DIMENSION EXL WITH LM SYSTEM

K130276 · Siemens Healthcare Diagnostics, Inc. · JJE · Mar 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130276
• Device Name: DIMENSION EXL WITH LM SYSTEM
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Mar 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensory technology for chemical and immunochemical applications for clinical use. The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

Device Story

Dimension® EXL™ with LM is a floor-model, fully automated, microprocessor-controlled clinical chemistry analyzer. It processes human serum and plasma samples using photometric, turbidimetric, chemiluminescent, and ion-selective multisensor technologies. The system utilizes prepackaged Flex® reagent cartridges. This submission specifically addresses a change in the photomultiplier tube (PMT) used for LOCI® chemiluminescent immunoassays. The LOCI® method involves a sequential reaction: sample incubation with biotinylated anti-T4 antibody; addition of T3-coated Chemibeads; and addition of streptavidin-coated Sensibeads. Illumination at 680 nm triggers singlet oxygen diffusion from Sensibeads to Chemibeads, producing a chemiluminescent signal at 612 nm inversely proportional to FT4 concentration. Operated by laboratory technicians in clinical settings, the system provides quantitative results to assist physicians in diagnosing and monitoring thyroid disease.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days using commercial controls and patient pools; results showed comparable performance between new and current PMT. Linearity verified across 0.1–8.0 ng/dL range (R²=1.00). Method comparison against predicate using 45 patient samples showed high correlation (r=0.998, slope=0.97). Limit of Blank (LoB) verified at 0.03 ng/dL and Limit of Detection (LoD) at 0.06 ng/dL.

Technological Characteristics

Floor-model, fully automated, microprocessor-controlled analyzer. Uses LOCI technology (chemiluminescent immunoassay). Reagents: prepackaged Flex cartridges containing synthetic beads and biotinylated mouse monoclonal antibodies. Detection: Photomultiplier tube (enhanced glass single surface tube). Connectivity: LINUX-based system. Temperature control: 37°C for reactions, 2-8°C for reagent storage. Sample volume: 10 μL.

Indications for Use

Indicated for quantitative measurement of Free Thyroxine in human serum and plasma for diagnosis and monitoring of thyroid disease in patients.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• Dimension® EXL™ with LM system including FT4L assay (k073604)

Submission Summary (Full Text)

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# 510(k) Summary

## MAR 2 2 2013

#### 5.1 Description

Dimension® EXL™ with LM system

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

## 5.2. Assigned 510(k) number

The assigned 510(k) number is: k130276

## 5.3 Applicant and Date

- Pamela A. Jurga Applicant: Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714-6101
March 20, 2013 Date:

#### 5.4 Proprietary and Established Names

Dimension® EXL™ with LM system Dimension® FT4L Flex® reagent cartridge

#### 5.5 Regulatory Information

Dimension® EXL™ with LM system (instrument)

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use. This 510(k) is being submitted because of a change in the photomultiplier tube (from a new vendor) that will be used to count the signal for the chemiluminescent methods (LOCI).

Regulation section: 21CFR 862.2160 Analyzer, chemistry (photometric, discrete), For Clinical Use Classification: Class I Product Code: JJE Panel: Clinical Chemistry

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The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

Regulation section: 21CFR 862.1695, free thyroxine Classification: Class II Product Code: CEC Panel: Clinical Chemistry

## 5.6 Predicate Device

The predicate device used to demonstrate substantial equivalence to the Dimension® EXL™ with LM system with the new photomultiplier tube (PMT) is the Dimension® EXLTM with LM system cleared under k073604 including the FT4L assay.

The predicate device used to demonstrate substantial equivalence to the Dimension® FT4L Flex® reagent cartridge is the Dimension® FT4L Flex® reagent cartridge cleared under k073604 with the Dimension® EXL™ with LM system.

#### 5.7 Device Description / Test Principle

The Dimension EXL with LM system is a floor model, fully automated, microprocessorcontrolled, integrated instrument which uses prepackaged Siemens Dimension Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or STAT modes. The instrument has a heterogeneous module (HM) for processing chromium-based heterogeneous immunoassays and a LOCI® module for chemiluminescent immunoassays. The instrument can also perform photometric, turbidimetric and ACMIA tests. This 510(k) is being submitted because a new photomultiplier (from a different vendor) will be used to count the signal for the chemiluminescent methods (LOCI).

