DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
Device Facts
| Record ID | K140859 |
|---|---|
| Device Name | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | CEC · Clinical Chemistry |
| Decision Date | Nov 26, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1695 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K140859 · Nov 26, 2014 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | Siemens Healthcare Diagnostics, Inc. | Retrospective clinical patient samples | Retrospective analysis of 421 pediatric patient samples to establish and validate pediatric reference intervals for the FT4 and TSH assays. | Pediatric reference intervals; Retrospective data analysis; Clinical laboratory data |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Pediatric Reference Interval Establishment; Retrospective analysis of clinical patient samples | 421 pediatric patients (82 infants, 191 children, 148 adolescents); Sample Size: 421 | Not applicable for this study | Establishment of pediatric reference intervals for FT4 and TSH assays |
Indications for Use
The FT4 method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease. The TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista® System. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Device Story
In vitro diagnostic reagent cartridges for Dimension Vista® systems; measure Free Thyroxine (FT4) and Thyroid Stimulating Hormone (TSH) in human serum/plasma; used by clinical laboratory professionals for diagnosis/monitoring of thyroid/pituitary disorders. Device utilizes existing analytical chemistry methods; no changes to reagents or hardware. Submission adds pediatric reference intervals to labeling based on analysis of 421 pediatric patient samples. Healthcare providers use quantitative results compared against established reference intervals to assess thyroid function and guide clinical decision-making.
Clinical Evidence
No new clinical performance data required. Pediatric reference intervals were established by analyzing 421 patient samples (82 infants, 191 children, 148 adolescents) using a non-parametric approach or robust symmetric method (for infants) per CLSI EP28-A3c. Analytical performance data from predicate submissions (K053531, K060090) remains applicable.
Technological Characteristics
In vitro diagnostic reagent cartridges for use on Dimension Vista® systems. No changes to materials, sensing principles, or energy sources. Assays utilize established quantitative measurement methods for FT4 and TSH. Pediatric reference intervals added to labeling; analytical measuring ranges: FT4 (0.1-8.0 ng/dL), TSH (0.005-100 µIU/mL).
Indications for Use
Indicated for quantitative measurement of TSH and Free Thyroxine in human serum and plasma for diagnosis/treatment of thyroid or pituitary disorders in pediatric populations (infants 1-23 months, children 2-12 years, adolescents 13-20 years).
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
- Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge (k060090)
- Dimension Vista® Free Thyroxine Flex® reagent cartridge (k053531)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k140859
B. Purpose for Submission:
Adding pediatric reference ranges to previously cleared assays (cleared under k060090 and k053531)
C. Measurand:
Thyroid Stimulating Hormone (TSH)
Free Thyroxine (FT4)
D. Type of Test:
Quantitative, chemiluminescence immunoassay
E. Applicant:
Siemens Healthcare Diagnostics Inc.
F. Proprietary and Established Names:
Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge, TSH
Dimension Vista® Free Thyroxine Flex® reagent cartridge, FT4
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1690, Thyroid stimulating hormone test system
21 CFR §862.1695, Free Thyroxine test system
2. Classification:
Class II
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3. Product code:
JLW
CEC
4. Panel:
Clinical Chemistry (75)
H. Intended Use:
1. Intended use(s):
See Indications(s) for use below
2. Indication(s) for use:
Dimension Vista® TSH Cartridge: The TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista® System. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Dimension Vista® FT4 Cartridge: The FT4 method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension Vista® System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
Dimension Vista® System
I. Device Description:
Dimension Vista® TSH Cartridge:
The Dimension Vista® TSH Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged liquid reagents in a plastic twelve-well cartridge. The device contains the following reagents: biotinylated TSH antibody (mouse monoclonal), TSH antibody coated Chemibeads (mouse monoclonal) and streptavidin Sensibeads (recombinant).
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Dimension Vista® FT4 Cartridge:
The Dimension Vista® FT4 Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged liquid reagents in a plastic twelve-well cartridge. The device contains the following reagents: liquid streptavidin Sensibeads (recombinant), liquid T3 Chemibeads and liquid FT4 biotinylated antibody (mouse monoclonal).
