AUDIT MICROCV IMMUNOASSAY LINEARITY SET

K062668 · Aalto Scientific, Ltd. · JJY · Oct 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062668
• Device Name: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

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

Device Story

Audit™ MicroCV™ Immunoassay Linearity Set is a lyophilized, five-level quality control material containing 17 analytes in a human and bovine serum albumin matrix. Levels A-E are prepared via linear dilution to span the reportable range of clinical analyzers. Used in clinical laboratories for proficiency testing, CLIA-directed calibration verification, and as assayed/unassayed quality control material. The healthcare provider reconstitutes the material and runs it on specified analyzer systems; results are compared against target values to verify instrument linearity and performance. Benefits include ensuring accurate measurement of immunoassay analytes and compliance with CLIA-88 regulatory requirements.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed reconstituted stability of 5 days at 2-8°C and a shelf life of two years when stored unopened at 2-8°C.

Technological Characteristics

Lyophilized, five-level set; human and bovine serum albumin matrix; contains 17 analytes and preservatives. Levels A-E are equidistant concentrations. Storage at 2-8°C. Reconstituted stability: 5 days at 2-8°C. Intended for use as assayed QC material only for specific instruments listed in package insert.

Indications for Use

Indicated for use as a quality control material to verify and validate the Analytical Measurement Range for non-waived immunoassay testing methods, including Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. Used for proficiency testing and CLIA-directed calibration verification. Can serve as unassayed QC or assayed QC 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 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:
k062668

B. Purpose for Submission:
New device

C. Measurand:
Quality control set for Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12.

D. Type of Test:
Quality control material

E. Applicant:
Aalto Scientific, Ltd.

F. Proprietary and Established Names:
Audit™ MicroCV™ Immunoassay Linearity Set

G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality control material (assayed and unassayed).
2. Classification:
Class I, reserved
3. Product code:
JJY, multi-analyte controls, all kinds (assayed and unassayed)

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4. Panel:

Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Audit™ MicroCV™ Immunosassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: cortisol, digoxin, estradiol, ferritin, folate, free T4, FSH, hCG, LH, progesterone, prolactin, testosterone, total PSA, total T3, total T4, TSH, and vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product 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 prescription use only.

4. Special instrument requirements:

This device may be used as an assayed quality control material only for the instrument system specified in the package insert.

I. Device Description:

The Audit MicroCV Immunoassay Linearity Set is a human and bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analytes and a preservative. Level A is near the lower limit of instruments and Level E is near the upper limit 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 510(k) number(s):
k042318

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| Intended use | Linearity Material or Assayed QC Material (for analyzer specified in package insert only) | Linearity Material or Assayed QC Material (for analyzer specified in package insert only) |
| Number of Levels per set | 5 | 5 |
| Contents | 5 x 5 ml | 5 x 5 ml |
| Form | Lyophilized | Lyophilized |
| Preservative | Yes | Yes |
| Storage | 2 to 8°C | 2 to 8°C |
| Differences | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| Number of Analytes per Vial | 17 | 30 |
| Matrix | Human and bovine Serum Albumin based | Human Based Serum |
| Analytes | Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12 | Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Lactate, |

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| Differences | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| | | Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid |
| Reconstituted Stability | 5 days at 2 to 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:

Not Applicable

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

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable

b. Linearity/assay reportable range:

The Audit™ MicroCV™ Immunoassay Linearity Set is prepared such that the analyte concentrations are equidistant across levels A – E, with Level A containing the lowest concentrations and Level E the highest concentrations. A linearity study was performed for each analyte by measuring all five levels and calculating an R² value and comparing the measured value of each control level to the target value assigned to each level during the value assignment process (see Value Assignment below). The R² value and the measured vs. target values met the sponsor’s acceptance criteria for each analyte.

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

Traceability

The base matrix consists of human serum albumin, bovine serum albumin, and preservatives. The analytes are derived from both human and non-human sources and were obtained from commercial vendors. The low and high level analytes were adjusted to within the desired target range of each assay. The remaining 3 points are dilutions of the low and high levels.

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# Shelf Life Stability

The sponsor’s unopened bottle shelf life stability claim is two years from the date of manufacture. All analytes were placed on heat stress stability in closed bottles at 37°C and tested on day 0 and day 20. The sponsor supplied a Heat Stress Stability Prediction chart that allowed an analyte heat stressed for 17.5 days at 37°C to predict two year stability at 2-8°C. After 20 days at 37°C all analytes met the manufacturer’s acceptance criteria for deviation from day 0. Real time stability studies are on going to support the accelerated studies.

# Reconstituted Stability

The sponsor claims the reconstituted control is stable for 5 days when stored tightly capped at 2-8°C. All analytes were reconstituted on day 0 and stored in tightly capped bottles at 2-8°C for five days. All analytes were tested on day 0 and day 5 and met the manufacturer’s acceptance criteria for deviation from day 0.

# Value Assignment

Each analyte was measured multiple times and the mean value of each analyte was used to establish target values at each level. The target ranges were calculated as ±20% of the target value. These values are only applicable for the instrument specified for each analyte in the Instructions for Use.

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

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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:
Not Applicable

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.