DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

K053531 · Dade Behring, Inc. · CEC · Mar 3, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053531
• Device Name: DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: CEC · Clinical Chemistry
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Intended Use

The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is an in-vitro diagnostic test for the quantitative measurement of Free thyroxine in human serum and plasma. The Dimension Vista™ LOCI I Calibrator is an in-vitro diagnostic product intended for the calibration of Thyroid Stimulating Hormone (TSH), Free Triodothyronine (FT3), and Free Thyroxine (FT4).

Device Story

The Dimension Vista™ FT4 assay is a homogenous, sequential, chemiluminescent immunoassay utilizing Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. The system uses two latex bead reagents: Chemibeads coated with T3 and Sensibeads coated with streptavidin. A biotinylated anti-T4 monoclonal antibody binds to free T4 in the patient sample. Non-saturated antibody binds to T3-coated Chemibeads; Sensibeads then bind to the biotin. Upon 680 nm illumination, Sensibeads convert dissolved oxygen to singlet oxygen, which diffuses to Chemibeads to trigger a chemiluminescent signal at 612 nm. The signal is inversely proportional to the free T4 concentration. The device is intended for use on automated clinical chemistry systems in a laboratory setting. Results assist clinicians in evaluating thyroid function and metabolic status. The LOCI 1 Calibrator is a multi-analyte liquid product (bovine serum albumin matrix) used to calibrate the assay, with values traceable to established comparative methods and WHO standards.

Clinical Evidence

Clinical performance was established via a split-sample method comparison study against the predicate ADVIA Centaur FrT4 assay. The study analyzed 108 clinical patient serum samples. Results showed a correlation coefficient (r) of 0.983, a slope of 1.03, and an intercept of 0.02, supporting substantial equivalence.

Technological Characteristics

Chemiluminescent immunoassay (LOCI™ technology). Reagents: biotinylated anti-T4 mouse monoclonal antibody, T3-coated Chemibeads, streptavidin-coated Sensibeads. Energy source: 680 nm light excitation. Detection: 612 nm chemiluminescence. Matrix: Bovine serum albumin (calibrator). Automated clinical chemistry system integration. Assay range: 0.1 - 8.0 ng/dL. Sample volume: 10 µL.

Indications for Use

Indicated for the quantitative measurement of free thyroxine in human serum and plasma to assess clinical metabolic status and aid in the diagnosis and treatment of thyroid disease. Also indicated for the calibration of TSH, FT3, and FT4 assays.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Predicate Devices

• ADVIA Centaur FrT4 assay (unknown)
• Thyroid Calibrator (K970389)

Submission Summary (Full Text)

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2006 MAR 3

K 05353/

### Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Lorraine H Piestrak |
|-------------------|-----------------------|
| | Dade Behring Inc. |
| | P.O. Box 6101 |
| | Newark, DE 19714-6101 |

Date of Preparation: December 16, 2005

### Name of Product:

Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Dimension Vista™ LOCI 1 Calibrator

### FDA Classification Name:

| Free Thyroxine test system | (Class II) |
|----------------------------|------------|
| Calibrator, Secondary | (Class II) |

### Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| New<br>Product | Predicate<br>Device | 510(k)<br>number | Device<br>Class | Regulation | Product<br>Code |
|---------------------------------------------------------------------|--------------------------|------------------|-----------------|------------|-----------------|
| Dimension Vista™ Free<br>Thyroxine (FT4) Flex® reagent<br>cartridge | ADVIA Centaur FrT4 assay | unknown | II | 862.1695 | CEC |
| Dimension Vista™<br>LOCI 1 Calibrator | Thyroid Calibrator | K970389 | II | 862.1150 | JIT |

### Device Description:

The FT4 method is a homogenous, sequential, chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. The LOCI™

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reagents include two latex bead reagents and a biotinylated anti-T4 mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with triiodothyronine (T3), a naturally occurring, weaker binding analog of T4. and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated antibody which allows T4 from the sample to saturate a fraction of the biotinylated antibody that is directly related to the free T4 concentration. In a second step, T3 chemibeads are added and form bead/ biotinylated antibody immunocomplexes with the non-saturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. When illuminated by light at 680 nm, sensibeads convert dissolved oxygen in the reaction solution into the singlet oxygen form ('O2). In the bead pairs, the singlet oxygen diffuses ("channels") into chemibeads, triggering a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is an inverse function of the concentration of free T4 in the sample.

