VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT

K113524 · Maine Standards Co. · JJX · Jan 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113524
• Device Name: VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: total 25 (OH) Vitamin D (VIT D).

Device Story

VALIDATE® VIT D Calibration Verification / Linearity Test Kit consists of purified chemicals in human serum base; provided in multiple levels to establish relationship between theoretical and actual performance of total 25 (OH) Vitamin D. Used in clinical laboratories to verify instrument calibration, reportable range, and linear response. Healthcare providers use output to ensure accuracy of patient test results; helps maintain quality control standards for diagnostic assays.

Clinical Evidence

No clinical data. Bench testing only. Performance established via linear regression techniques on the DiaSorin Liaison analyzer to confirm target values and equal distance between levels per CLSI EP06-A.

Technological Characteristics

Human serum base matrix; purified chemicals; five levels plus base matrix; liquid, ready-to-use; storage -10 to -25°C. Complies with CLSI EP06-A for linearity evaluation. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of total 25(OH) Vitamin D assays on the DiaSorin Liaison Analyzer.

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

• VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit

Submission Summary (Full Text)

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

A. 510(k) Number:
k113524

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for total 25 (OH) vitamin D (VIT D)

D. Type of Test:
Not applicable

E. Applicant:
Maine Standards Company, LLC

F. Proprietary and Established Names:
VALIDATE® VIT D Calibration Verification / Linearity Test Kit

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

H. Intended Use:

1. Intended use(s):
VALIDATE VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: total 25(OH) Vitamin D (VIT D). The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling.

2. Indication(s) for use:

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Refer to intended use above

3. Special conditions for use statement(s):

For in vitro diagnostic use

For prescription use

4. Special instrument requirements:

DiaSorin Liaison® Analyzer

I. Device Description:

Each VALIDATE® VIT D Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes. The test kit assists in the documentation of linearity, calibration verification and verification of linear range. The solutions will also provide assistance when troubleshooting instrument systems, reagent problems and calibration anomalies.

| Analyte | Units | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 |
| --- | --- | --- | --- | --- | --- | --- |
| 25(OH) Vit D | ng/mL | 5 | 39 | 73 | 106 | 140 |

Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device name(s):

VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit

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

k013119

3. Comparison with predicate

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| | Candidate Device
VALIDATE VIT D Calibration Verification / Linearity Test Kit | Predicate (K013119)
VALIDATE Chem 6 Calibration Verification / Linearity Test Kit |
| --- | --- | --- |
| Indications for Use | Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the given analyte. | Same |
| Analytes | 25 (OH) vitamin D (VIT D) | Uric acid |
| Matrix | Human serum base | Aqueous |
| Number of levels per set | 6 including a base matrix | 6 including zero |
| Preparation | Liquid, ready to use | Same |
| Fill volume | 1.5 mL each level | 5.0 mL each level |
| Storage and stability | Until expiration at -10 to -25 °C | Until expiration at 2 to 8 °C |

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

CLSI EP06-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):

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Traceability

Not applicable

Value Assignment

VIT D Calibration Verification / Linearity Test Kits are manufactured such that a linear relationship exists among Levels 1 through 5 and to provide an equal distance between Levels 1 to 5; Level 1 being the lowest concentration and Level 5 being the highest. A base matrix containing an analyte value of zero is also provided with the kit. The base matrix can be used to make dilutions of Level 1 to obtain a result lower than Level 1, if needed. The dilution scheme is achieved by calculating the delta between two consecutive levels (2, 3) and applying it to subsequent levels. Additionally, using recovered values for Levels 1 and 5 using a percentage calculation can give the required levels (CLSI EP06 Appendix A).

Target values for the linearity set were determined using the 25-Hydroxyvitamin D (25-OH-D) assay on the DiaSorin Liaison analyzer. Actual recovered values were used to calculate target values for each level of the linearity set using a linear regression technique. Appropriate equal distance values were entered as the 'x' values and recovered values from the levels were used as 'y' values to calculate a regression equation. The resulting 'y' values were used as target values for each of the five levels. Expected target values may change depending on instrumentation, methodology, and assay temperature. Typical value ranges are provided in the package insert. Typical value ranges for each level of the linearity set are summarized in the table below.

| Analyte | Units | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 |
| --- | --- | --- | --- | --- | --- | --- |
| 25(OH) Vit D | ng/mL | 5 | 39 | 73 | 106 | 140 |

Stability

Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Closed vial stability of the VALIDATE VIT D Calibration Verification / Linearity Test Kit was determined using real-time open vial studies as a worst case scenario and is on-going. The sponsor recommended storage temperature is -10 to -25°C.

d. Detection limit:

Not applicable

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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
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 typical values are provided in the package insert.

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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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