The Dimension® FT4L Flex® regent cartridge consists of prepackaged liquid reagents containing two synthetic beads, and a biotinvlated anti-T4 mouse monoclonal antibody in a plastic eight-well cartridge.

The FT4L method is a homogeneous, sequential, chemiluminescent immunoassay based on. LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-T4 mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with trijodothyronine (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 thvroxine (FT4) concentration. In a second step, T3 Chemibeads are added and form bead/biotinylated antibody immunocomplexes with the nonsaturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet . oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent

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| Reagents | | | | |
|----------|--------|---------------------------------|----------------|---------------------|
| Wellsa,b | Form | Ingredient | Concentration. | Source |
| 1 – 2 | Liquid | Streptavidin<br>Sensibeads | 225 µg/mL | Recombinant E. coli |
| 3 – 4 | Liquid | T3<br>Chemibeads | 200 µg/mL | |
| 5 – 6 | Liquid | FT4<br>Biotinylated<br>antibody | 50 ng/mL | Mouse monoclonal |
| 7 – 8 | Empty | | | |

reaction. The resulting signal is measured at 612 nm and is an inverse function of the FT4 concentration in the sample.

## 5.8 Intended Use

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric. turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

## 5.9 Indication(s) for Use

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

## 5.10 Substantial Equivalence Information

The Dimension® EXL™ with LM system with new PMT and the Dimension® EXL™ with LM system cleared under k073604 are in vitro diagnostic devices that are intended to measure a variety of analytes in human body fluids. The systems utilize photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use. To ensure substantial equivalence with the new photomultiplier tube (PMT) from a different vendor, a representative method impacted by this change was tested with instruments with both the new and the current PMT. Data from a representative chemiluminescent method, LOCI Free thyroxine Flex® reagent cartridge, is included in this submission. Comparative data for Method Comparison, and Precision (with in run, within lab) demonstrate equivalent performance.

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A comparison of the similarities and differences between the devices is provided in the following tables:

| Feature | Device:<br>Dimension® EXLTM with LM<br>with new PMT | Predicate:<br>Dimension® EXLTM with LM<br>(k073604) |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | The Dimension® EXLTM with<br>LM system is an <i>in vitro</i><br>diagnostic device that is intended<br>to measure a variety of analytes<br>in human body fluids. The<br>system utilizes photometric,<br>turbidimetric,<br>chemiluminescence and<br>integrated ion selective<br>multisensor technology for<br>chemical and immunochemical<br>applications for clinical use. | Same |
| Indications for<br>Use | The Dimension® EXLTM with<br>LM system is an <i>in vitro</i><br>diagnostic device that is intended<br>to measure a variety of analytes<br>in human body fluids. The<br>system utilizes photometric,<br>turbidimetric,<br>chemiluminescence and<br>integrated ion selective<br>multisensor technology for<br>chemical and immunochemical<br>applications for clinical use. | Same |
| System Control | Fully automated and controlled<br>by microprocessors | Same |
| User Interface | Contains graphical user interface<br>screens | Same |
| Detection<br>Technologies | Contains a photometer, a<br>heterogeneous module and a<br>multisensor electrode for | Same |
| | performing photometric tests,<br>and electrolyte tests. It also has<br>a LOCI® module for high-<br>sensitivity homogenous<br>immunoassay tests. | |
| Reagents | Uses pre-packaged Flex® reagent cartridges. Reagents are hydrated and stored on-board the instrument | Same |
| Temperature | Reagents are stored at 2 - 8°C.<br>Reactions are controlled at 37°C. | Same |
| Operating System | LINUX Operating System | Same |
| Photomultiplier<br>tube used to count<br>the signal in the<br>chemiluminescent<br>methods | * Contains a faceplate<br>* Contains a photocathode<br>* Contains an anode at end | Same |

Similarities for Dimension® EXL™ with LM with new PMT and Dimension® EXL™ with LM:

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## Differences for Dimension® EXL™ with LM with new PMT and Dimension® EXL ™ with LM:

| Feature | Device:<br>Dimension® EXL™ with LM<br>with new PMT | Predicate:<br>Dimension® EXL™ with LM<br>(k073604) |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------|
| Photomultiplier<br>tube used to count<br>the signal in the<br>chemiluminescent<br>methods | Vendor: Hamamatsu<br>Multiplier channel: multiple<br>dynodes | Vendor: Excelitas<br>Multiplier channel: Enhanced<br>Glass Single Surface Tube |

.

