← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K070552

# DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) (K070552)

_Dade Behring, Inc. · JIT · Apr 30, 2007 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070552

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Apr 30, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The FERR method is an in-vitro diagnostic test for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin and EDTA) on the Dimension Vista™ system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR) method on the Dimension Vista™ system.

## Device Story

Dimension Vista™ Ferritin Flex® reagent cartridge is a homogenous, sandwich chemiluminescent immunoassay using LOCI™ technology. Input: human serum or plasma sample (2 µL). Process: sample incubated with biotinylated anti-ferritin antibody and Chemibeads (coated with anti-ferritin antibody and chemiluminescent dye); Sensibeads (streptavidin-coated with photosensitizer dye) added to form bead-pair immunocomplexes. Illumination at 680 nm triggers singlet oxygen diffusion from Sensibeads to Chemibeads, inducing chemiluminescence measured at 612 nm. Output: ferritin concentration. Used in clinical laboratory settings by trained technicians. Output aids clinicians in diagnosing iron metabolism diseases. Benefits include rapid, automated quantitative assessment of ferritin levels.

## Clinical Evidence

Clinical performance established via split-sample method comparison between the subject device and the predicate. Study included 158 clinical patient samples. Results showed a correlation coefficient (r) of 0.996, a slope of 1.01, and an intercept of 1.48 ng/mL, confirming substantial equivalence.

## Technological Characteristics

Sandwich chemiluminescent immunoassay (LOCI™ technology). Reagents: synthetic bead reagents (Sensibeads, Chemibeads) and biotinylated monoclonal antibody fragments. Detection: 680 nm excitation, 612 nm emission. Matrix: bovine serum albumin. Calibrator: 5-level liquid, traceable to WHO standard 3rd IS 94/572. Automated clinical chemistry system platform.

## Regulatory Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- Ferritin (FERR) Flex® reagent cartridge for the Dimension® clinical chemistry system ([K963498](/device/K963498.md))
- Dimension FERR Calibrator ([K983548](/device/K983548.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k070552

B. Purpose for Submission:
New Device

C. Analyte:
Ferritin

D. Type of Test:
Semi-quantitative, Chemiluminescence

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ (FERR) Flex® reagent cartridge
Dimension Vista™ LOCI 4 Calibrator

G. Regulatory Information:

1. Regulation section:
21CFR §866.5340 Ferritin immunological test system
21CFR §862.1150 Calibrator

2. Classification:
Class II

3. Product Code:
DBF-Ferritin, antigen, antiserum, control
JIT-Calibrator, secondary

4. Panel:
Immunology (82)
Chemistry (75)

H. Intended Use:

1. Intended use(s):
Dimension Vista™ (FERR) Flex® reagent cartridge- The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (Iron overload) and iron deficiency anemia.

The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™.

2. Indication(s) for use:
Same as intended use.

3. Special condition for use statement(s):
Prescription use only

4. Special instrument Requirements:

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Dimension Vista® System

I. Device Description:

Dimension Vista™ FERR Flex® reagent cartridge assay is a homogeneous, sandwich chemiluminescent immunoassay using LOCI™ reagents: Sensibeads (bead reagent coated with streptavidin and containing a photosensitizer dye), Chemibeads (bead reagent coated with murine anti-ferritin monoclonal antibody and containing a chemiluminescent dye), and a biotinylated murine anti-ferritin monoclonal antibody fragment. Buffers, preservatives and stabilizers are also included in the cartridge.

Dimension Vista™ LOCI 4 Calibrator is a five level, liquid calibrator kit consisting of 10 vials (two vials for each level). The product matrix is 6% bovine serum albumin with buffer, stabilizer, and preservatives. Levels A through E contains ferritin at the following target concentrations: A~0 ng/mL, B~26 ng/mL, C~210 ng/mL, D~1050 ng/mL, E~2000 ng/mL.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension® Ferritin Flex® reagent cartridge
Dimension® Ferritin calibrator

