VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

K110880 · Maine Standards Company, LLC · JJY · Jul 5, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110880
• Device Name: VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
• Applicant: Maine Standards Company, LLC
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

Device Story

VALIDATE® GC3 is a quality control test kit containing purified chemicals in a human serum albumin base; used to verify linearity, calibration, and reportable range of automated, semi-automated, and manual chemistry systems. Kit consists of five levels of material with known concentrations to establish the relationship between theoretical and actual analyzer performance. Used by laboratory professionals in clinical settings. Output is a comparison of observed versus target values for specific enzymes, allowing clinicians to confirm instrument accuracy and reportable ranges. Benefits include ensuring reliable diagnostic results for patient testing.

Clinical Evidence

No clinical data. Bench testing only. Sponsor provided stability data for up to 8 months and value assignment data for Cholinesterase (CHE) across five levels, demonstrating target recovery within acceptable limits (max 8.0% difference).

Technological Characteristics

Matrix: Human serum albumin. Form: Liquid, ready-to-use. Levels: 5 levels. Analytes: ALP, ALT, AMY, AST, CK, GGT, LD, LIP, CHE. Storage: -10 to -25°C. Standard: NCCLS EP6-A.

Indications for Use

Indicated for in vitro diagnostic use to determine linearity, verify calibration, and verify reportable range for clinical laboratory testing of specified analytes.

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® GC3 Calibration Verification / Linearity Test Kit (k091225)

Submission Summary (Full Text)

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

A. 510(k) Number:
K110880

B. Purpose for Submission:
Modified Device – Adding Cholinesterase (CHE) to a previously cleared device (k091225)

C. Measurand:
Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Amylase (AMY), Aspartate Aminotransferase (AST), Creatine kinase (CK), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD) and Lipase (LIP) and Cholinesterase (CHE)

D. Type of Test:
Quality control material

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE® GC3 Calibration Verification / Linearity Test Kit

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 21 CFR 862.1660 | Chemistry 75 |

H. Intended Use:
1. Intended use(s):
See Indications for Use below

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2. Indication(s) for use:

VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

3. Special conditions for use statement(s):

For In Vitro Diagnostic Use. For prescription use only.

These tests are not intended for use as routine quality materials or as calibration materials.

4. Special instrument requirements:

The validation and stability studies were conducted using Beckman Coulter AU 680 analyzer.

I. Device Description:

Each VALIDATE® GC 3 Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum albumin base. Five levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

Material of human origin used in the manufacture of this test set has been tested using FDA approved methods and found to be non-reactive for HBsAg and antibodies to HCV and HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device
Maine Standards Company, VALIDATE® GC3 Calibration Verification / Linearity Test Kit

2. Predicate K number

k091225

3. Comparison with predicate

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| | New
VALIDATE® GC3
Calibration Verification /
Linearity Test Kit | Predicate
VALIDATE® GC3
Calibration Verification /
Linearity Test Kit |
| --- | --- | --- |
| Intended Use | For in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems. | Same |
| Analytes | ALP, ALT, AMY, AST, CK, GGT, LD, LIP, CHE | ALP, ALT, AMY, AST, CK, GGT, LD, LIP |
| Matrix | Human serum albumin | Same |
| Number of Levels | 6 including a base matrix | Same |
| Preparation | Liquid, ready to use | Same |
| Packaging | 3.0 mL each level | Same |
| Stability | Until expiration | Same |
| Storage | -10 to -25°C | Same |

K. Standard/Guidance Document Referenced (if applicable):
NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. NCCLS document EP6-A [ISBN 1-56238-498-8]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.

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):
Stability

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The sponsor provided protocol, acceptance criteria and summary data for stability for up to 8 months that were reviewed and were accepted to be adequate. The real time stability study is ongoing.

## Traceability:

Same as k091225, there are no traceable materials or methods available for the enzymes in GC3.

## Value assignment

Value assignment for the following analytes in the predicate device have already been cleared under k091225

Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Amylase (AMY), Aspartate Aminotransferase (AST), Creatine kinase (CK), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD) and Lipase (LIP) The data provided by the sponsor indicates that for these analytes, each level is within the claim range and the five levels are linear.

However, since Cholinesterase (CHE) had not been validated previously value assignment for this analyte was provided separately.

The following table lists the Target recovery, the Mean observed, as well as the absolute difference and % difference of the Mean / Target.

| X | Target | Mean | +/- Diff | % Diff |
| --- | --- | --- | --- | --- |
| 1 | 0.97 | 0.94 | 0.03 | 3.1% |
| 2 | 4.37 | 4.44 | 0.07 | 1.6% |
| 3 | 7.78 | 7.74 | 0.04 | 0.5% |
| 4 | 11.18 | 10.74 | 0.44 | 3.9% |
| 5 | 14.58 | 13.41 | 1.17 | 8.0% |

The results provided satisfied the acceptance criteria

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

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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:
Calibration verification/linearity material is manufactured such that equal distance exists between each consecutive level. 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.