The Dimension Vista™ LOCI I Calibrator is a three level, liguid, multi-analyte product. This product's matrix is bovine serum albumin and it contains buffer, stabilizer and preservatives. Level A is a zero level, while levels B and C contain human thyroxine, triodothyronine and thyroid stimulating hormone. Values are assigned to the calibrator from a masterpool that is traceable through a patient correlation study to an existing comparative method for FT3 and FT4. The TSH value is referenced to the WHO standard, 2nd IRP 80/588, and confirmed with the 3rd IS 81/565.

## Intended Use:

The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is an in-vitro diagnostic test for the quantitative measurement of Free thyroxine in human serum and plasma.

The Dimension Vista™ LOCI I Calibrator is an in-vitro diagnostic product intended for the calibration of Thyroid Stimulating Hormone (TSH), Free Triodothyronine (FT3), and Free Thyroxine (FT4).

## Comparison to Predicate Device:

Both the Dimension Vista™ Free Thyroxine Flex® reagent cartridge and the predicate Advia Centaur FrT4 assay employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:

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| Feature | Dimension Vista™ Free<br>Thyroxine (FT4) Flex® reagent<br>cartridge | ADVIA Centaur FrT4 assay |
|--------------|---------------------------------------------------------------------|----------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | serum |
| Assay Range | 0.1 - 8.0 ng/dL | 0.1 - 12.0 ng/dL |
| Technology | chemiluminescent | chemiluminescent |
| Sample Size | 10 µL | 25 µL |
| Antibody | Anti - T4 mouse monoclonal | Anti -T4 rabbit polyclonal |

| Feature | Dimension Vista™ LOCI I Calibrator | Dimension® Thyroid Calibrator |
|--------------|-------------------------------------------------------------|-------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Analytes | FT4, TSH, FT3 | FT4, TSH |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Form | liquid | liquid |
| Volume | A 2.5 mL per vial<br>B 1.5 mL per vial<br>C 2.0 mL per vial | 2 mL per vial |
| Levels | 3 levels | 5 levels |

## Comments on Substantial Equivalence:

Split sample comparison between the Dimension Vista™ FT4 Flex™® reagent cartridge and ADVIA Centaur FrT4 assay gave the following correlation statistics, when tested with clinical patient samples:

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| Dimension<br>Vista™ | Predicate | Sample<br>Type | Slope | Intercept | Correlation<br>Coefficient (r) | n |
|---------------------|-----------------------|----------------|-------|-----------|--------------------------------|-----|
| FT4 | ADVIA Centaur<br>FrT4 | Serum | 1.03 | 0.02 | 0.983 | 108 |

#### Method Comparison Data sion VistaTM FT4 vs Predicate Method

## Conclusion:

The Dimension Vista™ FT4 Flex® reagent cartridge with the associated LOCI I calibrator is substantially equivalent in principle and performance to the ADVIA Centaur FrT4 assay based on the split sample comparison discussed above.

Louanie H Restrole

Lorraine H Piestrak Regulatory Affairs & Compliance Manager December 16, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is arranged on a single line. The font is simple and easy to read. The text is likely part of a document or sign.

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2006 MAR 3

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE 19714- 6101

Re: k053531

Trade/Device Name: Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Dimension Vista™ LOCI 1 Calibrator Regulation Number: 21 CFR\$862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC, JIT Dated: December 16, 2005 Received: December 19, 2005

Dear Ms. Piestrak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K053531

Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Device Name:

Indications For Use:

The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use --------(21 CFR 801)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ivision Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053531

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# Indications for Use

510(k) Number (if known): K053553

Device Name:

Dimension Vista™ LOCI 1 Calibrator

Indications For Use:

The Dimension Vista™ LOCI I Calibrator is a device intended for medical purposes for use in a the Dithenston + Iba - Dints of reference that are used in the determination of values in the test are creating of Free Thyroxine (FT4), Free Triiodothyronine (FT3), and Thyroid Stimulating Hormone (TSH) in human specimens.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use --------(21 CFR 801)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

g Page 1 of

C.H

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053531