(45 days)
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.
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 reaction. The resulting signal is measured at 612 nm and is an inverse function of the FT4 concentration in the sample.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Siemens Dimension® EXL™ with LM system and FT4L Flex® reagent cartridge.
Note: This submission focuses on a change in a photomultiplier tube (PMT) vendor for an existing device. Therefore, the "acceptance criteria" discussed are primarily related to demonstrating that the new PMT does not negatively impact the performance of a representative assay (FT4L) compared to the previously cleared system. This is a comparative effectiveness study rather than assessing absolute performance against disease diagnosis benchmarks.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (New PMT vs. Current PMT on FT4L Assay) | Meets Criteria? |
|---|---|---|---|
| Method Comparison (FT4L Assay) | |||
| Correlation Coefficient (Linear Regression) | Not explicitly stated as a numerical threshold, but implied to be "good agreement" and "substantially equivalent." Typically, a value close to 1.0 indicates strong correlation. | 0.998 | Yes (Excellent) |
| Slope (Passing Bablok) | Expected to be close to 1.0 (indicating proportional agreement). | 0.99 (95% CI: 0.96 – 1.01) | Yes |
| Intercept (Passing Bablok) | Expected to be close to 0.0 (indicating no constant bias). | -0.03 ng/dL (95% CI: -0.07 – 0.00) | Yes |
| Precision (FT4L Assay) - Repeatability (%CV) | FT4L Target: $0.6 \pm 0.2$ ng/dL (0.4-0.8) $\leq 5.0%$ FT4L Target: $1.5 \pm 0.4$ ng/dL (1.1-1.9) $\leq 3.0%$ FT4L Target: $4.0 \pm 2.0$ ng/dL (2.0-6.0) $\leq 3.0%$ | BioRad QC Level 1 (Mean 0.89 ng/dL): 2.0% BioRad QC Level 2 (Mean 2.44 ng/dL): 1.9% BioRad QC Level 3 (Mean 6.85 ng/dL): 1.5% Patient Pool 1 (Mean 1.17 ng/dL): 1.7% Patient Pool 2 (Mean 3.93 ng/dL): 1.6% | Yes (All values are well below the specified CV % limits) |
| Precision (FT4L Assay) - Within-Lab (%CV) | FT4L Target: $0.6 \pm 0.2$ ng/dL (0.4-0.8) $\leq 7.0%$ FT4L Target: $1.5 \pm 0.4$ ng/dL (1.1-1.9) $\leq 5.0%$ FT4L Target: $4.0 \pm 2.0$ ng/dL (2.0-6.0) $\leq 5.0%$ | BioRad QC Level 1 (Mean 0.89 ng/dL): 3.4% BioRad QC Level 2 (Mean 2.44 ng/dL): 2.8% BioRad QC Level 3 (Mean 6.85 ng/dL): 2.4% Patient Pool 1 (Mean 1.17 ng/dL): 2.7% Patient Pool 2 (Mean 3.93 ng/dL): 1.7% | Yes (All values are well below the specified CV % limits) |
Notes on Acceptance Criteria: The document primarily states that the acceptance criteria for precision are either "as follows" (referring to the table provided) or "must be determined to be substantially equivalent to the predicate device." Since the new PMT system demonstrated precision values well within the specified limits, and also showed very similar performance to the current PMT system (data for current PMT also provided in the document, which are very close), it successfully met these criteria. The method comparison's strong correlation, slope near 1, and intercept near 0 directly support "substantially equivalent" performance.
Study Details
2. Sample size used for the test set and the data provenance
- Method Comparison Test Set Sample Size: 45 patient samples
- Precision Test Set Sample Size: 3 commercial quality controls (BioRad Liquichek Immunoassay QC - 3 levels) and 2 patient serum pools.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the studies were conducted "internally by Siemens Healthcare Diagnostic Inc. R & D organization personnel," suggesting a US or European location where Siemens R&D is prominent. Given the FDA submission, the data is likely intended to be representative for the US market.
- Retrospective or Prospective:
- Method Comparison: Retrospective. "Remnant de-identified human serum samples were tested." This implies samples were collected previously for other purposes.
- Precision: Prospective. Testing was performed "over twenty (20) days, one (1) run per day for each test material." This indicates systematic, planned testing for this study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an in vitro diagnostic (IVD) device measuring a quantitative biomarker (Free Thyroxine). The ground truth for such devices is established through laboratory methods and reference materials, not expert human interpretation (like in imaging or clinical diagnosis). The "test set" and "ground truth" here refer to the accurate measurement of FT4L concentrations.
- The "ground truth" for the comparative study is the measurement obtained from the predicate device (Dimension® EXL™ with LM system with the current PMT), which is the standard of comparison for demonstrating substantial equivalence. The study aims to show that the new device yields the same results as the predicate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None. Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation or subjective assessments (e.g., in radiology studies where multiple readers interpret images, and discrepancies need resolution). For quantitative IVD devices, analytical measurements are directly compared.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-powered diagnostic tools that assist human readers in interpreting complex data (e.g., medical images).
