ELECSYS SHBG CALCHECK 5

K111349 · Roche Diagnostics · JJX · Jun 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111349
• Device Name: ELECSYS SHBG CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

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

Device Story

Elecsys SHBG CalCheck 5 is a lyophilized, assayed control material containing SHBG in a human and equine serum matrix; used for calibration verification and assay range verification of Elecsys SHBG quantitative assays on Elecsys and cobas e immunoassay analyzers. Device is intended for professional use in clinical laboratory settings. Healthcare providers use the output to verify that the immunoassay analyzer is performing within established measurement ranges, ensuring accuracy of patient SHBG test results. Benefits include improved reliability of diagnostic testing for SHBG levels.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed on E170 and 2010 analyzers; stability studies (shelf-life and open-vial) performed on cobas e 601.

Technological Characteristics

Lyophilized human and equine serum matrix; spiked with SHBG analyte. Reconstituted with 1.0 mL distilled/deionized water. Traceable to NIBSC 95/560. Stability: 18-month shelf-life at 2-8°C; 4-hour open-vial stability at 20-25°C. Compatible with Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys SHBG quantitative assay 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 SHBG CalCheck (K031698)

Submission Summary (Full Text)

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

A. 510(k) Number:
k111349

B. Purpose for Submission:
New device

C. Measurand:
Assayed control materials for Sex Hormone – Binding Globulin (SHBG)

D. Type of Test:
Quality control materials

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys SHBG 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 SHBG 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 SHBG 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 SHBG CalCheck 5 is a lyophilized product consisting of SHBG in human and equine (horse) 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 hGH CalCheck 5

| Level | Target Value (nmol/L) | Target Range (nmol/L) |
| --- | --- | --- |
| Check 1 | < 5 | - |
| Check 2 | 20 | 10-30 |
| Check 3 | 80 | 70-90 |
| Check 4 | 150 | 130-170 |
| Check 5 | 200 | 180-220 |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Elecsys SHBG CalCheck

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

K031698

3. Comparison with predicate:

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| Characteristic | Elecsys SHBG CalCheck 5 (New Device) | Elecsys SHBG CalCheck (Predicate Device) |
| --- | --- | --- |
| Similarities | | |
| Intended Use/Indications for use | Same | For use in the verification of the calibration established by the Elecsys SHBG regent on Elecsys analyzers. |
| Format | Same | Lyophilized |
| Matrix | Same | Human serum/Horse serum matrix |
| 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 |
| Reconstituted Stability | Same | 20-25 °C, 4 hours |
| Differences | | |
| Levels | 5 | 3 |
| Assay Measuring Range | 0.800– 200 nmol/L | 0.350 - 200 nmol/L |
| Target Values | Check 1: < 5 nmol/L
Check 2: 20 nmol/L
Check 3: 80 nmol/L
Check 4: 150 nmol/L
Check 5: 200 nmol/L | Check 1: 20 nmol/L
Check 2: 80 nmol/L
Check 3: 150 nmol/L |

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 Elecsys SHBG CalCheck 5 is traceable to the NIBSC 95/560 international standard.

# Value Assignment:

For each Elecsys SHBG CalCheck 5 lot manufactured, the CalChecks are assayed 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 of the respective CalCheck. The assigned range is $\pm 30\%$ of assigned value, in which $10\%$ was allotted for between-analyzer platform tolerance, $10\%$ for stability tolerance and $10\%$ for precision of the assay.

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

For additional analyzers (Elecsys 2010), the same value assignment procedure is performed. The assigned values obtained on 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 SHBG CalCheck 5 were performed on the cobas e 601. Because these studies are not analyzer-dependent, these results, in addition to real-time stability study results, can be applied to the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411 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 18 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 SHBG CalCheck 5 is stable up to 4 hours at $20 - 25^{\circ}\mathrm{C}$.

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

# d. Detection limit:

Not applicable

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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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