ELECSYS CA 19-9 CALCHECK

K051185 · Roche Diagnostics Corp. · JJY · Jul 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051185
• Device Name: ELECSYS CA 19-9 CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys® CA 19-9 CalCheck™ is a lyophilized quality control product used to verify calibration of CA 19-9 reagent on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. Product consists of CA 19-9 analyte spiked into buffered human serum matrix. User reconstitutes lyophilized material with distilled or deionized water, allows to stand, and mixes gently before use on analyzer. Device provides verification of calibration performance for clinical laboratory immunoassay testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and reconstituted) confirmed the product meets acceptance criteria (90%-110% of reference value). Value assignment was performed using multiple Elecsys® analyzer platforms.

Technological Characteristics

Lyophilized human serum matrix with spiked CA 19-9 analyte. Three concentration levels. Reconstitution required with 1.0 mL distilled/deionized water. Storage: 2-8°C unopened; 20-25°C for 4 hours post-reconstitution.

Indications for Use

Indicated for use as a quality control material to verify calibration of the Elecsys CA 19-9 reagent on specified Roche 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® C-Peptide CalCheck™ (k040157)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k051185

B. Purpose for Submission:
New device

C. Measurand:
Quality Control Material (assayed for CA 19-9)

D. Type of Test:
Calibration Verification Material for CA 19-9

E. Applicant:
Roche Diagnostics Corp.

F. Proprietary and Established Names:
Elecsys® CA 19-9 CalCheck™

G. 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

H. Intended Use:
1. Intended use:
Elecsys® CA 19-9 Cal Check™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR E170 immunoassay analyzers.
2. Indications for use:
Same as intended use.
3. Special conditions for use statement(s):
None.
4. Special instrument requirements:
Elecsys® 1010, 2010 and MODULAR ANALYTICS E170

I. Device Description:
The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentrations.

J. Substantial Equivalence Information:
1. Predicate device name:
Elecsys® C-Peptide CalCheck™
2. Predicate 510(k) number:
k040157
3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Characteristic | Elecsys CA 19-9 CalCheck | Predicate device Elecsys C-Peptide CalCheck |
| Intended Use | Elecsys® CA 19-9 Cal Check™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR E170 immunoassay analyzers | 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. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 1.0 mL distilled or deionized water and allow standing closed for 15 minutes, then mixing gently. | same |
| Stability | Unopened: Store at 2 - 8°C until expiration date Reconstituted: 20 - 25°C: 4 hours | same |
| Differences | | |
| --- | --- | --- |
| Characteristic | Elecsys CA 19-9 CalCheck | Predicate device Elecsys C-Peptide CalCheck |
| Matrix | Human serum with added human CA 19-9 | Buffered horse serum with added C-Peptide |

K. Standard/Guidance Document Referenced (if applicable):
None 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: - There is no reference material for CA 19-9. The values for the CA 19-9 master calibrators are calibrated against Enzymun Test CA 19-9.

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Values are assigned using four Elecsys® MODULAR ANALYTICS E170 Immunoassay Analyzers, four ELECSYS® 2010 Immunoassay Analyzers and four ELECSYS® 1010 Immunoassay Analyzers. Two independent series of analyses are performed on each instrument. Each sample is tested in duplicate. The target value is then calculated as the median of the determined values. Approximate target values are found in the following table. Lot-specific target values may differ slightly after value assignment.

| CA 19-9 CalCheck™ Level | CA 19-9 Target Values IU/mL |
| --- | --- |
| Check 1 (low) | <5 |
| Check 2 (medium) | 179 |
| Check 3 (high) | 676 |

Stability: Two studies were performed in order to verify the stability claims for the Elecsys® CA 19-9 CalCheck™.

| Stability | Unopened | Reconstituted |
| --- | --- | --- |
| CA 19-9 CalCheck™ | Store at 2 - 8°C until expiration date | 20 – 25°C: 4 hrs |

Study 1: Accelerated Stability. The CA 19-9 CalCheck™ on-test material was stored at 35°C for 3 weeks. At the end of three weeks, it was analyzed in duplicate with a reference material (master calibrators stored at 4-8°C). The product met the acceptance criterion (90%-110% of the reference value). The sponsor will test for real-time stability.

Study 2: Reconstituted Material: Stability of the reconstituted product and reconstituted reference material are tested in duplicate. The product is reconstituted, stored for four hours at 25°C. The reference is a freshly reconstituted set of CA 19-9 CalCheck materials. The product met the stated acceptance criterion (90%-110% of the reference value) to support the stability claim of 4 hours at 20-25°C.

Expected Values: Representative Assigned Values of One Lot of Product

| Level | Value | Range | Unit |
| --- | --- | --- | --- |
| Check 1 | >5 | <5 | U/Ml |
| Check 2 | 158 | 125-191 | U/mL |
| Check 3 | 617 | 487-747 | U/mL |

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:
See section 1c which describes the expected values for the product.

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 substantial equivalence decision.