MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)

K093384 · Diamond Diagnostics, Inc. · JJY · Mar 10, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093384
• Device Name: MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Mission Trinity R™ Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.

Device Story

Mission Trinity R is an assayed quality control material; consists of buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives; equilibrated with CO₂, O₂, and N₂ gases. Provided in three levels in sealed 1.8 mL glass ampules. Used by laboratory personnel on Radiometer and Ciba-Corning/Bayer blood gas, electrolyte, metabolite, and CO-oximeter analyzers. Functions as a reference standard to monitor instrument precision; healthcare providers compare analyzer results against assigned control values to verify system performance and ensure clinical accuracy of patient diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability (real-time, shelf-life, open-vial, transport) and value assignment protocols were validated. Traceability established using NIST-traceable standards for electrolytes and glucose.

Technological Characteristics

Buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives. Equilibrated with CO₂, O₂, and N₂. Packaged in 1.8 mL sealed glass ampules. Storage at 2-8°C. Non-biological matrix. No electronic or software components.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the precision and performance of blood gas, electrolyte, metabolite, and CO-Oximeter analyzers. No specific patient population is described as the device is a laboratory quality control material.

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 RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (k880447)

Submission Summary (Full Text)

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

A. 510(k) Number:
k093384

B. Purpose for Submission:
New Device

C. Measurand:
Quality Control material for pH, pCO₂, pO₂, Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, lactate, tHb, %COHb, %metHb and %HHb

D. Type of Test:
Not applicable

E. Applicant:
Diamond Diagnostics, Inc.

F. Proprietary and Established Names:
Mission Trinity R (Level 1, 2, 3)

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I | 21 CFR 862.1660 | Chemistry 75 |

H. Intended Use:

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

2. Indication(s) for use:
Mission Trinity R Control is intended to be used as an assayed quality control material for monitoring the precision performance of the following analytes pH, pCO₂, pO₂,

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Na⁺, K⁺, Ca²⁺, Cl⁻, glucose and lactate on blood gas, electrolyte and metabolite analyzers as well as tHb, %O₂Hb, %O₂Sat, %COHb, %MetHb, %O₂Ct & %HHb on CO-oximeter instrumentation.

3. Special conditions for use statement(s):

Prescription use only

4. Special instrument requirements:

Radiometer ABL Blood Gas analyzers and CO-oximeters, Radiometer OSM3 CO-oximeter, Ciba-Corning/Bayer Blood Gas analyzers

I. Device Description:

Trinity R consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO₂, O₂, and N₂. It contains no human or biological materials.

Trinity R is provided in three distinct levels of pH, pCO₂, pO₂, Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, lactate, tHb, %O₂Hb, %HbO₂Sat, %COHb, %MetHb, %O₂Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level). The ampules are single use products.

J. Substantial Equivalence Information:

1. Predicate device name:

RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control

2. Predicate K number:

k880447

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device |
| Characteristics | Mission Trinity R | RA525 (k880447) |
| Intended Use | For in vitro diagnostics use for quality control of pH/Blood Gas analyzers, | Same |

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| | ISE analyzers, Metabolite analyzers and CO-Oximeter instrumentation. | |
| --- | --- | --- |
| Product Type | Assayed Blood Gas Control | Same |
| Matrix | Buffered Aqueous Solution | Same |
| Storage | 2-8°C | Same |
| Color | Red/purple solution | Same |
| Levels | Three | Same |
| Analytes | pH, pCO₂, pO₂, Na⁺, K⁺, Ca++, Cl⁻, glucose, lactate, tHb, %O₂Hb, %COHb, %metHb, %O₂Ct, %O₂Sat and %HHb | Same |
| Instruments | Multiple instruments | Multiple instruments |
| Differences | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device |
| Characteristics | Mission Trinity R | RA 525 (predicate k880447) |
| Preservative | Present | Not present |
| Package | Package 30 x 1.8mL | 30 x 2.5mL |
| Shelf Life | 24 months | 36 months |

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

FDA Guidance for Industry and FDA Staff: Assayed and Unassayed Quality Control Materials

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

Commercially available salts/chemical constituents are gravimetrically weighed and added to deionized water to yield desired concentrations. Controls are tonometered with commercially available gas to yield the desired pH, $\mathrm{pCO_2}$ , $\mathrm{pO_2}$ , levels for each control. Commercially available dyes are also added to create clinically relevant co-oximeter values for each control. Lot to lot variation of the Mission Trinity R controls is determined by testing the new lot vs. the previous lot normalized to either an aqueous standard made with corresponding analyte NIST material or a known calibrator.

| Analyte | Standard Used for Determination of Analyte Value |
| --- | --- |
| Na, K | NIST 919a, 918a |
| Ca | NIST 915a |
| Cl | NIST 919a |
| Glucose | NIST 917b |
| Lactate | Pointe™ Lactate Std |

# Value Assignment

Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for electrolyte, metabolite, and co-oximetry values. Multiple replicates of test samples are run on two analyzers for blood gas and pH values. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using pre-determined intervals. Value assignment is performed for each lot of Mission Trinity R control.

The labeling states that laboratories should establish appropriate acceptance criteria when using this product for its intended use.

# Stability

Real Time, Shelf-Life, Open Vial, and Transport Simulation testing protocols and acceptance criteria were described and found to be adequate. The Mission Trinity R controls are stable until the expiration date of two years printed on the vials when stored at $2 - 8^{\circ}\mathrm{C}$ . The labeling states that for $\mathsf{pH}$ and blood gas values the controls should be analyzed within one minute of opening and for electrolyte measurements the controls should be analyzed within one hour of opening. This device should not be frozen.

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

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

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