DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

K100778 · Siemens Healthcare Diagnostics · JIX · May 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100778
• Device Name: DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3L), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

Device Story

LOCI Thyroid Calibrator is a multi-analyte, liquid, bovine serum albumin-based product containing triiodothyronine, thyroxine, and human thyroid stimulating hormone. Used in clinical laboratory settings to calibrate specific thyroid hormone assays (FT3, FT4, TSHL) on the Dimension EXL integrated chemistry system with LOCI module. The calibrator ensures the accuracy and reliability of patient test results by establishing a reference point for the instrument's measurement methods. It is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data. Bench testing only. Shelf-life and open-vial stability were demonstrated using real-time data from 3 lots. Value assignment traceability for FT4 and TSH was previously established in k073604 and k081103; FT3 traceability was established via anchor and master pool calibration.

Technological Characteristics

Multi-analyte, liquid, bovine serum albumin-based calibrator. Contains triiodothyronine, thyroxine, and human thyroid stimulating hormone. 5 levels. Storage 2–8 °C. Used on Dimension® EXL™ integrated chemistry system with LOCI® Module.

Indications for Use

Indicated for the calibration of LOCI Free Triiodothyronine (FT3), Free Thyroxine (FT4), and Thyroid Stimulating Hormone (TSHL) assays on the Dimension EXL integrated chemistry system. No specific patient population or contraindications described.

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

• Siemens LOCI® THYR Calibrator (k073604)

Submission Summary (Full Text)

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

A. 510(k) Number:
k100778

B. Purpose for Submission:
Add Triiodothyronine (FT3) to the existing Thyroid Stimulating Hormone (TSH) and Thyroxine (FT4) calibrator materials

C. Measurand:
Calibrator materials for Free Triiodothyronine (FT3) Free Thyroxine (FT4) and Thyroid Stimulating Hormone (TSH)

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics, Inc

F. Proprietary and Established Names:
LOCI Thyroid Calibrator

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIX | Class II | 21 CFR§ 862.1150 | Chemistry |

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

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2. Indication(s) for use:

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3L), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

For use with the Dimension® EXL™ integrated chemistry system with LOCI® Module

I. Device Description:

The LOCI Thyroid Calibrator is a multi-analyte, liquid, bovine serum albumin based product containing triiodothyronine (FT3), thyroxine (FT4) and human thyroid stimulating hormone (TSH). The kit consists of ten vials with two vials per level containing 2.0 mL per vial.

The calibrator levels and their assigned values are:

| | Level 2 | Level 3 | Level 4 | Level 5 | Level 6 |
| --- | --- | --- | --- | --- | --- |
| FT4L | --- | 0.80 ng/mL | 1.60 ng/mL | 4.00 ng/mL | 8.40 ng/mL |
| TSHL | 0.00 μIU/mL | 4.00 μIU/mL | 20.00 μIU/mL | 50.00 μIU/mL | 105.00 μIU/mL |
| FT3L | 0 pg/mL | 2 pg/mL | 6 pg/mL | 15 pg/mL | 31.5 pg/mL |

*Level 1 is not included in the LOCI Thyroid Calibrator carton. Reagent grade water must be used as the Level 1 calibrator for the FT4L method.

All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA licensed tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Siemens LOCI® THYR Calibrator

2. Predicate 510(k) number (s)

k073604

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| Similarities | | |
| --- | --- | --- |
| Item | LOCI Thyroid Calibrator (candidate device) | LOCI Thyroid Calibrator predicate device (k073604) |
| Intended Use | Calibration materials for the Dimension® EXL™ integrated chemistry system with LOCI® Module | Same |
| Analyzer | Dimension® EXL™ with LM system. | Same |
| Matrix | Bovine Serum Albumin | Same |
| Levels | 5 Levels | Same |
| Preparation | Liquid | Same |
| Storage | 2-8°C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate |
| Analytes | LOCI Free Triiodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) | LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) |

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

None referenced

# 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):

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Traceability and value assignment for free thyroxine (FT4) and thyroid stimulating hormone (TSH) in the calibrator were previously described in k073604 and k081103 respectively and has not been modified.

Traceability and value assignment for triiodothyronine (FT3) involves preparation of anchor and pools and master pools. The anchor pool is prepared from USP grade 3, 3', 5-triiodo-L-thyronine (T3) spiked in a human serum matrix. Seven levels of anchor pool are prepared. A Master Pool is developed from a bovine albumin based matrix to which different concentrations of 3, 3', 5-triiodo-L-thyronine have been added. Values for the Master Pool are derived by multiple analyses against the Anchor Pool calibration curve. The LOCI Thyroid Calibrator value assignment is established by measurement against the Master Pool calibration.

The shelf-life and open-vial stability of the LOCI Thyroid Calibrator when stored at 2-8°C have been demonstrated using real time data collected from 3 lots of calibrators. The predetermined acceptance criteria and protocols were reviewed and found to be acceptable.

For the LOCI Thyroid Calibrator, the sponsor claims a shelf life of 12 months when unopened and stored at 2-8°C. Once opened, the LOCI Thyroid Calibrator is stable for 3 months when recapped and stored at 2-8°C.

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

3. Clinical studies:

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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:

An example of the lot specific target values and acceptance range are as follows:

| Level | Target | Acceptance Range |
| --- | --- | --- |
| TSH | μIU/mL | μIU/mL |
| 2 | 0.00 | -0.005 to +0.005 |
| 3 | 4.00 | 3.60 – 4.40 |
| 4 | 20.0 | 18.0 – 22.0 |
| 5 | 50.0 | 45.0 – 55.0 |
| 6 | 105.0 | 100 - 120 |
| FT4 | ng/mL | ng/mL |
| 2 | 0.00 | -0.10 to +0.30 |
| 3 | 0.80 | 0.74 -0.90 |
| 4 | 1.60 | 1.44 -1.76 |
| 5 | 4.00 | 3.60 – 4.40 |
| 6 | 8.40 | 8.00 – 9.20 |
| FT3 | pg/mL | pg/mL |
| 2 | 0 | -0.5 to +0.5 |
| 3 | 2 | 1.8 – 2.2 |
| 4 | 6 | 5.4 – 6.4 |
| 5 | 15 | 13.5 – 16.5 |
| 6 | 31.5 | 30.0 – 34.6 |

# 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.