DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

K090236 · Siemens Healthcare Diagnostics · LOJ · Apr 27, 2009 · Immunology

Device Facts

• Record ID: K090236
• Device Name: DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
• Applicant: Siemens Healthcare Diagnostics
• Product Code: LOJ · Immunology
• Decision Date: Apr 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

The AFP method is an in vitro diagnostic test for the quantitative measurement of alphafetoprotein in human serum and lithium heparin plasma on the Dimension Vista® System. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.

Device Story

Dimension Vista® AFP Flex® reagent cartridge is an in vitro diagnostic immunoassay for quantitative measurement of alpha-fetoprotein (AFP) in human serum and lithium heparin plasma. Device utilizes LOCI® (Luminescent Oxygen Channeling Immunoassay) technology; a homogeneous, sandwich chemiluminescent immunoassay. Input: 2 uL patient sample. Process: Sample incubated with biotinylated anti-AFP antibody and Chemibeads (anti-AFP antibody-coated, chemiluminescent dye-containing); Sensibeads (streptavidin-coated, photosensitizer dye-containing) added to form bead-pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads, diffusing to Chemibeads to trigger chemiluminescence. Output: Signal measured at 612 nm, proportional to AFP concentration. Used in clinical laboratory settings on the Dimension Vista® System. Results assist clinicians in managing non-seminomatous testicular cancer alongside physical exams and histology/pathology.

Clinical Evidence

No clinical studies were performed. Evidence is based on analytical performance and matrix comparison. Matrix comparison study (N=70) compared matched serum and lithium heparinized plasma samples, yielding a correlation coefficient of 0.997 and a slope of 0.99 (95% CI: 0.96-1.00). Precision studies conducted per CLSI EP5-A2 showed repeatability CVs of 1.0-1.2% and within-lab CVs of 1.7-2.0% for plasma samples.

Technological Characteristics

Homogeneous, sandwich chemiluminescent immunoassay using LOCI® technology. Reagents: Chemibeads (anti-AFP monoclonal antibody, chemiluminescent dye) and Sensibeads (streptavidin, photosensitizer dye). Energy source: 680 nm illumination. Detection: 612 nm chemiluminescence. Sample matrix: Human serum and lithium heparinized plasma. Platform: Dimension Vista® System. Standard: CLSI/NCCLS EP5-A2.

Indications for Use

Indicated for the quantitative measurement of alpha-fetoprotein in human serum and lithium heparinized plasma as an aid in managing non-seminomatous testicular cancer in conjunction with clinical evaluation.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Dimension Vista® AFP Flex® reagent cartridge (k071597)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k090236

B. Purpose for Submission:
Adding new sample type

C. Measurand:
Alpha-Fetoprotein (AFP)

D. Type of Test:
Quantitative, Chemiluminescence

E. Applicant:
Siemens Healthcare Diagnostics, Inc.

F. Proprietary and Established Names:
Dimension Vista® AFP Flex® reagent cartridge

G. Regulatory Information:
1. Regulation section:
21 CFR 866.6010
Tumor-associated antigen immunological test system
2. Classification:
Class II
3. Product code:
LOJ Kit, Test, Alpha-fetoprotein for testicular cancer
4. Panel:
Immunology (82)

H. Intended Use:
1. Intended use(s):
Dimension Vista® AFP Method: The AFP method is an in vitro diagnostic test for the quantitative measurement of alpha-fetoprotein in human serum and lithium heparinized plasma on the Dimension Vista® system. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology and other clinical evaluation procedures.
2. Indication(s) for use:
Same as above
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
Dimension Vista® System

I. Device Description:
The Dimension Vista® AFP method consists of two synthetic bead reagents and a biotinylated murine-anti-AFP antibody. The first bead reagent (Chemibeads) is coated with an anti-AFP monoclonal antibody and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. All are supplied in liquid format in a reagent cartridge.

J. Substantial Equivalence Information:

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1. Predicate device name(s): Dimension Vista® AFP Flex® reagent cartridge
2. Predicate 510(k) number(s): k071597
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use/Indications for Use | As an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology and other clinical evaluation procedures | Same |
| Technology | Homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology | Same |
| Reagent cartridge components | Chemibeads, Sensibeads and a biotinylated murine-anti-AFP antibody in a reagent cartridge. | Same |
| Instrument platform | Dimension Vista® System | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample matrix | Human serum and lithium heparinized plasma | Human serum |

K. Standard/Guidance Document Referenced (if applicable):
CLSI/NCCLS Approved Guideline for Evaluation of Precision Performance of Quantitative Measurement Methods (EP5-A2).

L. Test Principle:
The Dimension Vista® AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-AFP monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-AFP monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-AFP-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

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AFP concentration in the sample.

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

### 1. Analytical performance:

**a. Precision/Reproducibility:**

In addition to the original precision results using serum samples, a precision study using a lithium heparinized plasma pool sample was conducted in accordance with the CLSI EP5-A2 Approved Guideline for Evaluation of Precision Performance of Quantitative Measurement Methods.

| Material | Mean ng/mL | SD (%CV) Repeatability | SD (%CV) Within-Lab |
| --- | --- | --- | --- |
| Plasma Pool | 249.0 | 2.9 (1.2) | 5.1 (2.0) |

To determine the precision at the lower end of the assay range, the sponsor provided data from a 5-day precision study using a lithium heparinized plasma pool sample with 8 ng/mL AFP. The results are summarized below.

| Material | Mean ng/mL | SD (%CV) Repeatability | SD (%CV) Within-Lab |
| --- | --- | --- | --- |
| Plasma Pool | 7.5 | 0.08 (1.0) | 0.13 (1.7) |

**b. Linearity/assay reportable range:**
Same as k071597

**c. Traceability, Stability, Expected values (controls, calibrators, or methods):**
Same as k071597

**d. Detection limit:**
Same as k071597

**e. Analytical specificity:**
Same as k071597

**f. Assay cut-off:**
Same as k071597

### 2. Comparison studies:

**a. Method comparison with predicate device:**
Not applicable.

**b. Matrix comparison:**
Matched serum and lithium (Li) heparinized plasma samples (N=70), were collected from patients and immediately frozen at -20°C. All samples were tested within 60 days from the date of collection. On the date of testing, serum and Li heparinized plasma samples were thawed at 20 - 25°C for 30 minutes and the AFP values were determined with the Dimension Vista® AFP assay. Samples above the assay range (0.5-1000 ng/mL) were manually diluted with matched normal human serum and Li heparinized plasma. Samples were run in triplicate. AFP recovery in serum versus Li heparinized plasma was compared by Passing & Bablok regression analysis.

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The range of AFP values in the correlation study was 0.9 to 999.5 ng/mL [0.7 to 825.6 IU/mL].

| Sample comparison | Slope(95% CI) | Intercept ng/mL [IU/mL] (95% CI) | Correlation Coefficient | N |
| --- | --- | --- | --- | --- |
| Lithium heparin vs. serum | 0.99(0.96 - 1.00) | -0.05 [-0.04] (-0.10 - 0.06) | 0.997 | 70 |

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: Not applicable.

5. Expected values/Reference range: Not applicable.

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.