ELECSYS C-PEPTIDE CALCHECK

K040157 · Roche Diagnostics Corp. · JJX · Feb 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040157
• Device Name: ELECSYS C-PEPTIDE CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.

Device Story

Elecsys® C-Peptide CalCheck is a lyophilized quality control material consisting of synthetic human C-Peptide in a buffered equine serum matrix. It is used in clinical laboratory settings to verify the calibration of the Elecsys® C-Peptide reagent on Elecsys® immunoassay systems. The product is provided in three concentration levels. Users reconstitute the lyophilized material with distilled water before use. By comparing the measured values of the CalCheck against established target ranges, healthcare providers verify the accuracy and stability of the immunoassay system's calibration, ensuring reliable patient test results for C-Peptide levels.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via modified accelerated testing (35°C for 3 weeks) and reconstituted stability testing (4 hours at 20-25°C). Traceability established against WHO 1st IRR 84/510.

Technological Characteristics

Lyophilized synthetic human C-peptide in buffered equine serum matrix (HEPES and preservatives). Three concentration levels. Traceable to WHO 1st IRR 84/510. Compatible with Elecsys® 1010/2010 and MODULAR ANALYTICS E170 systems.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys® C-Peptide reagent on Elecsys® immunoassay systems to verify established calibration.

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
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k040157

B. Analyte:
C-peptide

C. Type of Test:
Calibration Verification Material for C-peptide

D. Applicant:
Roche Diagnostics Corporation

E. Proprietary and Established Names:
Elecsys® C-Peptide CalCheck

F. Regulatory Information:
1. Regulation section:
21 CFR §862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product Code:
JJX
4. Panel:
75 – Clinical Chemistry

G. Intended Use:
1. Indication(s) for use:
The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.
2. Special condition for use statement(s):
N/A
3. Special instrument Requirements:
Elecsys® 1010/2010 or MODULAR ANALYTICS E170

H. Device Description:
The Elecsys® C-Peptide CalCheck is a lyophilized product consisting of synthetic human C-peptide in a buffered equine serum matrix (HEPES and preservatives). During manufacture the analytes are spiked into the matrix at the desired

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concentration levels: Check 1 ~1 ng/mL, Check 2 ~5 ng/mL, and Check 3 ~30 ng/mL.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Elecsys® SHBG CalCheck

2. Predicate K number(s):
K031698

3. Comparison with predicate:
The intended use, format, preparation of the verifier, instrument systems, and product matrix is the same as the predicate. The analyte is different, and the predicate contains human serum while this product does not.

J. Standard/Guidance Document Referenced (if applicable):
None referenced

K. Test Principle:
Not applicable

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
N/A

b. Linearity/assay reportable range:
N/A

c. Traceability (controls, calibrators, or method):
Values for C-peptide are calibrated against the human pro-insulin WHO reference reagent, 1st IRR, code 84/510 (NIBSC) standard. Values are assigned using four each of the three instruments specified above. Two independent series of analyses are performed on each instrument, and two-fold determinations are made for each sample. The target value is then calculated as the median of the determined values.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

g. Other(stability):
A modified accelerated testing protocol was used to determine stability of the lyophilized product. C-Peptide master calibrators, which have the same composition and target values as the C-Peptide CalCheck, were stored at 35 C for 3 weeks. They were then

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reconstituted and analyzed in duplicate with master calibrators that were stored at -20 C. The product met the acceptance criterion (90%-110% of the value of the frozen calibrators). The sponsor plans on beginning real-time stability testing within a few weeks.

Stability of the reconstituted product was tested by leaving reconstituted product at 20-25 C for five hours after they were prepared and tested in duplicate. The product met the stated acceptance criterion (90%-110% of the initial value) to support the stability claim of 4 hours at 20-25 C.

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: Representative Assigned Values of One Lot of Product

| Level | Value | Range | Unit |
| --- | --- | --- | --- |
| Check 1 | 0.89 | 0.70 - 1.07 | ng/mL |
| Check 2 | 4.28 | 3.38 – 5.18 | ng/mL |
| Check 3 | 26.7 | 21.1 – 32.1 | ng/mL |

M. Conclusion:
I recommend that the Elecsys® C-Peptide CalCheck be found substantially equivalent to the predicate.