VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET

K091225 · Maine Standards Co. · JJY · Jun 25, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091225
• Device Name: VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the guantitative determination of linearity, calibration verification of reportable range in automated, semi automated, and manual chemistry systems. See attached 510k submission for the list of all analytes claimed.

Device Story

VALIDATE® GC1-GC4 Test Sets are human and aqueous-based quality control materials; used to establish relationship between theoretical operation and actual performance of chemistry analyzers. Device consists of multiple levels of solutions with linear relationships among them. Used in clinical laboratory settings by laboratory technicians/personnel to perform calibration verification and linearity checks. Output is a set of values compared against analyzer performance to ensure accuracy and reportable range validity. Benefits include ensuring clinical chemistry systems provide reliable patient results.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time, open bottle) and value assignment protocols were reviewed and found acceptable. Traceability to NIST SRM established for GC1, GC2, and GC4.

Technological Characteristics

Liquid, ready-to-use solutions. GC1, GC3, GC4: human serum matrix; GC2: aqueous matrix. 5 levels per set with linear relationship. Storage: -10 to -20°C (GC1, GC3, GC4) or 2-8°C (GC2). Value assignment via equal part dilutions per CLSI EP6-A.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to verify linearity, calibration, and reportable range of automated, semi-automated, and manual chemistry systems. No specific patient population or contraindications defined.

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 1 Calibration Verification / Linearity Test Set
• VALIDATE® Chem 2 Calibration / Linearity Test Set
• VALIDATE® Chem 3 Calibration Verification / Linearity Test Set
• VALIDATE® Chem 4 Calibration Verification / Linearity Test Set (K012120)
• VALIDATE® Chem 5 Calibration Verification / Linearity Test Set

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k091225

B. Purpose for Submission:
New device

C. Measurand:
VALIDATE GC1 Calibration Verification/Linearity Test Set: Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (CA), Chloride (CL), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Potassium (K), Lactate (LAC), Lithium (LITH), Magnesium (MG), Sodium (NA), Phosphorous (PHOS), Total Protein (TP), Triglycerides (TRIG), and Uric Acid (UA).

VALIDATE GC2 Calibration Verification/Linearity Test Set: Ammonia (NH3), Carbon Dioxide (CO2), Ethanol (ETOH), and Iron (FE).

VALIDATE GC3 Calibration Verification/Linearity Test Set: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Amylase (AMY), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), and Lipase (LIP).

VALIDATE GC4 Calibration Verification/Linearity Test Set: Direct Bilirubin (DBIL) and Total Bilirubin (TBIL).

D. Type of Test:
Control Material

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE GC1 Calibration Verification/Linearity Test Set
VALIDATE GC2 Calibration Verification/Linearity Test Set
VALIDATE GC3 Calibration Verification/Linearity Test Set
VALIDATE GC4 Calibration Verification/Linearity Test Set

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

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JJY, Multi-analyte controls, all kinds (assayed)

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

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

2. Indications(s) for use:
VALIDATE GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Sets are intended 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. See attached Package insert labeling for all analytes claimed.

3. Special conditions for use statement(s):
For In Vitro Diagnostic Use. For prescription use only.
These test sets are not intended for use as routine quality control materials or as calibration materials.

4. Special instrument requirements:
Automated, semi-automated, and manual chemistry systems as specified in the package insert.

I. Device Description:

VALIDATE GC1 Calibration Verification/Linearity Test Set is in a human serum matrix that is compatible with chemistry systems for measuring albumin (ALB), blood urea nitrogen (BUN), calcium (CA), cholesterol (CHOL), chloride (CL), creatinine (CREA), glucose (GLU), potassium (K), lactate (LAC), lithium (LITH), magnesium (MG), sodium (NA), phosphorous (PHOS), total protein (TP), triglycerides (TRIG), and uric acid (UA). This test set includes 5 levels that have a linear relationship. Each bottle contains 4.0 mL of solution.

