HIGH METABOLITE QUALICHECK

K130415 · Radiometer Medical Aps · JJS · Mar 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130415
• Device Name: HIGH METABOLITE QUALICHECK
• Applicant: Radiometer Medical Aps
• Product Code: JJS · Clinical Chemistry
• Decision Date: Mar 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For prescription use only

Device Story

High Metabolite QUALICHECK is an aqueous quality control solution containing biological buffer, salts, metabolites, and preservatives. It is used by laboratory professionals to verify the accuracy and precision of blood gas and metabolite analyzers (e.g., ABL800, ABL77 series). The device is supplied in single-use ampoules. Users measure the control solution on the analyzer; the resulting values are compared against target ranges provided in the product insert to ensure the analyzer is performing within specifications. This process helps maintain the reliability of clinical diagnostic results for patients.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through real-time studies over 25 months at 2-8°C. Value assignment was performed using 72 ampoules per batch measured across validated ABL7xx analyzers to establish target ranges (mean ± 2SD). Traceability to NIST SRM materials was documented for all analytes.

Technological Characteristics

Aqueous solution containing biological buffer, salts, metabolites, and preservatives (Germall II, Kathon). Single-level control. Supplied in 2 mL ampoules. Compatible with ABL800 and ABL77 series analyzers. Storage at 2 °C to 8 °C.

Indications for Use

Indicated for use as an assayed quality control system to evaluate the accuracy and precision of pO2, ctHb, cGlucose, and cLactate measurements on compatible clinical analyzers.

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

• QUALICHECK5+ (k980135)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k130415

B. Purpose for Submission:
New device

C. Measurand:
Quality control material

D. Type of Test:
Not applicable

E. Applicant:
Radiometer Medical ApS

F. Proprietary and Established Names:
High Metabolite QUALICHECK

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

{1}

H. Intended Use:

1. Intended use(s):

Refer to Indications for use below.

2. Indication(s) for use:

This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.

Analytes are: pO2, ctHb, cGlucose and cLactate

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Not applicable

I. Device Description:

The High Metabolite QUALICHECK is a single level quality control system consisting of thirty ampoules per box (each ampoule contains 2mL of solution). The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.

J. Substantial Equivalence Information:

1. Predicate device name(s):

QUALICHECK5+

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

k980135

3. Comparison with predicate:

{2}

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device |
| Indication for Use | This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. | Same |
| Form | Liquid | Same |
| Base matrix | Aqueous solution | Same |
| Blood Gas Measurement | pO2 | Same |
| Oximetry Measurement | ctHb | Same |
| Metabolite Measurement | cGlucose, cLactate | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device |
| Storage | 2°C to 8°C until expiration date | 2°C to 25°C until expiration date, including up to a total of 15 days at 32°C |
| Open Vial Claim | High Metabolite QUALICHECK solutions are light and heat sensitive. Avoid storage in direct sunlight. Use immediately after opening the ampoule | Ampoules should be conditioned for at least five hours at a constant temperature between 18 °C and 32 °C before use. To maintain the reliability of the blood gas parameters, you must use the contents of the ampoule immediately after opening and according to the instructions in the operator's manual for the relevant analyzer. |
| Preservatives | Germall II, Kathon | ProClin 950 |
| Levels | One level | Four levels |

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

Not applicable

{3}

# 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 materials are traceable to the following standard materials:

| Parameter | Unit | Traceable to |
| --- | --- | --- |
| pO2 | mmHg | NIST Standard Reference Material (SRM) gas 2658a and NIST 2659a |
| cGlucose | mmol/L (37°C) | NIST Standard Reference Material (SRM) 917b |
| cLactate | mmol/L (37°C) | L-Lactic Acid Lithium Salt. SIGMA L2250 |
| ctHb | g/dL | NIST SRM (absorbance, wavelength). Hemoglobin-cyanide standard. J.T. Baker (Product No. 3061) |

# Stability

Shelf life study was conducted on one lot of High Metabolite QUALICHECK at temperatures: $32^{\circ}\mathrm{C}$ for 12 days followed by $8^{\circ}\mathrm{C}$ for a total of 25 months. Six replicates at each test point (0, 3, 6, 9, 12, 18, and 25 months) were tested by measurements on an ABL725. To prevent carryover, an additional rinse was performed between each measurement. Real-time stability study protocols and acceptance criteria have been reviewed and found to be adequate. The data indicated that the control solutions are stable for 2 years at $2 - 8^{\circ}\mathrm{C}$ . There is no open-vial (in-use) stability claim since the control can be used only once. The contents should be used immediately after opening.

# Expected Values/Value assignment

The sponsor provided assigned values and control ranges for each analyte on each of

{4}

6 different analyzers. To determine the assigned values and control ranges for the High Metabolite QUALICHECK, six (6) trays of 1000 ampoules are sampled randomly from the High Metabolite QUALICHECK batch. Twelve ampoules are sampled from each of the trays and 72 ampoules are sampled from each batch. The samples were conditioned and shaken at 25°C in a water bath for 6 hours. Measurements are performed on a minimum of 3 validated ABL7xx devices with data collection. Measurement of each parameter is performed alternately on the reference ampoule and the sample ampoule and repeated 12 times on each ABL-7xx for a total of 144 measurements. Target ranges are calculated based on the mean ±2SD.

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):
Not applicable

{5}

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
A representative target value for the control solution is 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.

6