. . . . . . .

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| Feature | Device:<br>Dimension® FT4L Flex®<br>reagent cartridge | Predicate:<br>Dimension® FT4L Flex®<br>reagent cartridge<br>(k073604) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | The FT4L method is an in<br>vitro diagnostic test for the<br>quantitative measurement of<br>Free Thyroxine in human<br>serum and plasma on the<br>Dimension® EXL™ with<br>LM system. Measurements<br>of free thyroxine are used in<br>the diagnosis and<br>monitoring of thyroid<br>disease. | Same |
| Assay Range | 0.1-8.0 ng/dL | Same |
| Sample Type | Human serum and plasma | Same |
| Technology | LOCI® technology | Same |
| Sample size | 10 µL | Same |
| Reagents and antibody | There are three (3) reagents-<br>Streptavidin sensibeads, T3<br>Chemibeads and FT4<br>biotinylated antibody<br>(containing mouse<br>monoclonal antibody) | Same |

Similarities and Differences for Dimension® FT4L Flex® reagent cartridge:

## 5.11 Standard/Guidance Document Reference

· Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2)

Evaluation of Precision Performance of Quantitative Measurement Methods: . Approved Guideline (EP5-A2)

· In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions -Jan. 1997

- Format for Traditional and Abbreviated 510(k)'s Guidance for Industry and Staff -. Nov. 17, 2005 Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization - May 7, 2008

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## 5.12 Performance Characteristics

#### 5.12.1 Method Comparison

The FT4L method was evaluated on the Dimension® EXL™ with LM system with new PMT and the Dimension® EXL™ with LM system with the current photomultiplier tube (CPM). Remnant de-identified human serum samples were tested. No patient history information was obtained on these samples. Inclusion data criteria are not applicable. None of the samples were spiked.

These studies were conducted internally by Siemens Healthcare Diagnostic Inc. R & D organization personnel. The personnel conducting the study were laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting. They were trained on the operation of both the device and the predicate device. A split sample method comparison, following EP09-A2, demonstrated good agreement between the Dimension EXL FT4L method with the Dimension® EXLTM with LM system with new PMT and the predicate Dimension® EXL™ with LM system with the current photomultiplier tube. Only those patient results that were within the assay range were included in this analysis.

Forty five patient samples across the FT4L assay range were tested on both platforms. The results were analyzed by Passing Bablok and linear regression statistics. The correlation coefficient was obtained by linear regression. Although the samples were tested in duplicate, only the first result was used for the analysis.

| Method | Range<br>(ng/mL) | Slope<br>(95% CI) | Intercept<br>ng/dL<br>(95% CI) | Correlation<br>Coefficient<br>(std linear<br>regression) | n |
|--------------------------------|------------------|-----------------------|--------------------------------|----------------------------------------------------------|----|
| FT4L<br>(Passing<br>Bablok) | 0.23 – 7.78 | 0.99<br>(0.96 – 1.01) | -0.03<br>(-0.07 – 0.00) | Not applicable | 45 |
| FT4L<br>(linear<br>regression) | 0.23 - 7.78 | 0.97 | 0.00 | 0.998 | 45 |

The model equation for the regression statistics is: [results for Dimension® EXL™ with LM system with new PMT] = slope x [Dimension® EXL™ with LM system with current PMT] + intercept.

#### 5.12.2 Precision

Precision testing was performed in accordance with CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline - Second Edition. Samples consisted of three (3) commercial quality controls (BioRad Liquichek Immunoassay

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QC) and two (2) patient serum pools. Testing was performed over twenty (20) days, one (1) run per day for each test material on the Dimension EXL with LM systems with both the new and the current PMT. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EPS-A2. The acceptance criteria are as follows or must be determined to be substantially equivalent to the predicate device.

