AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

K111964 · Aalto Scientific, Ltd. · JJY · Mar 2, 2012 · Clinical Chemistry

Device Facts

• Record ID: K111964
• Device Name: AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is “For In Vitro Diagnostic Use Only”.

Device Story

Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set consists of two sets of five-level lyophilized aqueous buffer vials. Set 1 contains Phosphorous, Urea Nitrogen, Uric Acid; Set 2 contains Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. Levels A-E are related by linear dilution. Used in clinical laboratories to monitor analytical performance of chemistry analyzers; provides target concentration values for quality control. Healthcare providers use these values to establish laboratory-specific means and acceptable ranges for assay monitoring. Benefits include detection of systematic analytical deviations, ensuring accuracy of patient test results.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically stability studies. Reconstituted stability is 72 hours for Set 1 and 10 days for Set 2 at 2-8°C. Shelf life is one year at 2-8°C.

Technological Characteristics

Lyophilized aqueous buffer-based quality control material. Two sets of five levels each. Analytes: Phosphorous, Urea Nitrogen, Uric Acid (Set 1); Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (Set 2). Storage: 2-8°C. Reconstituted stability: 72 hours (Set 1), 10 days (Set 2).

Indications for Use

Indicated for use as assayed quality control material for quantitative chemistry assays on specified analyzers to detect systematic analytical deviations. Not for calibration or standardization. Prescription use only.

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 Linearity Set (k042318)

Submission Summary (Full Text)

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

A. 510(k) Number:
k111964

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for Phosphorous, Urea Nitrogen, Uric Acid (in Set 1); Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (in Set 2).

D. Type of Test:
Not applicable

E. Applicant:
Aalto Scientific, Ltd.

F. Proprietary and Established Names:
Audit MicroCV™ Urine/Fluids Chemistry Linearity Set

G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality Control Material
2. Classification:
Class I, reserved
3. Product code:
JJY, multi-analyte controls, all kinds
4. Panel:

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Clinical Chemistry (75)

## H. Intended Use:

1. Intended use(s):

See indications for use below

2. Indication(s) for use:

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.

The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is “For In Vitro Diagnostic Use Only”.

3. Special conditions for use statement(s):

For prescription use only.

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set should not be used for calibration or standardization of the assays for Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, Phosphorous, Urea Nitrogen, Uric Acid.

4. Special instrument requirements:

Performance was established on the Roche P-Modular analyzer.

## I. Device Description:

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is a two-set ten-vial lyophilized quality control material with Set 1 containing Phosphorous, Urea Nitrogen, Uric Acid and Set 2 containing Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. Each set has five levels (Levels A through E, each level packaged into a 2-ml vial). Level A contains the indicated analytes at concentrations near the lower limit level. Level E contains the indicated analytes at concentrations near the upper

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limit level of chemistry analyzers. Levels B-D are related by linear dilution of Level A and Level E.

All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA cleared/approved tests.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

The Audit™ MicroCV™ General Chemistry Linearity Set

2. Predicate K number(s):

k042318

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device (k042318) |
| Indications for Use | Same | Device is assayed quality control materials intended to detect systematic analytical deviations of laboratory testing procedures. |
| Number of levels per set | Same | 5 |
| Form | Same | Lyophilized |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Device | | Predicate |
| Number of Analytes per vial | Set 1 | Set 2 | 30 |
| | 3 | 10 | |
| Matrix | Aqueous buffer | | Human based Serum |
| Kit Contents | 10 x 2 mL | | 5 x 5 ml |
| Storage | 2 – 8 °C for 12 months | | 2 – 8 °C for 1 year |
| Open Bottle Stability | 3 days for Set 1, 10 days for Set 2 at 2 – 8 °C | | 1 day at 2 – 8 °C |
| Analytes | Phosphorous, Urea Nitrogen, Uric Acid (Set 1); Amylase, Calcium, Glucose, | | Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin |

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| | Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (Set 2). | (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid |
| --- | --- | --- |

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

CLSI EP6-A: evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

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 and value assignment

All components used for the Audit™ Micro CV™ Urine/Fluids Chemistry Linearity Set are obtained from commercial vendors and are inspected in-house.

