ELECSYS PRECICONTROL MULTIANALYTE

K033937 · Roche Diagnostics Corp. · JJY · Jan 7, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033937
• Device Name: ELECSYS PRECICONTROL MULTIANALYTE
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.

Device Story

Elecsys PreciControl MultiAnalyte is a quality control product for Elecsys C-Peptide and Insulin immunoassay systems. It consists of lyophilized synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. Used in clinical laboratory settings to monitor assay performance. Healthcare providers reconstitute the product with distilled water and run it on Elecsys immunoassay analyzers to verify system accuracy and precision. Results help ensure reliability of patient test measurements.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material; analytical performance characteristics such as precision, linearity, and method comparison are not applicable to the control product itself.

Technological Characteristics

Lyophilized multi-analyte control; matrix: buffered equine serum; analytes: synthetic human C-Peptide and recombinant human insulin; format: two levels; reconstitution: 2.0mL distilled water; storage: 2-8°C (unopened), -20°C (reconstituted).

Indications for Use

Indicated for quality control of Elecsys C-Peptide and Elecsys Insulin immunoassays on Elecsys immunoassay systems.

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® PreciControl Cardiac (K032089)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number: k033937
B. Analyte: Multi-analyte Controls assayed and unassayed (C peptide and Insulin)
C. Type of Test: n/a
D. Applicant: Roche Diagnostics Corporation
E. Proprietary and Established Names: Proprietary name – Elecsys PreciControl MultiAnalyte Established name - PreciControl MultiAnalyte
F. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: I
3. Product Code: JJY
4. Panel: 75
G. Intended Use:
1. Intended use(s): The Elecsys PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin Immunoassay systems.
2. Indication(s) for use: n/a
3. Special condition for use statement(s):
4. Special instrument Requirements: This control is for use on the Elecsys immunoassay systems
H. Device Description: The Elecsys PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
I. Substantial Equivalence Information:
1. Predicate device name(s): Elecsys PreciControl Cardiac
2. Predicate K number(s): k032089

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3. Comparison with predicate:

| Device comparisons | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | The Elecsys PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin Immunoassay systems. | PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassay on the Elecsys immunoassay systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 2.0mL distilled water and allow to stand closed for 15 minutes | Same |
| Matrix | Equine serum with added C-Peptide and insulin | Human Serum with added CK-MB, digoxin, myoglobin, and NT-proBNP |
| Stability | Unopened | Unopened |
| | Store at 2-8°C until the expiration date | Store at 2-8°C until the expiration date |
| | Reconstituted | Reconstituted |
| | At -20°C : 1 month On the analyzer 3 hours | At 2-8°C 3 days At -20°C 3 months On the analyzers 3 hours |

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

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A

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b. Linearity/assay reportable range: N/A

c. Traceability (controls, calibrators, or method): The Elecsys PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

d. Detection limit: N/A

e. Analytical specificity N/A:

f. Assay cut-off: N/A

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: N/A

M. Conclusion: Based upon the information provided, I recommend that the Roche Elecsys PreciControl MultiAnalyte be found substantially equivalent with similar defined products based upon 21 CFR 862.1660.