- This submission is for a change in a component of an automated laboratory analyzer that measures a quantitative biomarker. There is no human "reader" involved in the direct output of the Free Thyroxine measurement, nor is there AI assistance to a human for interpretation in the context of this device's function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively (for the measurement component). The device itself is an automated analyzer. The "algorithm only" performance is the measurement output by the instrument. The study directly compares the numerical results from the device with the new PMT to the device with the current PMT. There is no "human-in-the-loop" once the sample is loaded; the instrument performs the analysis automatically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Reference Method/Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence in this context is the performance of the previously cleared predicate device (Dimension® EXL™ with LM system with the original PMT). The study aims to show that the new device produces results that are statistically indistinguishable from those produced by the predicate device.
- For the precision study, commercial quality controls and patient pools with known, stable concentrations serve as the reference materials monitored for consistency.
- For traceability, "USP-grade thyroxine spiked into stripped human serum" and a "Master Pool" calibrated against an "Anchor Pool" are used for defining the FT4L values.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional in vitro diagnostic analyzer. While the instrument and assay are developed and optimized (which involves internal testing and calibration), the concept of a "training set" as understood in AI studies does not apply here.
9. How the ground truth for the training set was established
- Not Applicable. As explained above, there is no "training set" in the context of AI/ML. The device's underlying principles are based on established chemical and immunoassay reactions, not trained algorithms. The "ground truth" for calibrating the system and ensuring its accuracy is established through stringent analytical chemistry practices, including the use of reference materials, calibrators, and validation against established methods (as mentioned in the traceability section).
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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 | StreptavidinSensibeads | 225 µg/mL | Recombinant E. coli |
| 3 – 4 | Liquid | T3Chemibeads | 200 µg/mL | |
| 5 – 6 | Liquid | FT4Biotinylatedantibody | 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:Dimension® EXLTM with LMwith new PMT | Predicate:Dimension® EXLTM with LM(K073604) |
|---|---|---|
| Intended Use | The Dimension® EXLTM withLM system is an in vitrodiagnostic device that is intendedto measure a variety of analytesin human body fluids. Thesystem utilizes photometric,turbidimetric,chemiluminescence andintegrated ion selectivemultisensor technology forchemical and immunochemicalapplications for clinical use. | Same |
| Indications forUse | The Dimension® EXLTM withLM system is an in vitrodiagnostic device that is intendedto measure a variety of analytesin human body fluids. Thesystem utilizes photometric,turbidimetric,chemiluminescence andintegrated ion selectivemultisensor technology forchemical and immunochemicalapplications for clinical use. | Same |
| System Control | Fully automated and controlledby microprocessors | Same |
| User Interface | Contains graphical user interfacescreens | Same |
| DetectionTechnologies | Contains a photometer, aheterogeneous module and amultisensor electrode for | Same |
| performing photometric tests,and electrolyte tests. It also hasa LOCI® module for high-sensitivity homogenousimmunoassay 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.Reactions are controlled at 37°C. | Same |
| Operating System | LINUX Operating System | Same |
| Photomultipliertube used to countthe signal in thechemiluminescentmethods | * Contains a faceplate* Contains a photocathode* 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:Dimension® EXL™ with LMwith new PMT | Predicate:Dimension® EXL™ with LM(K073604) |
|---|---|---|
| Photomultipliertube used to countthe signal in thechemiluminescentmethods | Vendor: HamamatsuMultiplier channel: multipledynodes | Vendor: ExcelitasMultiplier channel: EnhancedGlass Single Surface Tube |
.
. . . . . . .
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| Feature | Device:Dimension® FT4L Flex®reagent cartridge | Predicate:Dimension® FT4L Flex®reagent cartridge(K073604) |
|---|---|---|
| Intended Use | The FT4L method is an invitro diagnostic test for thequantitative measurement ofFree Thyroxine in humanserum and plasma on theDimension® EXL™ withLM system. Measurementsof free thyroxine are used inthe diagnosis andmonitoring of thyroiddisease. | 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-Streptavidin sensibeads, T3Chemibeads and FT4biotinylated antibody(containing mousemonoclonal 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(ng/mL) | Slope(95% CI) | Interceptng/dL(95% CI) | CorrelationCoefficient(std linearregression) | n |
|---|---|---|---|---|---|
| FT4L(PassingBablok) | 0.23 – 7.78 | 0.99(0.96 – 1.01) | -0.03(-0.07 – 0.00) | Not applicable | 45 |
| FT4L(linearregression) | 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 targetconcentration(ng/dL) | BioRad QCEXL LOCI ModuleConcentration(ng/dL) | Repeatability(CV %) | With-in Lab(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 (800) 638-2041 or (301) 796-7100 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)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler S
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§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.