For each analyte, value assignment for Level A through Level E is performed on one instrument (Roche P-Modular) by one set of reagent. Each analyte was measured 15 times (15 separate vials) and the mean value of each analyte was used to establish target concentration values listed on the insert at each level. The target ranges listed on the package insert were calculated as $\pm 15\%$ of the observed value. The results on Roche P-modular are shown in the table below:

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| Assay/Reagent | Units | A | | B | | C | | D | | E | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | Range | Mean | Range | Mean | Range | Mean | Range | Mean | Range |
| BUN | mg/dL | 34.8 | 29.5-40.0 | 859.9 | 730.9-988.8 | 1663.4 | 1413.9-1912.9 | 2448.5 | 2081.2-2815.8 | 3218.5 | 2735.7-3701.3 |
| Phosphorus | mg/dL | 10.7 | 9.1-12.4 | 60.4 | 51.3-69.4 | 109.0 | 92.7-125.4 | 153.7 | 130.7-176.8 | 200.1 | 170.1-230.1 |
| Uric Acid | mg/dL | 4.41 | 3.70-8.07 | 31.86 | 27.10-36.64 | 54.03 | 45.90-62.14 | 74.06 | 63.00-85.17 | 94.55 | 80.40-108.73 |
| Amylase | mg/dL | 10 | 9-12 | 366 | 311-421 | 714 | 607-821 | 1057 | 899-1216 | 1378 | 1171-1585 |
| Calcium | mg/dL | 2.15 | 1.83-2.47 | 12.22 | 10.39-14.05 | 22.35 | 19.00-25.71 | 32.28 | 27.44-37.12 | 41.56 | 35.33-47.79 |
| Creatinine | mg/dL | 8.23 | 7.00-9.47 | 153.38 | 130.38-176.39 | 297.11 | 252.54-341.68 | 439.86 | 373.88-505.84 | 575.12 | 488.85-661.39 |
| Glucose | mg/dL | 8 | 7-9 | 169 | 144-194 | 329 | 279-378 | 492 | 418-565 | 648 | 551-745 |
| Magnesium | mg/dL | 2.65 | 2.25-3.05 | 7.64 | 6.49-8.78 | 12.47 | 10.60-14.34 | 17.55 | 14.92-20.18 | 22.34 | 18.89-25.69 |
| Sodium | mEq/L | 27.6 | 23.5-31.7 | 72.4 | 61.6-83.3 | 119.2 | 101.4-137.1 | 166.8 | 141.8-191.8 | 211.9 | 180.1-243.7 |
| Potassium | mEq/L | 2.23 | 1.89-2.56 | 25.50 | 21.68-29.33 | 48.72 | 41.41-56.03 | 70.27 | 59.73-80.81 | 87.98 | 74.78-101.17 |
| Chloride | mEq/L | 19.6 | 16.6-22.5 | 67.5 | 57.4-77.7 | 114.0 | 131.1-96.9 | 163.2 | 138.7-187.7 | 210.9 | 179.3-242.6 |
| Microprotein | mg/dL | 8.9 | 7.6-10.3 | 85.1 | 72.3-97.8 | 129.8 | 110.3-149.3 | 153.0 | 130.1-176.0 | 214.5 | 182.3-246.6 |
| Microalbumin | mg/dL | 5.3 | 4.5-6.1 | 9.7 | 8.2-11.1 | 13.7 | 11.7-15.8 | 18.5 | 21.2-15.7 | 24.5 | 20.9-28.2 |

## Stability

Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Accelerated stability was performed to predict the shelf-life and open-vial of the linearity sets. Real-time stability is ongoing to support the stability of the linearity sets. The sponsor states that the shelf-life of the linearity sets are 12 months when stored at $2 - 8^{\circ}\mathrm{C}$. The open-vial stability after reconstitution is 3 days for Set1 and 10 days for Set 2, respectively, at $2 - 8^{\circ}\mathrm{C}$.

## d. Detection limit:

Not applicable

## e. Analytical specificity:

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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

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.