AUDIT MICROCV PROCALCITONIN LINEARITY

K101434 · Aalto Scientific, Ltd. · MJX · Jul 22, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101434
• Device Name: AUDIT MICROCV PROCALCITONIN LINEARITY
• Applicant: Aalto Scientific, Ltd.
• Product Code: MJX · Clinical Chemistry
• Decision Date: Jul 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. 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 for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte. Prescription use only.

Device Story

Audit™ MicroCV™ Procalcitonin Linearity Set is a lyophilized, five-level quality control material containing Procalcitonin in a bovine serum albumin matrix. Designed for use in clinical laboratories to verify calibration, linear operating range, and reportable range of Procalcitonin assays on the Mini-VIDAS BioMerieux instrument. Levels A through E are prepared via linear dilution; Level A represents the lower limit and Level E the upper limit of the instrument's analytical range. Laboratory technicians reconstitute the material with deionized water and process it alongside patient samples. The resulting measurements allow clinicians to monitor assay precision and identify systematic analytical deviations, ensuring the accuracy of Procalcitonin testing used in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Linearity was established by measuring 8 vials per level and performing linear regression (R² > 0.95). Stability was validated via accelerated heat stress testing (37°C for 10 days) and real-time studies, confirming a one-year shelf life and 5-day open-vial stability at 2-8°C, with results within ±15% of Day Zero values.

Technological Characteristics

Lyophilized bovine serum albumin matrix; contains Procalcitonin analyte; 5-level set; preserved with sodium azide; stored at 2-8°C; 5-day open vial stability.

Indications for Use

Indicated for use as an assayed quality control material to monitor precision and detect systematic analytical deviations in laboratory testing procedures for Procalcitonin. Intended for use with the Mini-VIDAS BioMerieux instrument.

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:
k101434

B. Purpose for Submission:
To obtain a substantial equivalence determination for this original application for the Audit™ MicroCV™ Procalcitonin Linearity Set.

C. Measurand:
Procalcitonin.

D. Type of Test:
Calibrators and Controls.

E. Applicant:
Aalto Scientific, Ltd.

F. Proprietary and Established Names:
Audit™ Micro CV™ Procalcitonin Linearity Set
Procalcitonin Linearity Set

G. Regulatory Information:
1. Regulation section:
862.1660 Quality Control Material (assayed and unassayed)
2. Classification:
Class I
3. Product code:
MJX

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4. Panel:

83 - Microbiology

H. Intended Use:

1. Intended use(s):

The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. 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 for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

2. Indication(s) for use:

The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. 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 for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

3. Special conditions for use statement(s):

Prescription use only.

4. Special instrument requirements:

Mini - VIDAS BioMerieux

I. Device Description:

The Audit™ MicroCV™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. 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.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Audit™ MicroCV™ General Chemistry Linearity Set

2. Predicate K number(s):
k042318

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Linear, calibration verification quality control material | Same |
| Number of levels per vial | 5 | Same |
| Contents | 5X 1 mL | Same |
| Matrix | Human based serum | Same |
| Sterile | Yes | Same |
| Form | Lyophilized | Lyophilized |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | |
| Number of analytes per vial | 1 | 30 |
| Type of Analyte | Procalcitonin | General Chemistry |
| Matrix | Bovine Serum Albumin | Human-Based Serum |
| | | |
| Preservatives | Sodium Azide | Sorbitol, Sodium Azide |
| Open vial stability | 5 days at 2-8°C | 7 days at 2 to 8°C except for enzymes and bilirubin, which are 48 hours |

K. Standard/Guidance Document Referenced (if applicable):
Not Applicable.

L. Test Principle:
Laboratories use a stable reference material to verify the accuracy and precision of testing methods and techniques. Audit® MicroCV™ Procalcitonin Linearity Set may

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be used as one would use human serum to verify and validate the test method analytical measurement range.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

a. Precision/Reproducibility:

Not applicable.

b. Linearity/assay reportable range:

Value Assignment was based on measurement of Procalcitonin 8 times (8 separate vials) and the mean value of Procalcitonin was used to establish target concentration values at each level. The target ranges were calculated as $\pm 20\%$ of the target value. The mean concentration values of each level were plotted (concentration value vs. assigned level) and a linear regression values were obtained. If the five-point linear regression $R^2$ value is greater than 0.95 and if the plots are linear, then the product demonstrates linearity.

Representative data from the Procalcitonin Linearity set is shown below for five lots:

| Lot Numbers | 091011 | 091012 | 091013 | 091014 | 091015 |
| --- | --- | --- | --- | --- | --- |
| Levels | Level A | Level B | Level C | Level D | Level E |
| Mean Target Level (ng/mL) | 0.60 | 35.57 | 73.49 | 123.26 | 162.63 |


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

Traceability: Values assigned to the Audit™ Micro CV™ Procalcitonin Linearity Set can be traced to bioMerieux VIDAS Procalcitonin Reagent – 30450-01, Procalcitonin Calibrator – 30450-01, and Procalcitonin Control – 30450-01

The base matrix for building the low and high pools is bovine serum albumin. For the low pool (Level A), Procalcitonin is adjusted to be within 5% to 10% of the lowest limit of measurability for the Procalcitonin assay. For the high pool (Level E), Procalcitonin is adjusted to be within 5% to 10% of the highest limit of measurability for the Procalcitonin assay.

An accelerated “Heat Stress Stability Prediction” stability study was conducted to predict shelf life. Four vials of each level were stressed at 37° C for 10 days to predict one-year stability when stored at 2 – 8° C.

Two pilot lots, Pilot 1, Lot 091011-091015 and Pilot 2, Lot 81164-81168, were produced and tested. For both pilots, Procalcitonin in the stress stability study results were within ± 15% of the Day Zero value. This gives the Procalcitonin Linearity Control one-year shelf life stability.

Accelerated stability studies are supported by an on-going real-time stability studies.

Open vial stability was also performed to determine the viability of the product during the course of normal use. Four vials of each level (A through E) were opened and reconstituted with deionized water. Vials were then closed, stored for 5 days at 2-8 ° C and tested following the same manner as the above stated destructive testing. The percent loss determined in comparison to Day Zero values was < 15% and the product is considered stable.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable

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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:
See section 1b above.

N. Proposed Labeling:
The labeling is sufficient and 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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