VALIDATE GC2 Calibration Verification/Linearity Test Set solutions is in an aqueous matrix that is compatible with chemistry systems for measuring carbon dioxide (CO2), ethyl alcohol (ETOH), ammonia (NH3), and Iron (FE). This test set includes 5 levels that have a linear relationship and a base matrix. Each bottle contains 3.0 mL of solution.

VALIDATE GC3 Calibration Verification/Linearity Test Set is in a human serum matrix that is compatible with chemistry systems for measuring alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase (AMY), aspartate aminotransferase (AST), creatine kinase (CK), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LD), and lipase (LIP). This test set includes 5 levels that have a linear relationship and a base matrix. Each bottle contains 3.0 mL of solution.

VALIDATE GC4 Calibration Verification/Linearity Test Set is in a human serum matrix

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that is compatible with chemistry systems for measuring total bilirubin (TBIL) and direct bilirubin (DBIL). This test set includes 5 levels that have a linear relationship and a base matrix. Each bottle contains 3.0 mL of solution.

Each lot of the VALIDATE GC test set is manufactured such that a linear relationship exists among the Levels 1 through 5. Therefore, the actual recovered values are used to calculate the target values. The expected value of the Base Matrix is zero; however, in some instances a non-zero result may be obtained.

VALIDATE GC1, GC3 and GC4 Calibration Verification/Linearity Test Sets contain human source material and include the following warning in the insert: Human source material is considered potentially biohazardous. Material of human origin used in the manufacture of this test set was tested using FDA approved methods and found to be non-reactive for HBsAg and to antibodies to HCV and HIV-1/2. Because no test method can offer complete assurance that infectious agents are absent, these specimens should be handled and treated as potentially infectious.

VALIDATE GC2 Calibration Verification/Linearity Test Set is in an aqueous matrix and contains no human source material.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Predicates for VALIDATE GC1 Calibration Verification/Linearity Test Set: VALIDATE CHEM 1 (k012117), VALIDATE CHEM 3 (k012119) VALIDATE CHEM 6 (k013119), and VALIDATE CHEM 7 (k013265) Calibration Verification Test Sets.

Predicates for VALIDATE GC2 Calibration Verification/Linearity Test Set: VALIDATE CHEM 2 (k012118), and VALIDATE CHEM 7 (k013265) Calibration Verification Test Sets.

Predicates for VALIDATE GC3 Calibration Verification/Linearity Test Set: VALIDATE CHEM 4 test set (k012120).

Predicates for VALIDATE GC4 Calibration Verification/Linearity Test Set: VALIDATE CHEM 4 test set (k012120).

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

k012117, k012118, k012119, k012120, k013119, k013265

3. Comparison with predicate:

Comparison for GC1:

| | VALIDATE
GC1 Calibration
Verification/
Linearity | VALIDATE
CHEM 1
Calibration
Verification | VALIDATE
CHEM 3
Calibration
Verification | VALIDATE
CHEM 6
Calibration
Verification | VALIDATE
CHEM 7
Calibration
Verification |
| --- | --- | --- | --- | --- | --- |

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| | Test Set | Test Set | Test Set | Test Set | Test Set |
| --- | --- | --- | --- | --- | --- |
| 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. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. |
| Analytes | ALB, BUN, CA, CHOL, CL, CREA, GLU, K, LAC, LITH, MG, NA, PHOS, TP, TRIG, UA | BUN, CA, CL, GLU, K, LAC, LITH, MG, NA, PHOS, TRIG, | ALB, CHOL, TP | UA | CREA, ETOH, FE, NH3 |
| Matrix | Human Serum | Aqueous | Human Serum | Aqueous | Aqueous |
| Number of Levels | 5 | 6 including zero | 6 including zero | 6 including zero | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use | Liquid, ready to use | Liquid, ready to use | Liquid, ready to use |
| Packaging | 4.0 mL each level | 5.0 mL each level | 5.0 mL each level | 5.0 mL each level | 5.0 mL each level |
| Storage | -10 to -20°C | 2-8°C | 2-8°C | 2-8°C | 2-8°C |

