 411 immunoassay 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.

Stability studies

Open-Vial Stability:

The on-test material was reconstituted and stored for 5 hours at 25°C (in an open vial).

The reference material was a freshly reconstituted set of CalChecks. The on-test and reference materials were tested in duplicate. On-test recovery was calculated as a percent of the reference. The protocol, data and acceptance criteria were found to be adequate.

The data supported the package insert claims that reconstituted Insulin CalCheck 5 is stable up to 4 hours at 20-25°C.

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Accelerated Stability:

The on-test material was stored lyophilized (as supplied to the user) at 35°C for 3 weeks. The reference material was freshly reconstituted set of CalChecks (stored at 4°C). After 3 weeks, the test and reference materials are tested in duplicate. The on-test recovery is calculated as a percent of the reference. The protocol, data and acceptance criteria were found to be adequate.

One Elecsys Insulin CalCheck 5 lot was evaluated in duplicate on the Elecsys 2010.

Real-Time Stability:

In addition to open-vial and accelerated stability, real-time stability was evaluated. In the on-going real-time stability study, the Elecsys Insulin CalCheck 5 test material is stored at 2-8°C. The CalChecks were tested at T=0 and at specified intervals over the shelf life of the device up to the planned shelf life plus one month.

The shelf life claim is 18 months. This is based on the accelerated stability results.

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

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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.

| Level | Target Value, μU/mL | Target Range, μU/mL |
| --- | --- | --- |
| Check 1 | ≤ 5 | NA |
| Check 2 | 20 | 15-20 |
| Check 3 | 500 | 450-550 |
| Check 4 | 800 | 720-880 |
| Check 5 | 1000 | 900-1000 |

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.