DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K032697 · Dade Behring, Inc. · JIS · Nov 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032697
• Device Name: DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
• Applicant: Dade Behring, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The T3 Calibrator is intended for use in the calibration of Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Device Story

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid, multi-level calibrator kit consisting of 10 vials (two each at five levels). Level 1 contains stripped human serum; levels 2-5 contain L-triiodothyronine in a stripped human serum base. The device is used in a clinical laboratory setting to calibrate the T3 assay on the Dimension® clinical chemistry system equipped with a Heterogeneous Immunoassay Module. By establishing a calibration curve, the device enables the system to accurately quantify T3 concentrations in patient samples, supporting clinical diagnostic decision-making regarding thyroid function.

Clinical Evidence

bench testing only

Technological Characteristics

Liquid calibrator kit; 5 levels (0, 1, 2, 4, 6.5 ng/mL); matrix: stripped human serum base; analyte: L-triiodothyronine. Designed for use with Dimension® clinical chemistry system Heterogeneous Immunoassay Module.

Indications for Use

Indicated for use as a calibrator for the Total Triiodothyronine (T3) assay on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

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

• Opus Total T3 Calibrator (K953160)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number: K032697
B. Analyte: Triiodothyronine (T3)
C. Type of Test: N/A
D. Applicant: Dade Behring Inc.
E. Proprietary and Established Names: Dade Behring Dimension® Total Triiodothyronine (T3) Calibrator (RC414)

F. Regulatory Information:

1. Regulation section: §862.1150, Calibrator, Primary
2. Classification: Class II
3. Product Code: JIS
4. Panel: 75 (Chemistry)

G. Intended Use:

1. Indication(s) for use:
The T3 Calibrator is intended for use in the calibration of Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

2. Special condition for use statement(s): None
3. Special instrument Requirements: Dade Behring Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

H. Device Description:

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-Triiodothyronine in a stripped human serum base.

{1}

Page 2 of 3

# I. Substantial Equivalence Information:

1. Predicate device name(s): Opus Total T3 Calibrator
2. Predicate K number(s): K953160
3. Comparison with predicate:

| | Dimension® T3 Calibrator | Opus Total T3 Calibrator |
| --- | --- | --- |
| Intended Use | Calibrator | Calibrator |
| Analyte | T3 | T3 |
| Matrix | Stripped human serum base | Stripped human serum base |
| Form | Liquid | Liquid |
| Volume | 2 mL per vial @ level 1, 1 mL per vial @ levels 2-5 | 2 mL per vial @ level 1, 1 mL per vial @ levels 2-6 |
| Levels | 5 levels @ 0, 1, 2, 4, 6.5 ng/mL | 6 levels @ 0, 0.5, 1, 2, 4, 6 ng/mL |

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

FDA guidance “Abbreviated 510(k) submissions for In Vitro Diagnostic Calibrators”

# K. Test Principle: N/A

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

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method):

The assigned values are referenced to USP L-Triiodothyronine (USP Catalog # 36800). Users of this product will be notified if there is a change in the assigned values. Systeme International d'Unites Conversion factor: ng/mL x 1.536 = nmol/L

d. Detection limit: N/A
e. Analytical specificity: N/A

{2}

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:

a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when $a$ and $b$ are not applicable):

4. Clinical cut-off: N/A
5. Expected values/Reference range:

The following table shows the calibrator values obtained on the Dimension® Clinical Chemistry System with Heterogeneous Immunoassay Module. Please note the assignment is absolute, there is no range:

| | Assigned Value | Units | Assigned Value | SI Units |
| --- | --- | --- | --- | --- |
| Level 1 | 0 | ng/mL | 0 | nmol/L |
| Level 2 | 1 | ng/mL | 1.5 | nmol/L |
| Level 3 | 2 | ng/mL | 3.1 | nmol/L |
| Level 4 | 4 | ng/mL | 6.1 | nmol/L |
| Level 5 | 6.5 | ng/mL | 9.9 | nmol/L |

# M. Conclusion:

Based on the information provided, I recommend that the Dade Behring Dimension® Total Triiodothyronine (T3) Calibrator is substantially equivalent to the Opus Total T3 Calibrator (K953160) predicate device.