ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

K111996 · Elitechgroup · JJY · Sep 14, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111996
• Device Name: ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
• Applicant: Elitechgroup
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 14, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

ELITech Clinical Systems ISE CONTROL I and ISE CONTROL II are control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO2 on ELITech Clinical Systems Selectra analyzers equipped with ISE module.

Device Story

ELITech Clinical Systems ISE Control I and II are lyophilized human serum-based quality control products. They contain purified biochemicals, therapeutic drugs, preservatives, and stabilizers. Used in clinical laboratory settings to monitor the performance of ELITech Clinical Systems Selectra analyzers equipped with ISE modules for Na, K, Cl, and Total CO2 testing. The controls are reconstituted with distilled/deionized water by laboratory personnel. Healthcare providers use the resulting control measurements to verify the accuracy and precision of the analyzer's performance, ensuring reliable patient test results. The device benefits patients by providing a mechanism to detect analytical errors in clinical chemistry testing.

Clinical Evidence

No clinical data. Bench testing only; performance data demonstrated substantial equivalence to predicate.

Technological Characteristics

Lyophilized human serum; two-level control; requires reconstitution with 5 mL distilled/deionized water. Analyte stability: 7 days at 2-8 °C, 28-30 days at -10 to -20 °C. Class I device (21 CFR 862.1660).

Indications for Use

Indicated for in vitro diagnostic quality control of Na, K, Cl, and Total CO2 measurements on ELITech Clinical Systems Selectra analyzers equipped with an ISE module. Intended for professional laboratory use.

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

• Biorad-lypochek Assayed Chemistry Control Level 1 and Level 2 (k040273)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVISE ONLY TEMPLATE

A. 510(k) Number:
k111996

B. Purpose for Submission:
New device

C. Measurand:
Quality Control Material for the ELITech clinical Systems ISE Na, K, Cl, Total CO₂ on ELITech Clinical Systems Selectra analyzers equipped with ISE module

D. Type of Test:
Not Applicable

E. Applicant:
ELITechGroup

F. Proprietary and Established Names:
ELITech Clinical Systems ISE Control I
ELITech Clinical Systems ISE Control II

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material
2. Classification:
Class I, reserved
3. Product code:
JJY – Multi-Analyte Controls
4. Panel:

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Clinical Chemistry (75)

## H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indications(s) for use:

ELITech Clinical Systems ISE CONTROL I and CONTROL II are control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO₂, on ELITech Clinical Systems Selectra analyzers equipped with ISE Module.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

The ELITech Clinical Systems ISE CONTROL I and CONTROL II are to be used with ELITech Clinical System Selectra analyzers.

## I. Device Description:

ISE Control I and ISE Control II are two level quality control products consisting of lyophilized human serum with added constituents of purified biochemical chemicals, therapeutic drugs, preservatives and stabilizers containing constituent at desired levels.

ISE Control I and ISE Control II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Biorad-lypochek Assayed Chemistry Control Level 1 and Level 2

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

k040273

3. Comparison with predicate:

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| Reagent Similarities and Differences | | |
| --- | --- | --- |
| | Candidate Device
ELITech Clinical Systems ISE
Control I and II
(k111996) | Predicate Device
Biorad Lypochek Assayed
Chemistry Control Level 1 and 2
(k040273) |
| Intended/Indications for Use | The ISE Control I and ISE Control II are control sera of in vitro diagnostic use in quality control of clinical Systems ISE Na, K, Cl, Total Co2 | Same |
| Specimen Matrix | Lyophilized Human serum | Same |
| Levels | Two Levels | Same |
| Handling | Carefully open the vial avoiding the loss of lyophilizate, and pipette in exactly 5 mL of distilled/deionized water.
Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Using a volumetric pipet, reconstitute each vial with 5.0 mL of distilled or deionized water.
Replace the stopper and allow the control to stand for 20 minutes, swirling occasionally. |
| Stability | Prior to reconstitution: when stored at 2-8°C and protected from light, the controls are stable until the expiration date stated on the label.

After reconstitution:
Between 2-8°C for 7 days
Between -20 to -10 °C for 28 days when frozen once

Note: Store control sera tightly capped and protected from light after reconstitution | When stored unopened the product is stable until the expiration date at 2-8°C. Once the control is reconstituted, all analytes are stable for 7 days when stored tightly capped at 2-8°C and 30 days at -10 to -20°C. Once thawed, do not refreeze |

K. Standard/ Guidance Document Referenced (if applicable):
- Stability Testing of In Vitro Diagnostic Reagents - (CEN-13640)
- Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method (NCCLS-C29-A2)
- Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline-Third Addition (CLSI C24-A3)

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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:
Assigned values are traceable to a reference material or a reference method and provided in the table below.

| Components | Test Methods of ELITech Clinical Systems reagents available in the USA | Traceability |
| --- | --- | --- |
| Sodium | ISE Indirect potentiometry | NIST SRM 919b |
| Potassium | ISE Indirect potentiometry | NIST SRM 918b |
| Chloride | ISE Indirect potentiometry | NIST SRM 918b/919b |
| Total CO2 | ISE Indirect potentiometry | NIST SRM 924a |

Stability:
Unlabeled vials are purchased from a contract manufacturer and ELITech labels and kits the vial using their labeling. Real-time and accelerated stability studies for open and closed-vials were performed and all lots met the acceptance criteria. The shelf life is 36 months prior to reconstitution when stored at 2-8°C and 7 days after reconstitution when stored at 2-8°C or 28 days when stored between -20 to -10°C when frozen once.

Value Assignment
The target values and ranges were determined and defined by ELITech on ELITech Clinical Systems Selectra analyzers equipped with ISE module using ELITech Clinical Systems ISE Na, K, Cl and Total CO2 reagents and ISE calibrators. Calibration was performed with ELITech Clinical System ISE Calibrators which is traceable to reference material. The assignment protocol was performed on two different analyzers with 48 measurements in total (2 analyzers, 2 lots, 3 vials and 4 measurements per vial). The results for ISE Control I are as follows:

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| Analyte | Confidence Range | Expected Range |
| --- | --- | --- |
| Chloride | 10% | 92.2-112.6 mEQ /L |
| Potassium | 10% | 3.33-4.07 mEQ /L |
| Sodium | 10% | 128.0-156.5 mEQ /L |
| Total CO_{2} | 20% | 24.8-37.2 mEQ /L |

The results for ISE Control II are as follows:

| Analyte | Confidence Range | Expected Range |
| --- | --- | --- |
| Chloride | 10% | 81.6-99.7 mEQ /L |
| Potassium | 10% | 5.43-6.64 mEQ/L |
| Sodium | 10% | 114.6-140.0 mEQ /L |
| Total CO_{2} | 20% | 17.1-25.7 mEQ /L |

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:

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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

The expected values are provided in the value sheet available in each kit box. The assigned values were defined by ELITech on ELITech Clinical Systems Selectra analyzers equipped with ISE module using ELITech Clinical Systems ISE Na, K, Cl, and Total CO₂ reagents and ISE calibrators.

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 a substantial equivalence decision.

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