AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

K100718 · Aalto Scientific, Ltd. · JJY · Sep 3, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100718
• Device Name: AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is “For In Vitro Diagnostic Use Only.”

Device Story

Audit MicroCV Ammonia/Ethanol Linearity Set; protein (bovine)-based aqueous serum substitute; five levels (A-E) with linear concentration relationships. Used in clinical laboratories to verify calibration, linear operating range, and reportable range of ammonia and ethanol assays on Hitachi 911 analyzers. Levels A-E prepared via linear dilution; target values assigned via repeat analysis on Hitachi 911 using standardized ammonia and ethanol reagents. Healthcare providers use output to confirm analyzer performance and detect systematic analytical deviations; ensures accuracy of patient serum sample testing.

Clinical Evidence

No clinical data. Bench testing only. Linearity established per NCCLS EP6-A. Stability (closed vial 2 years, open vial 2 days) validated via accelerated and real-time studies. Traceability established to Pointe Scientific and Diagnostics Chemical Limited standards.

Technological Characteristics

Protein-based (bovine) serum matrix; liquid form; 5 levels per set; 2 analytes (Ammonia, Ethanol). Storage: 2-8°C. Open-vial stability: 2 days at 2-8°C. Shelf life: 2 years at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient serum samples for the detection of systematic analytical deviations in laboratory testing procedures for Ammonia and Ethanol. Intended for use with quantitative assays on specified 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

• Document® Ammonia/Ethanol Calibration Verification Rest Set (k944338)

Submission Summary (Full Text)

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

A. 510(k) Number:
k100718

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for ammonia and ethanol

D. Type of Test:
Assayed and Unassayed Quality Control Materials

E. Applicant:
Aalto Scientific, Limited

F. Proprietary and Established Names:
Audit MicroCV Ammonia/Ethanol Linearity Set

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 862.1660 | Clinical Chemistry |

H. Intended Use:

1. Intended use(s):
Refer to indications for use below

2. Indication(s) for use:
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear

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relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is “For In Vitro Diagnostic Use Only.”

3. Special conditions for use statement(s):

For in vitro diagnostic use

For prescription use

4. Special instrument requirements:

For use with Audit MicroCV Ammonia/Ethanol Linearity Set on the Hitachi 911 analyzer.

I. Device Description:

The Audit MicroCV Ammonia/Ethanol Linearity Set is a protein (bovine) based, aqueous calibration verification material containing five levels (Levels A through E) of ammonia and ethanol. The set is used to confirm proper calibration, linear operating range, and reportable range of the measured analytes. Level A contains ammonia and ethanol concentrations near the lower limit level and Level E contains ammonia and ethanol concentrations near the upper limit level of chemistry analyzers. Levels B-D are related by linear dilution of Level A and Level E.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Document® Ammonia/Ethanol Calibration Verification Rest Set

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

k944338

3. Comparison with predicate

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| | Candidate Device | Predicate (k944338) |
| --- | --- | --- |
| Indications for Use | The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is “For In Vitro Diagnostic Use Only.” | Same |
| Analytes | Ammonia and Ethanol | Same |
| Matrix | Aqueous | Same |
| Number of levels per set | 5 | Same |
| Fill volume | 2.0 mL | 4.0 mL |
| Target Ranges | Ammonia: 20 to 744 μM
Ethanol: 1.6 to 704 mg/dL | Ammonia: 0 to 1000 μM
Ethanol: 0 to 400 mg/dL |
| Storage and stability | 2 days at 2 to 8°C (Opened vial)
2 years at 2 to 8°C (Closed vial) | Same |

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

NCCLS EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

# L. Test Principle:

Not applicable

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

The Audit MicroCV Ammonia/Ethanol Linearity Set is prepared such that a linear relationship exists among all five levels (Levels A through E). Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B-D are related by linear dilution of Level A and Level E using dilution schemes based on guidelines provided by NCCLS EP6-A.

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

Traceability

The sponsor claims traceability of the ammonia and ethanol used in this linearity set to Pointe Scientific Ammonia Standard and Diagnostics Chemical Limited Ethanol Standard, respectively.

Value Assignment

Expected values for ammonia and ethanol were determined by repeat analyses on the Hitachi 911 chemistry analyzer with one set of Pointe Scientific Ammonia Standard and one set of Diagnostics Chemical Limited Ethanol Standard. Both analytes are cleared for use on the Hitachi 911 chemistry analyzer (Ammonia (k864706) and Ethanol (k993920)). Ammonia and Ethanol were measured 10 times and the mean values were used to assign target ammonia and ethanol concentrations values for each of the five linearity set levels. Expected values may change depending on lot, instrumentation, methodology, and assay temperature. Lot-specific expected value ranges are provided in the package insert. Expected value ranges for each level of the linearity set are summarized in the table below.

| Analyte | Units | Level A | Level B | Level C | Level D | Level E |
| --- | --- | --- | --- | --- | --- | --- |
| Ammonia | μM | 20-30 | 143-215 | 260-390 | 378-568 | 496-744 |
| Ethanol | mg/dL | 1.6-2.4 | 120-180 | 235-353 | 354-529 | 470-704 |

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# Stability

Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Stability characteristics of the Audit MicroCV Ammonia/Ethanol Linearity Set were determined using an accelerated study to predict closed vial shelf life for each level of the linearity set. A closed vial shelf life of 2 years is expected at the recommended storage temperature (2 to 8°C). Real-time closed vial stability is ongoing. Real-time opened vial stability studies were also performed. Open vial stability of 2 days was demonstrated at the recommended storage temperature of 2 to 8°C. Storage recommendations are provided in the labeling with additional warnings to prevent prolonged storage at room temperature and to not freeze linearity solutions.

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

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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:
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.

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

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