CueSee Hypoxic

K152553 · Eurotrol B.V. · JJS · Apr 22, 2016 · Clinical Chemistry

Device Facts

• Record ID: K152553
• Device Name: CueSee Hypoxic
• Applicant: Eurotrol B.V.
• Product Code: JJS · Clinical Chemistry
• Decision Date: Apr 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

Device Story

CueSee Hypoxic is a stroma-free bovine hemoglobin solution used as a quality control material for blood gas analyzers. It provides oxygen buffering characteristics similar to fresh whole blood. The device is supplied in 2.5 mL clear glass ampules. Clinicians or laboratory technicians introduce the solution into a blood gas analyzer to verify the accuracy of pO2 measurements in the critical low range (15-25 mmHg). The analyzer measures the sample, and the provider compares the result against assigned lot-specific values to assess instrument performance. This process ensures the reliability of patient blood gas testing, helping to prevent diagnostic errors in critical care environments.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed a 31-day shelf life at 2–8 °C and 10-minute open-vial stability. Value assignment was performed using Radiometer ABL 835 Flex, Abbott i-STAT CG4+, and epoc Blood analysis systems.

Technological Characteristics

Stroma-free bovine hemoglobin solution; pre-tonometered with oxygen/nitrogen. Form factor: 2.5 mL clear glass ampules. Storage: 2-8°C. Connectivity: None (manual sample introduction). No preservatives or viscosity adjusters. Traceable to NIST SRM 2658a.

Indications for Use

Indicated for professional use in clinical laboratories and point-of-care settings to monitor the performance of blood gas analyzers specifically for oxygen partial pressure (pO2) in the critical low range (15-25 mmHg).

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® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control (K032453)

Submission Summary (Full Text)

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

A. 510(k) Number:
k152553

B. Purpose for Submission:
New Device

C. Measurand:
Quality control material for blood gases

D. Type of Test:
Not applicable

E. Applicant:
Eurotrol B.V.

F. Proprietary and Established Names:
CueSee Hypoxic

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material (Assayed and Unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJS
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See indications for use statements below

2. Indication(s) for use:

CueSee Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Not applicable

I. Device Description:

CueSee Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely affect electrode measurements. CueSee Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution. CueSee Hypoxic is packed in a carton box containing 5 ampules.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bionostics Roche Blood Gas Electrolyte Metabolite Control

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

k032453

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device k032453 |
| Intended Use | Quality control material for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2). | Same |
| Values | Lot specific | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device k032453 |
| Matrix | Pre-tonometered solution of bovine oxyhemoglobin (O2Hb) of purified stroma-free bovine hemoglobin | Buffered aqueous solution containing electrolytes (Na+, K+, Cl-, Ca++, Mg++), glucose, and lactate. It has been equilibrated with specific levels of CO2, O2, and N2. |
| Analytes used for | pO2 | pH, pCO2, pO2, Ca++, Na+, K+, Cl+, Mg++, Glucose, Lactate |
| Storage temperature | 2–8 °C / 35–46°F | 2–8 °C / 35–46°F until expiration date or 9–25 °C / 35–77°F for up to 9 months. |
| Open vial stability | 10 minutes | For pH/blood gas values measure immediately after opening |
| Shelf life | 31 days at 2–8 °C | 36 months at 2–8 °C or 9 months at 2–25 °C |
| Levels | one level | two levels |

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

CLSI EP25-A; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, Vol 29, No. 20, September 2009.

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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:

| Analyte | Reference Material |
| --- | --- |
| pO2 | NIST SRM:, 2658a |

Stability:

The shelf life testing protocol and acceptance criteria for the CueSee Hypoxic control was reviewed and found to be adequate. The real time stability study shows results up to 31 days when stored at $2 - 8^{\circ}\mathrm{C}$ supporting the shelf life claim of 31 days from date of manufacture when stored at $2 - 8^{\circ}\mathrm{C}$ prior to opening.

The open vial stability testing protocol and acceptance criteria for the CueSee Hypoxic control was reviewed and found to be adequate. The open vial stability study shows results up to 10 minutes after opening supporting the open vial stability claim of 10 minutes.

Value Assignment:

Value assignment protocols and acceptance criteria for the CueSee Hypoxic were reviewed and found to be adequate. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot on

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Radiometer ABL 835 Flex analyzer, Abbott i-STAT CG4+ system, and epoc Blood analysis system. Value assignment is performed for each lot of control. An example of one lot of control is listed below:

| Instrument | Mean (mmHg) | SD (mmHg) | Control range (mmHg) |
| --- | --- | --- | --- |
| Radiometer ABL 835 Flex | 19.2 | 4 | 7.2 - 31.2 |
| Abbott iSTAT CG4+ System | 18 | 4 | 6 - 30 |
| epoc Blood Analysis System | 14.8 | 5 | 0.0 – 29.8 |

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

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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:
Representative control mean and range for the control solution has been provided in the labeling.

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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