ISE COMPENSATOR

K052193 · Roche Diagnostics · JIT · Oct 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052193
• Device Name: ISE COMPENSATOR
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.

Device Story

ISE Compensator is a ready-to-use liquid calibrator for Ion Selective Electrodes (ISE) on Roche/Hitachi analyzers. It consists of a buffered human serum matrix containing defined concentrations of sodium, potassium, and chloride, plus stabilizers. The device is used by laboratory personnel to calibrate ISE modules on compatible analyzers. It provides a reference point for measuring electrolyte concentrations in patient samples. The human serum matrix is screened for HBsAg, HCV, and HIV. The product is supplied in 1 mL bottles.

Clinical Evidence

No clinical data. Performance was established through bench testing, specifically evaluating value assignment and stability of the calibrator.

Technological Characteristics

Liquid calibrator; buffered human serum matrix; active ingredients: Na+, K+, Cl-. Ready-to-use format. Stability: 2 weeks at 2-8 °C after opening. Designed for use with Roche/Hitachi analyzer ISE modules.

Indications for Use

Indicated for the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers. For prescription use only.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• ISE Compensation Sera (K870379)

Submission Summary (Full Text)

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

A. 510(k) Number:
k052193

B. Purpose for Submission:
New device

C. Measurand:
Calibrator for sodium, potassium, and chloride

D. Type of Test:
Calibrator

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
ISE Compensator

G. Regulatory Information:
1. Regulation section:
21 CFR Section 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibator, Multi-analyte mixture
4. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):

ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.

2. Indication(s) for use:

ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

For use only with Roche/Hitachi analyzers with Ion Selective Electrodes

I. Device Description:

The ISE Compensator is a ready-to-use calibrator. It is composed of a buffered human serum matrix with defined concentrations of sodium, potassium, and chloride, and added stabilizers. It is supplied in 10, 1 mL sized bottles.

The human serum used in the preparation of the ISE Compensator has been screened by FDA approved methods and found to be negative for HBsAg and antibodies to HCV and HIV.

J. Substantial Equivalence Information:

1. Predicate device name(s):

I.S.E. Calibrator/Conditioner

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

k870379

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Same | For use in the calibration of sodium, potassium, and chloride on the Hitachi systems with Ion Selective electrodes |
| Matrix | same | Human serum with K+, Na+, and Cl- |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Format | liquid | Lyophilized |
| Stability | Store unopened at 2-8°C until expiration date.
Once opened, stable for 2 weeks at 2-8°C. | Store unopened at 2-8°C until expiration date.
Once reconstituted, stable for 5 days at 2-8°C, or 5 days at -20°C. |

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

Not Applicable

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

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability: ISE Compensator is traceable to the reference material NIST-SRM909b. The reference method is flame photometry for the sodium and potassium analytes and coulometry for the chloride analyte. The value assignment process takes place using multiple external laboratories and using different Hitachi analyzers with ion selective electrodes. The final value assigned to each analyte is lot specific and is found on the Value Sheet that is provided with the product.

Stability: The shelf-life and open-vial stability of ISE Compensator when stored at 2-8°C have been demonstrated using real time stability data and predetermined acceptance criteria.

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

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

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