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Dimension Vista® TSH Cartridge: Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge
Dimension Vista® FT4 Cartridge: Dimension Vista® Free Thyroxine Flex® reagent cartridge
2. Predicate 510(k) number(s):
Dimension Vista® TSH Cartridge: k060090
Dimension Vista® FT4 Cartridge: k053531
3. Comparison with predicate:
Dimension Vista® TSH Cartridge:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge (k060090) |
| Intended Use | The TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista® System. | Same |
| Reagents | Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge | Same |
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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device
Dimension Vista® Thyroid Stimulating Hormone Flex® reagent cartridge (k060090) |
| Instruments | Dimension Vista® 500, 1000T, 1500 and 3000T systems | Same |
| Analytical Measuring Range (Assay Range) | 0.005 – 100 μIU/mL | Same |
| Adult Reference Intervals | 0.358 – 3.74 μIU/mL | Same |
| Pediatric Reference Ranges | Infants (01 – 23 months)
0.816 – 5.91 μIU/mL
Children (02 – 12 years)
0.662 - 3.90 μIU/mL
Adolescents (13 – 20 years)
0.463 - 3.98 μIU/mL | None |
Dimension Vista® FT4 Cartridge:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device
Dimension Vista® Free Thyroxine Flex® reagent cartridge (k053531) |
| Intended Use | The FT4 method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension Vista® System. | Same |
| Reagents | Dimension Vista® Free Thyroxine Flex® reagent cartridge | Same |
| Instruments | Dimension Vista® 500, 1000T, 1500 and 3000T systems | Same |
| Analytical Measuring Range (Assay Range) | 0.1 – 8.0 ng/dL | Same |
| Adult Reference Intervals | 0.76 – 1.46 ng/dL | Same |
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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device Dimension Vista® Free Thyroxine Flex® reagent cartridge (k053531) |
| Pediatric Reference Ranges | Infants (01 – 23 months)
0.88 - 1.48 ng/dL
Children (02 – 12 years)
0.81 - 1.35 ng/dL
Adolescents (13 – 20 years)
0.78 - 1.33 ng/dL | None |
## K. Standard/Guidance Document Referenced (if applicable):
Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline -- Third Edition (CLSI C28-A3c).
## L. Test Principle:
Dimension Vista® TSH Cartridge: The TSH method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-TSH monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti- TSH monoclonal antibody and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-TSH-biotinylated antibody sandwiches. Sensibeads are 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 a direct function of the TSH concentration in the sample.
Dimension Vista® FT4 Cartridge: The FT4 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 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. 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.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Provided in k060090 and k053531.
b. Linearity/assay reportable range:
Provided in k060090 and k053531.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Provided in k060090 and k053531.
d. Detection limit:
Provided in k060090 and k053531.
e. Analytical specificity:
Provided in k060090 and k053531.
f. Assay cut-off:
Provided in k060090 and k053531.
2. Comparison studies:
a. Method comparison with predicate device:
Provided in k060090 and k053531.
b. Matrix comparison:
Provided in k060090 and k053531.
3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
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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:
Serum samples were collected at 8 US sites to be representative of the US population diversity. Data from a total of 421 patients (82 infants, 191 children, and 148 adolescents) were analyzed on one Dimension Vista 1500 instrument to establish the Dimension Vista FT4 and TSH assay reference ranges for the studied pediatric population. Two lots of each cartridge type were used in these studies. Results from the 2.5th to 97.5th percentile were used as the pediatric reference range.
The TSH reference interval for the infant group was calculated by performing a log-transformation of the raw data followed by the application of the robust symmetric method to the transformed data. This approach was selected to be most appropriate for the smaller sample size as the data from this population was highly skewed to the right and a transformation was necessary to obtain a normal distribution. The sponsor has added language to their package insert explaining the uncertainty in the value for the upper limit of the reference range. A non-parametric approach was used to establish the reference intervals for children and adolescents.
| Age Range | Reference Ranges |
| --- | --- |
| Infants (01 – 23 months) | 0.816 - 5.91 μIU/mL |
| Children (02 – 12 years) | 0.662 - 3.90 μIU/mL |
| Adolescents (13 – 20 years) | 0.463 - 3.98 μIU/mL |
Confidence intervals for the limits of the infant reference range are as follows:
| | Lower Limit of reference range | Upper Limit of reference range |
| --- | --- | --- |
| 90% confidence intervals: | 0.683 - 0.962 μIU/mL | 5.06 - 7.09 μIU/mL |
The FT4 reference interval for the infant group was calculated using the robust symmetric method to accommodate the smaller sample size of this population. A non-parametric approach was used to establish the reference intervals for children and adolescents.
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| Age Range | Reference Ranges |
| --- | --- |
| Infants (01 – 23 months) | 0.88 - 1.48 ng/dL |
| Children (02 – 12 years) | 0.81 - 1.35 ng/dL |
| Adolescents (13 – 20 years) | 0.78 - 1.33 ng/dL |
Confidence intervals for the limits of the infant reference range are as follows:
| | Lower Limit of reference range | Upper Limit of reference range |
| --- | --- | --- |
| 90% confidence intervals: | 0.82 – 0.95 ng/dL | 1.42 – 1.53 ng/dL |
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.