| FT4L target<br>concentration<br>(ng/dL) | BioRad QC<br>EXL LOCI Module<br>Concentration<br>(ng/dL) | Repeatability<br>(CV %) | With-in Lab<br>(CV %) |
|-----------------------------------------|----------------------------------------------------------|-------------------------|-----------------------|
| $0.6 \pm 0.2$ (0.4-0.8)* | 0.859-1.29 | $\leq 5.0$ | $\leq 7.0$ |
| $1.5 \pm 0.4$ (1.1-1.9) | 1.68-2.52 | $\leq 3.0$ | $\leq 5.0$ |
| $4.0 \pm 2.0$ (2.0-6.0) | 3.86-5.78 | $\leq 3.0$ | $\leq 5.0$ |

*Note: The values obtained for BioRad Liquicheck Immunoassav OC Level 1 (mean of 0.89 and 0.91) are slightly higher than the target concentration of 0.4-0.8 ng/mL, but are consistent with the QC concentration for the EXL LOCI module of 1.0 ng/mL.

The precision observed is within the acceptance criteria for all 3 target concentrations.

The data are summarized in the following tables:

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## Current PMT FT4L assay

| Sample | Mean (ng/dL) | Repeatability | | With-in Lab | |
|-----------------------------------------------------------------|--------------|---------------|-----|-------------|-----|
| | | SD (pg/mL) | %CV | SD (pg/mL) | %CV |
| Quality Control - BioRad Liquichek Immunoassay lot number 40780 | | | | | |
| Level 1 | 0.91 | 0.02 | 2.5 | 0.03 | 3.0 |
| Level 2 | 2.39 | 0.06 | 2.4 | 0.08 | 3.0 |
| Level 3 | 7.01 | 0.10 | 2.5 | 0.03 | 3.0 |
| Patient Pools (serum) | | | | | |
| Pool 1 | 1.18 | 0.03 | 2.5 | 0.03 | 3.0 |
| Pool 2 | 3.86 | 0.07 | 1.7 | 0.08 | 2.0 |

New PMT FT4L assay

.

| | | Repeatability | | With-in Lab | |
|-----------------------------------------------------------------|--------------|---------------|-----|-------------|-----|
| Sample | Mean (ng/dL) | SD (pg/mL) | %CV | SD (pg/mL) | %CV |
| Quality Control - BioRad Liquichek Immunoassay lot number 40780 | | | | | |
| Level 1 | 0.89 | 0.02 | 2.0 | 0.03 | 3.4 |
| Level 2 | 2.44 | 0.05 | 1.9 | 0.07 | 2.8 |
| Level 3 | 6.85 | 0.10 | 1.5 | 0.17 | 2.4 |
| Patient Pools (serum) | | | | | |
| Pool 1 | 1.17 | 0.02 | 1.7 | 0.03 | 2.7 |
| Pool 2 | 3.93 | 0.06 | 1.6 | 0.07 | 1.7 |

.

.

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## 5.13 Traceability

Calibrator Traceability:

USP-grade thyroxine is spiked into stripped human serum at different concentrations. This becomes the "Anchor Pool". The "Anchor Pool" values are validated in-house.

A Master Pool is developed from stripped bovine albumin to which different concentrations of thyroxine have been added. Values for the Master Pool are derived by multiple analyses against the Anchor Pool calibration curve. LOCI® Thyroid Calibrator value assignment is established by measurement against the Master Pool calibration.

## 5.14 Conclusion

Regression analysis of a split sample comparison of the FT4L assay with Dimension ® EXL™ with LM with both the new and the current PMT gave a correlation coefficient of 0.998, a slope of 0.99 and an intercept of -0.03 ng/dL when tested with 45 patient sample ranging from 0.23-7.78 ng/dL. This demonstrates that the Dimension® EXL™ with LM system with new PMT and the FT4L assay are substantially equivalent in principle and performance to the Dimension® EXL™ with LM system and the FT4L assay cleared under k073604.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2013

Siemens Healthcare Diagnostics, Inc. c/o Pamela A. Jurga 500 GBC Drive, M/S 514 P. O. Box 6101 Newark, DE 19714-6101

Re: k130276

Trade/Device Name: Dimension® FT4L Flex reagent cartridge, Dimension® EXL™ with LM System Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: II Product Code: CEC, JJE Dated: February 4, 2013 Received: February 5, 2013

Dear Ms. Jurga:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Carol C. Benson - S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): k130276

Device Name: Dimension® EXL™ with LM system Dimension® FT4 Flex® reagent cartridge

Indications for Use:

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chesler S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k130276

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