COBAS INTEGRA CERULOPLASMIN

K062379 · Roche Diagnostics Corp. · JJY · Jan 31, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062379
• Device Name: COBAS INTEGRA CERULOPLASMIN
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Device Story

Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) functions as a quality control material for clinical chemistry assays. The device consists of lyophilized human serum with biological origin material. It is intended for use by laboratory professionals to monitor the accuracy and precision of quantitative methods specified in the product value sheet. The user reconstitutes the lyophilized material with distilled water before use. By running the control alongside patient samples, clinicians verify the performance of their analytical systems, ensuring reliable diagnostic results for patient testing.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Target values assigned via internal laboratory testing on COBAS Integra and Roche Hitachi systems.

Technological Characteristics

Lyophilized human serum-based control; 1.0 mL fill volume. Analyte concentrations at normal and pathological thresholds. Traceable to Institute for Reference Methods and Materials (IRMM). Storage: 2-8°C (unopened). Reconstituted stability: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -15 to -25°C.

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and precision of quantitative laboratory methods for prealbumin and ceruloplasmin analysis.

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

• Precinorm PUC (K040280)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k062379

B. Purpose for Submission:
New device

C. Measurand:
Assayed control for prealbumin and ceruloplasmin assays.

D. Type of Test:
Not applicable.

E. Applicant:
Roche Diagnostics Corp.

F. Proprietary and Established Names:
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC)

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I | 21 CFR 862.1660 | Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

2. Indication(s) for use:
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
COBAS INTEGRA and Roche/Hitachi family of analyzers.

I. Device Description:
The Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is a lyophilized control based on human serum. The adjusted concentrations of the control components are usually in the normal range or at the normal/pathological threshold. Each Precinorm/Precipath PC Control Set contains 3 bottles of controls (a 1.0 ml fill volume per bottle) at Levels I, and II. Individual donors units were tested by FDA approved methods for HBsAg, HCV and HIV and found to be nonreactive.

J. Substantial Equivalence Information:
| Predicate | K040280 Precinorm PUC |
| --- | --- |
| Describe the item being compared | |
| Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. | |

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| Similarities | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Intended Use | Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet | Precinorm PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet |
| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Matrix | Human serum based | Buffered aqueous solution |
| Format | Lyophilized | Liquid, ready to use |
| Handling | Reconstitute with exactly 1.0 mL of distilled water and allow to stand closed for 30 minutes to reconstitute, and then mix gently. | Ready to use. |

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

| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft | OIVD | | http://www.fda.gov/cdrh/ode/99.html |

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): The Precinorm/Precipath Control Set products are assayed and traceable to the Institute for Reference Methods and Materials (IRMM). Values are assigned at three internal laboratories using the COBAS Integra and Roche Hitachi c systems. Each laboratory runs at least three independent series of analyses on each instrument for each analyte. Each sample is tested in singleton. The target value is then calculated as the median of the determined values. The following tables list lot-specific target values and ranges.

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| Precinorm PC | Target value
Roche/Hitachi systems | Target Value COBAS
INTEGRA systems |
| --- | --- | --- |
| Ceruloplasmin | 21.7-35.5 mg/dL | 21.3-34.5 mg/dL |
| Prealbumin | 16.9-27.7 mg/dL | 16.6-26.8 mg/dL |
| Precipath | Target value
Roche/Hitachi systems | Target Value COBAS
INTEGRA systems |
| --- | --- | --- |
| Ceruloplasmin | 49.0-80.2 mg/dL | 51.7-84.1 |
| Prealbumin | 39.6-64.8 mg/dL | 40.6-66.4 |

The unopened products are stable for 18 months when stored at 2 to 8 °C. The following table lists the reconstituted products stability:

| Temperature | Stability |
| --- | --- |
| 15 - 25°C | up to 8 hours |
| 2 - 8°C | 2 days |
| -15 to -25°C | 2 weeks, freeze only once |

Protocols and acceptance criteria for stability testing were described and found to be acceptable.

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

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

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

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The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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