2. Predicate K number(s):
k963498
k983548

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Dimension Vista™ Ferritin Flex ® reagent cartridge (K6440) | Dimension® Ferritin Flex® reagent cartridge (RF440)  |
|  Intended Use | The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. | The Ferritin Flex® reagent cartridge used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure ferritin in serum and heparinized plasma.  |
|  Indications for Use | Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (Iron overload) and iron deficiency anemia. | Same  |
|  Measurement type | Quantitative | Same  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Dimension Vista™ Ferritin Flex ® reagent cartridge (K6440) | Dimension® Ferritin Flex® reagent cartridge (RF440)  |
|  Capture antibody | Mouse monoclonal | Same  |
|  Reference intervals | Males 26-388 ng/mL
Females 8-252 ng/mL
All adults 8-388 ng/mL | Same  |
|  Stability: Sealed & On-board | 30 days | Same  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Instrument | Dimension Vista ® System | Dimension® Clinical Chemistry System  |
|  Solid phase | Chemibeads and Sensibeads | Ferritin antibody coated chromium dioxide particles  |
|  Conjugate reagent | None | β galactosidase labeled anti-ferritin monoclonal antibody  |
|  Substrate | None | Chlorophenol red-β-d-galactopyranoside  |
|  Detection method | Chemiluminescence | Colorimetric  |
|  Measurement absorbance | 680 and 612 nm | 577 and 700 nm  |
|  Sample type | Serum, heparinized and EDTA plasma | Serum, heparinized plasma  |
|  Sample size | 2 μL | 40 μL  |
|  Measuring Range | 0.5 ng/mL- 2000 ng/mL | 1-1000 ng/mL  |
|  Stability: Open | 7 days for wells 1-12 | Varies from 3-10 days  |
|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Dimension Vista™ LOCI 4 Calibrator | Dimension ® Ferritin Calibrator  |
|  Intended Use | To calibrate the ferritin method | Same  |
|  Composition | Ferritin from human liver in bovine serum albumin | Same  |
|  Reagent Preparation | Liquid, Ready-to-use | Same  |
|  Traceability | WHO, 3rdIS 94/572 | Same  |
|  Levels | 1 without ferritin, 4 with different concentrations of ferritin | Same  |

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|  Stability | 30 days at 2-8°C | Same  |
| --- | --- | --- |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Analytes | Multi-analyte | Ferritin  |
|  Instrument system | Dimension Vista ® System | Dimension® Clinical Chemistry System  |
|  Storage | Frozen -10 to -20°C | Refrigerated -2 to-8°C  |

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

CLSI Evaluation of Precision Performance of Clinical Devices; Approved Guideline: EP5-A2, CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline EP9-A2, CLSI Interference Testing in Clinical Chemistry; Approved Guideline EP7-A2. CLSI Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline EP6-A.

## L. Test Principle:

The FERR method is a homogenous, sandwich chemiluminescent immunoassay. Ferritin in a sample is incubated with biotinylated murine monoclonal and beads that are coated with anti-ferritin mouse monoclonal and containing a chemiluminescent dye (Chemibeads) to form a particle/ferritin/biotin-antibody sandwich. A second set of beads (Sensibeads), coated with streptavidin and containing a photosensitizer dye is added and bind to the biotin to form bead-pair immunocomplexes. The sample is illuminated at 680nm, generating a single oxygen from the Sensibeads that diffuses into the Chemibeads and triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct indication of the ferritin concentration in the sample.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Precision testing was done in accordance with CLSI Approved Guideline EP5-A2. Three serum pools and one plasma sample representing the measuring range were analyzed in duplicate, twice a day, for 20 days. Two commercially available controls were also evaluated. The standard deviation (SD) and coefficient of variation (%CV) for repeatability and within-lab precision are reported below. Overall repeatability was greater than 98% and within-lab reproducibility was greater than 96%.

|   | Mean (ng/mL) | Repeatability |   | Within-lab  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD | %CV | SD | %CV  |
|  Anemia Control Level 1 | 6.2 | 0.11 | 1.7 | 0.24 | 3.8  |
|  Control Level 2 | 161.1 | 2.02 | 1.3 | 3.72 | 2.3  |
|  Serum Pool 1 | 8.8 | 0.16 | 1.8 | 0.31 | 3.5  |
|  Serum Pool 2 | 436.4 | 5.58 | 1.3 | 14.33 | 3.3  |
|  Serum Pool 3 | 1696.3 | 27.18 | 1.6 | 57.44 | 3.4  |
|  Plasma Pool | 9.0 | 0.16 | 1.8 | 0.28 | 3.1  |

