MISSION COMPLETE

K060206 · Diamond Diagnostics, Inc. · JJY · Mar 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060206
• Device Name: MISSION COMPLETE
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Mission Complete™ Linearity Controls are intended to be used for confirming the calibration and linearity of instruments measuring pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, and Lactate. For Prescription Use only

Device Story

Mission Complete™ Linearity Controls are assayed quality control materials used to verify instrument calibration and linearity for blood gas, electrolyte, and metabolite analyzers. The device consists of aqueous solutions provided in 5 levels to cover clinically relevant analyte ranges. It is packaged in sealed glass ampules (1.8 ml each). The product is intended for professional use in clinical settings where blood gas and chemistry analyzers are operated. It is not a calibrator. Healthcare providers use the control results to ensure instrument accuracy and performance within established specifications. The material is stable for 3 years when stored at 2-8 °C.

Clinical Evidence

No clinical data. Bench testing only. Stability substantiated via accelerated aging studies showing concentration changes within +/- 5% over 36 months. Analyte concentrations are traceable to NIST standards (NIST 919a, 918a, 915a, 917b) and Pointe Lactate standards.

Technological Characteristics

Buffered aqueous solution containing electrolytes, glucose, and lactate; equilibrated with CO2, O2, and N2. No human or animal-derived materials. Form factor: 1.8 mL sealed glass ampules. Intended for one-time use. Storage: 2° - 8°C. Shelf life: 3 years.

Indications for Use

Indicated for use as quality control material to confirm calibration and linearity of blood gas, electrolyte, and metabolite instruments measuring pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate.

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

• RNA Medical CVC 123

Submission Summary (Full Text)

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

A. 510(k) Number:
k060206

B. Purpose for Submission:
Clearance to market quality control material

C. Measurand:
Quality control material for pH, pCO₂, pO₂, Na⁺, K⁺, Cl⁻, Ca²⁺, glucose, and lactate.

D. Type of Test:
Quality control material

E. Applicant:
Diamond Diagnostics

F. Proprietary and Established Names:
Mission Complete™ Linearity Controls

G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I (reserved)
3. Product code:
JJY
4. Panel:
(75) Chemistry

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H. Intended Use:

1. Intended use(s):

Please see indications for use.

2. Indication(s) for use:

Mission Complete™ Linearity Controls are intended to be used for confirming the calibration and linearity of instruments measuring pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, and Lactate.

3. Special conditions for use statement(s):

For Prescription Use only

4. Special instrument requirements:

The labeling states the specific instruments for use with this device.

I. Device Description:

The Mission Complete™ Linearity Control are assayed materials used for confirming the calibration and linearity of blood gas, electrolyte, and metabolite instruments measuring pH, pCO₂, pO₂, Na⁺,K⁺, Cl⁻, Ca²⁺, glucose, and lactate. The device is intended to confirm the calibration of an instrument. The device is not intended for use as a calibrator.

The control material is provided in 5 levels of control chosen to cover the clinically relevant range of each analyte. The control material is packaged in sealed glass ampules. Each ampule contains 1.8 ml of solution. The material is stable for 3 years if stored at 2-8 °C.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Blood gas, electrolyte, lactate, and BUN controls

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

k943754

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Common Analytes | pH, pCO2, pO2, Na+,K+, Cl-, Ca+2, glucose, and lactate | Same |
| Storage | 2-8 °C | Same |
| Reagent format | Aqueous liquid | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Lithium | Not present | Present |
| Levels of Control | 5 | 3 |
| BUN | Not present | Present |
| Shelf Life | 3 years | 1.5 years |

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

None referenced.

L. Test Principle:

Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable of a device of this type.

b. Linearity/assay reportable range:

Not applicable of a device of this type.

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

The control material is prepared gravimetrically from analytic grade material. $\mathrm{CO}_{2}$ and $\mathrm{O}_{2}$ are introduced into the solute by bubbling. Confirmation of the analyte concentration is obtained through comparison to a NIST standard. The company uses NIST 919a as reference material for $\mathrm{Na}^{+}$ and $\mathrm{Cl}^{-}$ . For $\mathrm{K}^{+}$ ,

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the company compares to NIST 918a. For $\mathrm{Ca}^{+2}$, the company compares to NIST 915a. The company confirms the glucose concentration of their controls by comparison to NIST 917b. The concentration of lactate is obtained via comparison to a Pointe Lactate standard.

The company substantiated their claim for a 3 year shelf life via accelerated aging studies. Samples demonstrated a change in concentration of less than $+/-5\%$, the acceptance criteria used by the company. The data supplied by the company supports the 36 month shelf life if stored at $2-8^{\circ}\mathrm{C}$.

d. Detection limit:

Not applicable of a device of this type.

e. Analytical specificity:

Not applicable of a device of this type.

f. Assay cut-off:

Not applicable of a device of this type.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable of a device of this type.

b. Matrix comparison:

Not applicable of a device of this type.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable of a device of this type.

b. Clinical specificity:

Not applicable of a device of this type.

c. Other clinical supportive data (when a. and b. are not applicable):

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Not applicable of a device of this type.

4. Clinical cut-off:
Not applicable of a device of this type.

5. Expected values/Reference range:
Not applicable of a device of this type.

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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