ELECSYS T3 CALCHECK 5

K111552 · Roche Diagnostics · JJX · Jul 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111552
• Device Name: ELECSYS T3 CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys T3 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 T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Device Story

Elecsys T3 CalCheck 5 is a lyophilized, human serum-based control material containing spiked L-3,3,5-Triiodothyronine (T3). Used in clinical laboratory settings on Elecsys and cobas e immunoassay analyzers (e.g., 2010, E170, e411, e601, e602). Operators are laboratory technicians. The device is reconstituted with distilled/deionized water and processed by the analyzer to verify calibration and assay measuring range. Output consists of measured T3 concentrations compared against target values/ranges provided by the manufacturer. This verification ensures the accuracy and reliability of patient T3 test results, aiding clinicians in diagnosing and monitoring thyroid function.

Clinical Evidence

No clinical data. Performance evaluation limited to bench testing for value assignment and stability.

Technological Characteristics

Lyophilized human serum matrix; T3 analyte; five concentration levels; reconstituted with 1.0 mL distilled/deionized water; stored at 2-8°C unopened; stable for 4 hours at 20-25°C after reconstitution. Used 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 T3 quantitative assay on Elecsys and cobas e immunoassay analyzers. Prescription use only.

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 T3 CalCheck (K963167)

Submission Summary (Full Text)

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

A. 510(k) Number:
k111552

B. Purpose for Submission:
New device

C. Measurand:
Assayed control materials for L-3,3,5-Triiodothyronine (T3)

D. Type of Test:
Quality control materials

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys T3 CalCheck 5

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 21 CFR 862.1660
Quality Control Material | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Refer to indication for use below.

2. Indication(s) for use:
The Elecsys T3 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 T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

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3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Elecsys and cobas e immunoassay analyzers including the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 analyzer platforms.

Note: cobas e 411 share the same analytical core as Elecsys 2010; cobas e 601, and cobas e 602 share the same analytical core as E170.

I. Device Description:

The Elecsys T3 CalCheck 5 is a lyophilized product consisting of L-3,3,5-Triiodothyronine (T3) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. The sponsor declared in the labeling that 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.

During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Target Values and Ranges for Elecsys T3 CalCheck 5

| Level | Target Value (ng/mL) | Target Value (nmol/L) | Target Range (ng/mL) | Target Range (nmol/L) |
| --- | --- | --- | --- | --- |
| Check 1 | ≤ .13 | < 0.2 | - | - |
| Check 2 | 1.30 | 2.0 | 1.11-1.50 | 1.7-2.3 |
| Check 3 | 3.26 | 5 | 2.93-3.58 | 4.5-5.5 |
| Check 4 | 5.21 | 8 | 4.69-5.73 | 7.2-8.8 |
| Check 5 | 6.51 | 10 | 5.79-7.16 | 8.9-11.0 |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Elecsys T3 CalCheck

2. Predicate 510(k) number(s):

K963167

3. Comparison with predicate:

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| Characteristic | Elecsys T3 CalCheck 5
(New Device) | Elecsys T3 CalCheck
(Predicate Device) |
| --- | --- | --- |
| Similarities | | |
| Intended Use/
Indications for use | Same | For use in the verification of the calibration
established by the Elecsys T3 regent on
Indicated Elecsys and Cobas e
immunoassay analyzers. |
| Format | Same | Lyophilized |
| Matrix | Same | Human serum |
| Handling | Same | Reconstitute with exactly 1.0 mL
distilled or deionized water. Allow to stand
closed for 15 minutes, then mix gently by
inversion. |
| Unopened Stability | Same | Store at 2-8°C until expiration date |
| Assay Measuring
Range | Same | 0.19 – 6.51 ng/mL |
| Differences | | |
| Levels | 5 | 3 |
| Reconstituted
Stability | 20-25 °C, 4 hours | 15-25 °C, 4 hours |
| Target Values | Check 1: < 0.13 ng/mL
Check 2: 1.3 ng/mL
Check 3: 3.26 ng/mL
Check 4: 5.21 ng/mL
Check 5: 6.51 ng/mL | Check 1: 0 ng/mL
Check 2: 1.6 ng/mL
Check 3: 5.8 ng/mL |

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

None 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):

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# Traceability

The assayed value of each CalCheck level was standardized against reference standards by weighing T3 into an analyte-free human serum matrix. The reference standard used was T3, BCR® certified Reference Material, from a commercial vendor. BCR is a registered trademark of the European Commission.

# Value Assignment:

For each Elecsys T3 CalCheck 5 lot manufactured, the CalChecks are assayed in duplicate on four E170 analyzers. The assigned value of each CalCheck is defined as the median value obtained from 8 determinations of the respective CalCheck. The assigned range is $\pm 18\%$ of assigned value, in which $10\%$ was allotted for between-analyzer platform tolerance, $4\%$ for stability tolerance and $4\%$ for precision of the assay.

Values are assigned for each lot of Elecsys T3 CalCheck 5 in combination with each Elecsys T3 reagent lot available.

For additional analyzers (Elecsys 2010), The Elecsys T3 CalCheck 5 was run once a day on 8 Elecsys 2010 analyzers for a total of 1 day. The assigned values obtained on Elecsys 2010 are compared to those obtained on the E170. Differences between the analyzer platforms are within the $10\%$ tolerance, therefore, the values assigned to the E170 (and cobas e 601, e602) are transferred to and valid for the Elecsys 2010 (and cobas e 411).

# Stability:

The stability studies for T3 CalCheck 5 were performed on Elecsys 2010. Because these studies are not analyzer-dependent, these results, in addition to real-time stability study results, can be applied to the MODULAR ANALYTICS E170, cobas e 411, cobas e 601 and cobas e 602. The stability protocol and the acceptance criteria have been reviewed and found to be acceptable.

- Shelf-life stability: The accelerated stability testing performed at $35^{\circ}\mathrm{C}$ supports an initial shelf-life claim of 24 months at $2 - 8^{\circ}\mathrm{C}$. Real-time testing at $2 - 8^{\circ}\mathrm{C}$ is on-going to support a claim of 36 months.

- Open-vial stability after reconstitution: Real time testing was performed and the data support the package insert claim that reconstituted Elecsys T3 CalCheck 5 is stable up to 4 hours at $20 - 25^{\circ}\mathrm{C}$.

- On-board stability: The T3 CalCheck 5 products are not stored on-board the analyzer, therefore no onboard stability claims is made.

d. Detection limit:

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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:
Not applicable

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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.

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