VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

K083891 · Maine Standards Co. · JJY · Mar 23, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083891
• Device Name: VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.

Device Story

VALIDATE® THY Calibration Verification Test Set is a human serum-based quality control material; used to establish relationship between theoretical operation and actual performance of clinical chemistry analyzers. Device consists of two sets: THY set (T3, T4, TSH, cortisol) and FT4 set (Free T4); each provided in five levels with a linear relationship between levels. Used in clinical laboratories by technicians or laboratory staff to verify reportable ranges and calibration of chemistry systems. Output is a set of known-concentration samples; healthcare providers compare measured values against expected values to ensure system accuracy and linearity. Benefits include improved confidence in patient test results and identification of potential system drift or calibration errors.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Traceability to NIST SRM or primary analytical standards is maintained.

Technological Characteristics

Human serum-based matrix; five-level concentration design; liquid form factor. Designed for use in automated, semi-automated, and manual chemistry systems. No specific materials or software algorithms described.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of T3, T4, TSH, cortisol, and Free T4 assays in automated, semi-automated, and manual chemistry 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

• VALIDATE® Thyroid Calibration Verification/Linearity Test Set (k062501)

Submission Summary (Full Text)

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

A. 510(k) Number:
k083891

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification materials for Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), Cortisol, and Free T4 (FT4).

D. Type of Test:
Calibration verification materials

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE® THY Calibration Verification Test Set

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material
2. Classification:
Class I, reserved
3. Product Code:
JJY
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for Use below
2. Indication(s) for use:
VALIDATE THY Calibration Verification Test Set consists of two sets of bottles, a THY set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating

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Hormone (TSH), and Cortisol, and the FT4 set consists of five (5) levels containing Free Thyroxine (FT4).

VALIDATE THY Calibration Verification 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.

3. Special condition for use statement(s): Prescription Use Only

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

I. Device Description: VALIDATE® THY Calibration Verification Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through. Human source material is considered a potentially biohazardous material. These materials were tested and found negative for HIV-1/2, HCV, HBV, and HBsAg. Because no test method can offer complete assurance that infectious agents are absent, these specimens should be handled and treated as potentially infectious.

J. Substantial Equivalence Information:

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

2. Predicate K number(s): k062501

3. Comparison with predicate:

| | Predicate | Device |
| --- | --- | --- |
| Intended Use | For in vitro diagnostic use in quantitative determination of linearity, calibration verification and verification of reportable ranges in automated, semi-automated and manual chemistry systems. | For in vitro diagnostic use in quantitative determination of linearity, calibration verification and verification of reportable ranges in automated, semi-automated and manual chemistry systems. |
| Analytes | T3, T4, TSH, Cortisol | T3, T4, TSH, Cortisol, Free T4 |
| Matrix | human serum | human serum |
| Number of | 5 | 5 |

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| Levels | plus a base matrix | |
| --- | --- | --- |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 3.0 mL each level | 1.5 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | -10 to -20°C | -10 to -20°C |

VALIDATE® THY Calibration Verification Test Set differs from the current product in it includes a set for FT4.

**K. Standard/Guidance Document Referenced (if applicable):**
CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures

**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 (controls, calibrators, or method):**
VALIDATE THY Calibration Verification Test Set 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.
Each lot of the VALIDATE THY Calibration Verification Test Set is manufactured such that a linear relationship exists among the Levels 1 through 5. The expected value of the Base Matrix is zero, however, in some instances a non-zero result may be obtained.
Actual results obtained may vary depending on instrumentation, methodology and assay temperature. Results may also be dependent on the accuracy of the instrument/reagent system calibration. The degree of acceptable non-linearity is an individual judgment based on methodology, clinical significance and medical decision levels of the test analyte.
Stability testing protocols and acceptance criteria were described and found to be acceptable.
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:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and satisfies the requirement of 21 CFR part 809.10

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.