AUDIT MICROCV LIPIDS LINEARITY SET (LOW)

K070223 · Aalto Scientific, Ltd. · JJY · Mar 13, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070223
• Device Name: AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Lipids Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Lipids testing methods as identified in the package insert.

Device Story

Audit™ MicroCV™ Lipids Linearity Set (Low) is a human-based, lyophilized, five-level quality control material containing 6 lipid analytes. It simulates human patient serum to verify/validate the Analytical Measurement Range (AMR) of non-waived lipid testing methods. Levels A-E are prepared via linear dilution. Used in clinical laboratories by technicians/pathologists to monitor precision, detect systematic analytical deviations, perform CLIA-directed calibration verification, and conduct proficiency testing. The healthcare provider compares instrument results against expected values to ensure accurate calibration and reportable range performance. Benefits include improved diagnostic accuracy and regulatory compliance for lipid testing.

Clinical Evidence

No clinical data. Bench testing only. Stability demonstrated via real-time studies (reconstituted) and heat-stress studies (closed bottle, 37°C for 20 days) with acceptance criteria of ±15% deviation. Linearity validated using CLSI EP6-A guidelines; regression analysis required r² ≥ 0.95.

Technological Characteristics

Lyophilized, human-based serum matrix (delipidized). Contains sucrose and sorbitol stabilizers. 5-level set. Storage 2-8°C. Reconstituted stability 24 hours at 2-8°C. Evaluated per CLSI EP6-A for linearity.

Indications for Use

Indicated for use as a five-level quality control material to verify and validate the Analytical Measurement Range for non-waived lipid testing methods (Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglyceride). Used for proficiency testing, CLIA-directed calibration verification, and as unassayed or assayed quality control material for specified analyzer systems.

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

• Audit™ MicroCV™ General Chemistry Set (k042318)

Submission Summary (Full Text)

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

A. 510(k) Number:
k070223

B. Purpose for Submission:
Notification of intent to manufacture and market a new device

C. Measurand:
Quality control material for apolipoprotein AI, apolipoprotein B, cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride

D. Type of Test:
Quality control materials

E. Applicant:
Aalto Scientific LTD

F. Proprietary and Established Names:
Proprietary - Audit™ MicroCV™ Lipids Linearity Set
Established Name – Quality Control Material

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product code:
JJY
4. Panel:

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H. Intended Use:

1. Intended use(s):

See Indications for Use Below

2. Indication(s) for use:

The Audit™ MicroCV™ Lipids Linearity Set (Low) consists of five levels. Each level contains the following analytes: Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglyceride and may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

3. Special conditions for use statement(s):

For Professional Use Only

4. Special instrument requirements:

The labeling provides a chart that lists the target value and the corresponding ranges by analyte and by instrument.

I. Device Description:

The Audit™ MicroCV™ Lipids Linearity Set (Low) is a human based, lyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Lipids methods for the analytes listed. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B – D are related by linear dilution of Level A and Level E.

Each serum, plasma or whole blood donor unit used in the preparation of this product was tested by FDA approved methods and found to be negative for antibodies to HIV and HCV and non-reactive to HBsAg.

J. Substantial Equivalence Information:

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1. Predicate device name(s):

Audit™ MicroCV™ General Chemistry Set

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

k042318

3. Comparison with predicate:

| Characteristics | Audit™ MicroCV™ Lipids Linearity Set (Low) (New Device) | Audit™ MicroCV™ General Chemistry Linearity Set (k042318) |
| --- | --- | --- |
| Intended Use | Audit™ MicroCV™ Lipids Linearity Set (Low) is assayed quality control material consisting of Delipidized Human Serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures. This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in inter-laboratory surveys. In addition, this product may also be used to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations. | Audit™ MicroCV™ General Chemistry Linearity Set is assayed quality control material consisting of human based serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures. This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in inter-laboratory surveys. In addition, this product may also be used to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations. |
| Number of Analytes per vial | 6 | 30 |
| Number of levels per set | 5 | 5 |
| Contents | 5 x 2 mLs | 5 x 5 mLs |
| Matrix | Delipidized Human Serum | Human Based Serum |
| Type of Analytes | Lipids | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Stabilizers | Sucrose | None |

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| Preservatives | Sorbitol | Sorbitol |
| --- | --- | --- |
| Storage | 2 to 8° C
Until expiration date | 2 to 8° C
Until expiration date |
| Reconstituted Stability | 24 hours at 2 to 8° C | 24 hours at 2 to 8° C |

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

CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach

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 base matrix is delipidized human serum albumin and bovine serum albumin. This is the starting matrix for building the Low and High Pools. Extracts of cholesterol and triglycerides, serum extracts of HDL cholesterol complex (Apolipoprotein A, Cholesterol) and of LDL cholesterol complex (Apolipoprotein B, Cholesterol, Triglycerides) are added to the high level (Level E). For the Low Pool (Level A), all analytes are adjusted to be within 5% to 10% of the lowest limit of measurability for their corresponding assay. For the High Pool (Level E), all analytes are adjusted to be within 5% to 10% of the highest limit of measurability for their corresponding assay.

Value Assignment: The sponsor states that each analyte is to be analyzed a total of 30 times and the mean of the measurements is used as the target concentration. Once a target concentration is established for Levels A – E, these concentrations are plotted on the y-axis vs levels 1 – 5 on the x-axis. If the r² regression line is ≥ 0.95 the relationship between the levels is accepted as linear.

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Opened Bottle Stability: The sponsor recommends that the reconstituted product be stored at 2-8°C and used within 24 hours of reconstitution. Stability at 2-8°C was demonstrated by real time studies. All analytes satisfied the sponsor’s acceptance criteria of ± 15% deviation from analyte concentration at day 0.

Closed Bottle Stability (Shelf Life): The sponsor’s shelf life stability claim is two years from date of manufacture. All analytes were heat stressed at 37°C for 20 days to predict two year stability when stored at 2-8°C. The percent loss is determined in comparison to Day Zero values and the product is considered stable when the loss reported is ≤ 15% loss or gain. All analytes satisfied the sponsor’s acceptance criteria at 20 days of testing verifying the closed bottle stability claim. Real time studies are ongoing.

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:

A table is provided in the labeling that lists the target value and the corresponding ranges by analyte and by instrument.

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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