DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D

K093357 · Diamond Diagnostics, Inc. · JIT · Jun 24, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093357
• Device Name: DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na⁺, K⁺, and Cl⁻ electrodes on the Polymeco Poly-Chem, and Randox Daytona instruments having the Medica ISE Module.

Device Story

Diamond Calibrators for Medica ISE Modules are liquid, buffered salt solutions used to calibrate Na⁺, K⁺, and Cl⁻ electrodes on specific clinical chemistry analyzers (Polymeco Poly-Chem, Randox Daytona). Calibrant A (500 mL foil bag) and Calibrant B (125 mL plastic bottle) contain defined concentrations of sodium, potassium, and chloride ions. The device is used in a clinical laboratory setting by trained personnel. The healthcare provider uses the calibrators to establish reference points for the ISE module, ensuring accurate measurement of patient electrolyte samples. The device contains no human or biological materials.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (accelerated) and traceability to NIST standards (919a, 918a) were performed to validate the device.

Technological Characteristics

Buffered solution of electrolytes and preservatives; contains no human or biological materials. Form factor: 500 ml foil bag (Calibrant A) and 125 ml plastic bottle (Calibrant B). Storage: 18-25°C. Standalone chemical calibrator.

Indications for Use

Indicated for in-vitro diagnostic use to provide calibration points for Na⁺, K⁺, and Cl⁻ electrodes on Polymeco Poly-Chem and Randox Daytona instruments equipped with Medica ISE Modules. For prescription use.

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

• Medica ISE Module Calibrators (K070057)

Submission Summary (Full Text)

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

A. 510(k) Number:
k093357

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for Na⁺, K⁺, and Cl⁻

D. Type of Test:
Not applicable

E. Applicant:
Diamond Diagnostics

F. Proprietary and Established Names:
Diamond Calibrators for Medica ISE Modules

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIT | Class II | 21 CFR 862.1150 | Chemistry 75 |

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na⁺, K⁺, and Cl⁻ electrodes on the Polymeco Poly-Chem, and Randox Daytona instruments having the Medica ISE Module.

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3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Poly-Chem analyzer and Randox Daytona analyzer with Medica ISE Module

I. Device Description:

Calibrant A consists of a buffered solution which contains 140 mmol/L Na⁺, 4 mmol/L K⁺, 125 mmol/L Cl⁻ and preservatives. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 500 mL of solution. This device contains no human or biological materials.

Calibrant B consists of a buffered solution which contains 70 mmol/L Na⁺, 8 mmol/L K⁺, 41 mmol/L Cl⁻ and preservatives. It is packaged in a brown plastic bottle with a cap. Each plastic bottle contains 125 mL of solution. This device contains no human or biological materials.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Medica ISE Module Calibrator

2. Predicate 510(k) number(s)

k070057

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device Diamond Calibrators for Medica ISE Module | Predicate Device Medica ISE Module Calibrators (k070057) |
| Indications for Use | For in-vitro diagnostic use to provide calibration points for Na⁺, K⁺, and Cl⁻ electrodes on the instruments having the Medica ISE Module | Same |
| Matrix | Buffered solution of salts and preservatives. Contains NO human or animal materials. | Same |
| Packaging | Calibrant A is contained within a foil bag. Calibrant B is contained within a dark brown plastic bottle. | Same |
| Storage | 18-25°C | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Shelf Life | Calibrant A – Shelf life is 30 months, open vial stability is 30 days;
Calibrant B – Shelf life is 28 months, open vial stability is 1 hour after pipetting into sample cup. | 36 months |

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

Abbreviated 510(k) Submissions for In Vitro Calibrators; Final Guidance for Industry-February 1999

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

Sponsor claims traceability to the following material:

| Analyte | Standard Used for Determination of Analyte Value |
| --- | --- |
| Na, K, | NIST 919a, 918a |
| Cl | NIST 919a |

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Value Assignment

Commercially available salts/chemical constituents are gravimetrically weighed and added to Type 1 deionized water to yield the desired concentrations. To ensure that target values are met, multiple replicates of test samples are measured at the beginning and end of the production run on multiple analyzers. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Samples are then tested against previous lots normalized to either an aqueous standard made with corresponding analyte NIST (National Institute of Standards and Technology) material or a known calibrator.

Stability

Accelerated stability testing protocols and acceptance criteria were described and found to be adequate. Calibrant A has an estimated shelf life of 30 months when stored at 18-25°C. Calibrant B has an estimated shelf life of 28 months when stored in the dark at 18-25°C. On Board stability for Calibrant A is 30 days. On-Board stability for Calibrant B, after pipetting into a sample cup, is 1 hour. Real time stability testing is ongoing.

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:

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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:

An example of the lot specific target values are as follows:

| ISE Module Calibrator | Na+ mmol/L | K+ mmol/L | Cl- mmol/L |
| --- | --- | --- | --- |
| Calibrator A | 140 ± 2.0 | 4.00 ± 0.05 | 125 ± 2.0 |
| Calibrator B | 70 ± 1.5 | 8.0 ± 0.08 | 41 ± 1.5 |

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.