#### b. Linearity/assay reportable range:

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The linear range of the assay (0.5 – 2000 ng/mL) was confirmed by testing five replicates of each dilution (7 total) prepared from a patient serum sample, as described in CLSI protocol EP-6-A. Ferritin concentrations in the sample ranged from 0.0 to 2136.6 ng/mL. The mean of the observed values for each dilution were plotted versus the expected values. Least squares regression analysis generated the following data:

|  Slope | Y-intercept (ng/mL) | Correlation Coefficient | n  |
| --- | --- | --- | --- |
|  1.00 | 2.1 ng/mL | 1.00 | 35  |

Recovery studies were also performed using six serum samples with ferritin concentrations ranging from 4.5 - 151 ng/mL. Samples were spiked with 10 ng/mL of ferritin. The percent recovery ranged from 87% to 104% with a mean recovery of 95%.

c. Traceability (controls, calibrators, or method):
Value assignments for the calibrators are made from a master pool that is referenced to the WHO standard for ferritin 3rd IS 94/572.

d. Detection limit:
The limit of blank was determined from the mean of 20 replicates of the zero-level calibrator plus 2 standard deviations. The value obtained was 0.13 ng/mL. The limit of blank claim is 0.5 ng/mL.

e. Analytical specificity:
i. Interference studies: Interference testing was performed according to CLSI Approved Guideline EP7-A2 to determine the effect of various exogenous substances of the Dimension Vista™ FERR method. Minimal interference (<10%) was observed when pooled human serum samples representing two concentrations of ferritin (20 ng/mL and 502.7 ng/mL) containing the following interferents were compared to a control without interferent: hemoglobin (500 mg/dL), unconjugated bilirubin (20 mg/dL), conjugated bilirubin (60 mg/dL), Intralipid (3000 mg/dL) rheumatoid factor (510 IU/mL). An additional panel of 41 exogenous substances were evaluated for interference and were shown to exhibit minimal interference (<10%).

ii. Cross-reactivity
Not applicable.

iii. Antigen excess- The effect of antigen excess in the Dimension Vista™ FERR assay was evaluated using the zero-level calibrator spiked with 250,000 ng/mL of human ferritin. The test result was reported as “exceeds assay range.” Samples greater than 2000 ng/mL are reported as exceeding assay range.

f. Assay cut-off:
See Expected values/reference range.

2. Comparison studies:
a. Method comparison with predicate device:

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CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2 was followed. The Dimension Vista™ FERR method on the Dimension Vista™ System was compared to the predicate Dimension® Ferritin Flex® reagent cartridge on the Dimension® RxL instrument by assaying 158 serum samples with concentrations ranging from 4.4 ng/mL to 1573.3 ng/mL on both systems and comparing the results. Ordinary least squares linear regression statistics are as follows:

|  Comparative Method | Slope | Y-Intercept (ng/mL) | Correlation coefficient (r) | N  |
| --- | --- | --- | --- | --- |
|  Dimension RxL System | 1.01 | 1.48ng/mL | 0.996 | 158  |

Passing-Bablok non-parametric linear regression analysis yielded the following statistics: Slope 1.02 (95% CI: 1.00 to 1.03), Y-intercept -0.95 (95% CI -1.81 to -0.47).

b. Matrix comparison:

Ten matched serum, Na-heparin plasma, Li-heparin plasma, EDTA-plasma samples containing ferritin concentrations ranging 5.3 -1978.5 ng/mL, were assayed and compared. Least squared regression analysis demonstrated that there was no significant bias between the two matrices and yielded the following statistics:

|  Sample type compared to serum | Slope | Y-intercept | Correlation coefficient  |
| --- | --- | --- | --- |
|  Na-heparin plasma | 1.03 | -2.1 | 1.00  |
|  Li-heparin plasma | 1.01 | -4.0 | 1.00  |
|  EDTA-plasma 1.00 | 1.00 | -4.6 | 1.00  |

3. Clinical studies:

a. Clinical sensitivity: Not applicable.
b. Clinical specificity: Not applicable.
c. Other clinical supportive data (when a and b are not applicable): Not applicable.

4. Clinical cut-off: See Expected values/reference range

5. Expected values/Reference range:

The reference intervals were transferred from those previously obtained using the predicate Dimension® system. They represent the central 95% of results determined from a population of healthy adults (n=296; 118 males, and 178 females). The original determination and transference were done in accordance with protocol CLSI C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory. Pediatric samples were not evaluated.

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|  Sample | 95% Reference Interval  |
| --- | --- |
|  Males | 26-388 ng/mL  |
|  Females | 8-252 ng/mL  |
|  All adults | 8-388 ng/mL  |

# 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070552](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070552)

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