DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250

K061885 · Dade Behring, Inc. · JIT · Aug 14, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061885
• Device Name: DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista™ System. For prescription use

Device Story

T3 CAL is a liquid, human serum-based calibrator containing L-triiodothyronine; used to calibrate Total Triiodothyronine (T3) assays on the Dimension Vista™ System. Kit includes six vials (three of Calibrator A, three of Calibrator B). Product is ready-to-use; no preparation required. Human source materials tested negative for HIV-1/2, HbsAg, and HCV. Used by laboratory professionals to ensure accuracy of T3 measurements, which support clinical assessment of thyroid function.

Clinical Evidence

No clinical data. Bench testing only. Traceability established via USP L-triiodothyronine. Stability protocols and acceptance criteria were reviewed and found acceptable.

Technological Characteristics

Liquid, stripped human serum-based calibrator. Two-level configuration. Traceable to USP L-triiodothyronine (Catalog #36800). Designed for use with Dimension Vista™ System. Complies with CEN 13640 (stability) and ISO 14971:2000 (risk management).

Indications for Use

Indicated for the calibration of Total Triiodothyronine (T3) methods on the Dimension Vista™ System in clinical laboratory settings.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® Total Triiodothyronine Calibrator (k032697)

Submission Summary (Full Text)

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

A. 510(k) Number:
k061885

B. Purpose for Submission:
510(k) premarket notification package to manufacture and market the Dimension Vista™ System Total Triiodothyronine Calibrator (T3CAL-KC250).

C. Measurand:
Calibrator for Total Triiodothyronine (T3)

D. Type of Test:
Calibrator

E. Applicant:
Dade Behring, inc.

F. Proprietary and Established Names:
Dimension Vista™ System Total Triiodothyronine Calibrator (T3CAL-KC250).

G. Regulatory Information:
1. Regulation section:
862.1150 – Calibrator
2. Classification:
Class II
3. Product code:
Calibrator, Secondary (JIT)
4. Panel:

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Clinical Chemistry (75)

## H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista™ System.

3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
Dimension Vista™ System

## I. Device Description:

The T3 CAL is a liquid, human serum based product containing L-triiodothyronine. The kit consists of six vials, three vials of Calibrator A (2.0 mL per vial) and three vials of Calibrator B (1.5 mL per vial). T3 CAL is ready for use, no preparation is required.

All human source materials were tested by FDA approved methods and found to be negative for antibodies to HIV-1/2, HbsAg, and HCV.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension® Total Triiodothyronine Calibrator

2. Predicate 510(k) number(s):
k032697

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Dimension Vista™ System Total Triiodothyronine Calibrator (T3CAL-KC250) | Dimension® Total Triiodothyronine Calibrator |
| Traceability | Traceable to United States Pharmacopeia (USP) L-triiodothyronine (USP Catalog #36800). | Traceable to United States Pharmacopeia (USP) L-triiodothyronine (USP Catalog #36800). |
| Form/Matrix | Liquid stripped human serum based. | Liquid stripped human serum based. |
| Differences | | |
| --- | --- | --- |
| Item | Dimension Vista™ System Total Triiodothyronine Calibrator (T3CAL-KC250) | Dimension® Total Triiodothyronine Calibrator |
| Intended use | The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista™ System. | The Dimension® Total Triiodothyronine (T3) Calibrator (RC4 14) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module. |
| Levels | Two levels | Five levels |

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

CEN 13640, Stability Testing of In Vitro Diagnostic Reagents

ISO 14971:2000, Medical devices - Application of risk management to medical devices

FDA Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final

FDA Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

# L. Test Principle:

Not Applicable

# M. Performance Characteristics (if/when applicable):

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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
The assigned values of the calibrators are traceable to United States Pharmacopeia (USP) L-triiodothyronine (USP Catalog #36800).

Value Assignment
The master pool is manufactured by weighing USP T3 into stripped human serum at five levels. The master pool bottle values are assigned by calibration with a previous master pool using multiple replicates on multiple instruments.

The commercial calibrators are manufactured by weighing purified T3 into stripped human serum at two levels. Bottle values are assigned by calibration with the master pool using multiple replicates on multiple instruments.

Stability
Protocols and acceptance criteria were described and found to be acceptable.

d. Detection limit:
Not Applicable

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

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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 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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