VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

K090475 · Maine Standards Co. · JJY · Apr 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090475
• Device Name: VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE CM2 Calibration Verification/Linearity Test Set solutions 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. Each VALIDATE CM2 Calibration Verification/Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-I, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

Device Story

VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of human serum-based solutions containing multiple levels of analytes (TnI, TnT, BNP, NT-proBNP, hsCRP, MPO). Used in clinical laboratories by trained professionals to verify the performance of automated, semi-automated, and manual chemistry analyzers. Device establishes relationship between theoretical operation and actual performance of analytes; confirms linearity and reportable ranges. Not for routine quality control or calibration. Healthcare providers use output to validate analyzer accuracy and ensure reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Value assignment process involves triplicate assays of high/low levels and final bottled product to ensure linear relationship.

Technological Characteristics

Human serum-based matrix; liquid, ready-to-use form factor. Multi-level test set (2 sets of 6 levels). Storage at -10 to -20°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for in vitro diagnostic use in clinical chemistry systems to verify linearity, calibration, and reportable ranges for Troponin-I, Troponin-T, BNP, NT-proBNP, hsCRP, and MPO. Not for use as routine quality control or calibration materials. Not for use on systems employing reflectance spectroscopy.

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® CM1 Calibration Verification / Linearity Test Set (K090475)

Submission Summary (Full Text)

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

A. 510(k) Number:
k090475

B. Purpose for Submission:
New device

C. Measurand:
Calibrator/Control material for Troponin-I (TnI), Troponin-T (TnT), BNP, the N-amino terminus of brain naturiuretic peptide (NT-proBNP), high sensitive C-reactive protein (hsCRP), and Myeloperoxidase (MPO).

D. Type of Test:
Control Material

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE CM2 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:
JJY, Multi-analyte controls, all kinds (assayed)
4. Panel:
Clinical Chemistry (75)

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## H. Intended Use:

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

2. Indications(s) for use:
VALIDATE CM2 Calibration Verification/Linearity Test Set solutions 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. Each VALIDATE CM2 Calibration Verification/Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-I, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

3. Special conditions for use statement(s):
VALIDATE CM2 Calibration Verification/Linearity Test solutions are not intended for use as routine quality control materials or as calibration materials.

These solutions are not intended for use on systems employing reflectance spectroscopy.

4. Special instrument requirements:
Automated, semi-automated, and manual chemistry systems.

## I. Device Description:

VALIDATE CM2 Calibration Verification/Linearity Test Set is in a human serum matrix that is compatible with chemistry systems for measuring Troponin-I (TnI), Troponin-T (TnT), BNP, the N-amino terminus of brain naturiuretic peptide (NT-proBNP), high sensitive C-reactive protein (hsCRP), and Myeloperoxidase (MPO). Each test set contains two sets of bottles. Set 1 contains TnI, BNP, hsCRP, and MPO; Set 2 contains TnT, NT-proBNP, hsCRP, and MPO. There is a bottle of base matrix included with each set. Each bottle contains 2.0 mL of solution. There exists a linear relationship among Levels 1 through 5.

Material of human origin used in the manufacture of this test set has been tested using FDA approved methods or methods cleared in compliance with the European Directive 98/79/EC, Annex I, III, or IV and found to be non-reactive for HBsAg and antibodies to HCV and HIV-1/2.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
VALIDATE CM1 Calibration Verification/Linearity Test Set.

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

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k053247

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device: VALIDATE CM2 | Predicate: VALIDATE CM1 |
| Intended Use | VALIDATE CM2 Calibration Verification/Linearity Test Set solutions 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. | The Validate Cardiac Marker Calibration Verification Test Sets are used for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated, and manual chemistry analyzers. |
| Matrix | Human Serum | Human Serum |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Stability | Until expiration | Until expiration |
| Storage | -10 to -20°C | -10 to -20°C |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Set 1: BNP, hs-CRP, TnI, MPO
Set2: NT-proBNP, hsCRP, TnT, MPO | CK-MB, MYO |
| Number of Levels | 2 sets of 6 including base matrix | 5 including a 0 |
| Packaging | 12 x 2.0 mL | 5 x 3.0 mL |

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.

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b. Linearity/assay reportable range:
Not Applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability: No traceability claims were made.
Stability: Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Test sets are stable until the expiration date printed on the bottle when stored at -10° to -20°C and handled according to instructions. A maximum of four (4) freeze-thaw cycles are recommended.
Value Assignment: The raw materials are prepared at high concentration, analyzed, and are spiked into the human serum matrix. A linear relationship is achieved by mixing the low and high levels to produce five levels with equally spaced concentrations. For value assignment the high and low levels (1 and 5) are assayed in triplicate. Once all the levels are diluted all 5 levels are run again in triplicate, and then again in triplicate once bottled. Appropriate controls for a given system are run with each determination and must fall within the cited acceptance range. 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.

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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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