MISSION TRINITY B

K062674 · Diamond Diagnostics, Inc. · JJY · Dec 1, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062674
• Device Name: MISSION TRINITY B
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, PCO2, PO2, Na+, Ca++, Cl-, glucose, lactate, tHb, % O2Hb, % CoHb, % metHb & % HHb on Bayer instrumentation.

Device Story

Mission Trinity B™ Controls are a three-level aqueous quality control material used to monitor the performance of Bayer blood gas, electrolyte, metabolite, and CO-Oximetry analyzers. The solution contains buffers, electrolytes, glucose, lactate, and dyes, equilibrated with CO2, O2, and N2. It is packaged in sealed glass ampules. The control is used by laboratory personnel to verify that the analyzer is operating within established performance ranges. By measuring the control material, the healthcare provider assesses the accuracy and precision of the instrument's analytical results, ensuring reliable diagnostic data for patient care.

Clinical Evidence

No clinical data. Performance verified via bench testing, including accelerated high-temperature stress tests for stability and side-by-side comparative testing against the predicate device on intended instrumentation.

Technological Characteristics

Aqueous solution of buffers, electrolytes, glucose, lactate, and dyes; equilibrated with CO2, O2, and N2. Form factor: 1.8mL glass ampule (heat-sealed, score-break). Storage: 2-8°C or 18-25°C. Contains no human or animal materials. Standalone control material; no software or connectivity.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb, and %HHb on Bayer blood gas, electrolyte, metabolite, and CO-Oximetry analyzers. For in vitro diagnostic 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

• Bayer Rapid QC™Complete

Submission Summary (Full Text)

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

A. 510(k) Number:
k062674

B. Purpose for Submission:
New Device

C. Measurand:
Quality control material for pH, PCO2, PO2, Na+, K+, Ca++, 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 B™ Controls

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Multi-Analyte Controls, All Kinds (Assayed and Unassayed) JJY | Class I | 21 CFR 862.1660 | 75 Clinical Chemistry (CH) |

H. Intended Use:

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

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2. Indication(s) for use:

Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, PCO2, PO2, Na+, Ca++, Cl-, glucose, lactate, tHb, % O2Hb, % CoHb, % metHb & % HHb on Bayer instrumentation.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Bayer 270/800/400 Analyzer Series Instrumentation

I. Device Description:

Mission Trinity B™ Controls are a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. This control material is provided in three (3) distinct levels of pH, pCO2, PO2, Na+, K+, Cl-, Ca++, glucose, lactate, tHb, O2Hb, COHb, metHb, and HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 mL of solution.

J. Substantial Equivalence Information:

| Characteristics | Mission Trinity B (New Device k062674) | Bayer Rapid QC™Complete |
| --- | --- | --- |
| PN | DD-96001, 96002, 96003, 96123 | 108860, 108868, 108869 |
| Contents: Any Level | Aqueous solution of buffers, electrolytes, glucose lactate dyes, equilibrated with CO2, O2and N2. Contains NO human or animal materials. | Aqueous solution of buffers, electrolytes, glucose lactate dyes, equilibrated with CO2, O2and N2. Contains NO human or animal materials. |
| Container | Glass ampule (heat sealed, score break) | Glass ampule (heat sealed, score break) |
| Color | Red/ purple solution | Red/ purple solution |
| Package | 30 X 1.8 mL (instrument only requires a fraction of an mL to make measurement | 30 X 2.5 mL |
| Intended Use | For in-vitro diagnostics use for quality control of pH, Blood Gas analyzers, ISE analyzers, CO-oximeters, and Metabolite Analyzers. | For in-vitro diagnostics use for quality control of pH, Blood Gas analyzers, ISE analyzers, CO-oximeters, and Metabolite Analyzers. |
| Storage/ Shelf Life | 2-8°C (36-months) or 18-25°C 12 - months | 2-8°C (36 months) or 18-25°C (until expiration date) |

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# 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

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

Traceability: The assigned values for the Mission Trinity Control were derived from formulated pilot lots of levels 1, 2, and 3 matching the Bayer Complete (OEM) Controls as close as possible. The bias with the predicate's assay sheet is taken into account. The established ranges are $\pm 10\%$ with some exceptions such as CO-OX fractions. The Mission Trinity Control test pilot lots and Bayer Complete were assayed on the Bayer 855 analyzer for comparison. The results are presented in the table below.

| Analyte | Units | Level 1 | | Level 2 | | Level 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | OEM | Pilot | OEM | Pilot | OEM | Pilot |
| pH | --- | 7.16 | 7.16 | 7.36 | 7.36 | 7.57 | 7.65 |
| pCO2 | mmHg | 73 | 61 | 43 | 42 | 23 | 23.4 |
| pO2 | mmHg | 142 | 156 | 99 | 106 | 29 | 17 |
| Na+ | mmol/L | 112 | 116 | 134 | 139 | 157 | 154 |
| K+ | mmol/L | 3.14 | 2.73 | 4.87 | 4.15 | 6.96 | 6.32 |
| Cl- | mmol/L | 72 | 74 | 96 | 93 | 120 | 112 |
| iCa | mmol/L | 1.61 | 1.4 | 1.16 | 0.85 | 0.76 | 0.34 |
| tHb | g/dL | 16 | 18.6 | 12.7 | 11.9 | 7.8 | 6.7 |
| O2Hb | % | 77.5 | 81.2 | 90.4 | 91.1 | 58.5 | 57 |
| COHb | % | 4.4 | 1.6 | 6.3 | 6.6 | 20.9 | 21.5 |
| MetHb | % | 15.5 | 14.3 | 1.5 | 1.4 | 6.3 | 5.4 |
| HHb | % | 2.6 | 2.9 | 1.8 | 1.0 | 15.4 | 16 |
| Glucose | mg/dL | 206 | 200 | 99 | 107 | 50 | 55 |
| Lactate | mmol/L | 12.3 | 12.3 | 0.91 | 0.90 | 3.00 | 3.00 |
| Na+ | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| K+ | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| Cl- | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| iCa | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| tHb | g/dL | 16 | 18.6 | 12.7 | 11.9 | 7.8 | 6.7 |
| O2Hb | % | 77.5 | 81.2 | 90.4 | 91.1 | 58.5 | 57 |
| COHb | % | 4.4 | 1.6 | 6.3 | 6.6 | 20.9 | 21.5 |
| MetHb | % | 15.5 | 14.3 | 1.5 | 1.4 | 6.3 | 5.4 |
| HHb | % | 2.6 | 2.9 | 1.8 | 1.0 | 15.4 | 16 |
| Glucose | mg/dL | 206 | 200 | 99 | 107 | 50 | 55 |
| Lactate | mmol/L | 12.3 | 12.3 | 0.91 | 0.90 | 3.00 | 3.00 |

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Stability: The sponsor performed an accelerated stability study of the Mission Trinity B Controls stored refrigerated at (2-8°C) for 36-months, and also 12-months stability when stored at room temperature (18-25°C). Real time stability studies are on-going.

The sponsor’s stability study demonstrated that the Mission Trinity Controls are stable up to 12 months when stored at 18-25°C or 36 months when stored at 2-8°C.

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):

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4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected mean and ranges are provided in the labeling. The sponsor recommends in the labeling that the expected ranges are provided as a guide in evaluating analyzer performance and that each laboratory should establish its own acceptance criteria for the control materials.

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 equivalent decision.

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