Comparison for GC2:

| | VALIDATE
GC2 Calibration
Verification/ Linearity
Test Set | VALIDATE
CHEM 2 Calibration
Verification
Test Set | VALIDATE
CHEM 7 Calibration
Verification
Test Set |
| --- | --- | --- | --- |
| 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. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. |
| Analytes | CO2, ETOH, FE, NH3 | BUN, CO2, GLU | CREA, ETOH, FE, NH3 |
| Matrix | Aqueous | Aqueous | Human Serum |
| Number of Levels | 6 including a base matrix | 6 including zero | 6 including zero |

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Comparison for GC3:

| | VALIDATE
GC3 Calibration
Verification/ Linearity
Test Set | VALIDATE
CHEM 4 Calibration
Verification
Test Set |
| --- | --- | --- |
| 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. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. |
| Analytes | ALP, ALT, AMY, AST, CK, GGT, LD, LIP | ALP, ALT, AMY, AST, CK, GGT, LD, LIP, TBIL, DBIL |
| Matrix | Human Serum albumin | Bovine Serum Albumin stabilized with Ethylene Glycol |
| Number of Levels | 6 including a base matrix | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 3.0 mL each level | 5.0 mL each level |
| Storage | -10 to -20°C | -10 to -20°C |

Comparison for GC4:

| | VALIDATE
GC4 Calibration
Verification/ Linearity
Test Set | VALIDATE
CHEM 4 Calibration
Verification
Test Set | VALIDATE
CHEM 5 Calibration
Verification
Test Set |
| --- | --- | --- | --- |
| 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. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems. |
| Analytes | DBIL, TBIL | ALP, ALT, AMY, AST, CK, GGT, LD, LIP, TBIL, DBIL | TBIL and DBIL as part of the TBIL component |
| Matrix | Human serum albumin | Bovine Serum Albumin stabilized with Ethylene Glycol | Bovine Serum Albumin |
| Number of Levels | 6 including a base matrix | 6 including zero | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use | Liquid, ready to use |

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| Packaging | 3.0 mL each level | 5.0 mL each level | 5.0 mL each level |
| --- | --- | --- | --- |
| Storage | -10 to -20°C | -10 to -20°C | -10 to -20°C |

K. Standard/ Guidance Document Referenced (if applicable):
CLSI document 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:
For VALIDATE GC1, GC2, and GC4 Calibration Verification/Linearity Test Sets the sponsor states that solutions are tested during manufacturing with standards traceable to National Institute for Standards and Technology (NIST) Standard Reference Material (SRM), where available. For analytes where NIST materials are not available, primary analytical standards are used.
VALIDATE GC3 Calibration Verification/Linearity Test Set: No traceability claims were made.
Stability:
Real-time, open bottle, stability testing protocols and acceptance criteria were reviewed and found to be acceptable. GC2 is held at 2 to 8°C whereas GC1, GC3 and GC4 were held at -10 to -20°C for up to 13 months (one month beyond the claimed shelf life). Test sets are stable until the expiration date printed on the bottle when stored according to instructions at -10 to -20°C for GC1, GC3, and GC4 and 2 to 8°C for GC2. A maximum of four (4) freeze-thaw cycles are recommended for GC1, GC3, and GC4 and it is recommended not to freeze GC2.
Value Assignment:
Levels 1 and 5 are spiked with the required raw materials and intermediate levels (2-4) are made by following EP6-A by equal part dilutions. For value assignment samples are tested, in triplicate, at three stages of manufacturing: in process (level 1 and 5), secondary (all levels) and final product in bottles (all levels). Each determination must fall within the cited acceptance range. Appropriate controls are run with each determination. The analyzer used for analysis depends on the

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final product configuration. It is recommended that each laboratory establish its own values and acceptable non-linearity.

c. Detection limit:
Not Applicable.

d. Analytical specificity:
Not Applicable.

e. 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):

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.

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