TINA-QUANT D-DIMER TEST SYSTEM

K062203 · Roche Diagnostics Corp. · GHH · Mar 14, 2007 · Hematology

Device Facts

• Record ID: K062203
• Device Name: TINA-QUANT D-DIMER TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: GHH · Hematology
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The Roche diagnostics Tina-Quant D-dimer assay is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including d-dimer and x-oligomers in human plasma. In conjunction with a non-high clinical probability assessment, a normal (<0.5 µg FEU/mL) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.

Device Story

Tina-Quant D-dimer is an immunoturbidimetric assay for quantitative measurement of fibrin degradation products (D-dimer/x-oligomers) in human plasma. Device utilizes latex particles coated with monoclonal anti-D-dimer antibodies (F(ab')2 fragments). Sample addition triggers antigen-antibody complex formation, increasing turbidity measured by Roche automated clinical chemistry analyzers. Used in clinical laboratory settings to assist clinicians in excluding DVT and PE in patients with non-high pre-test probability. Results below 0.5 µg FEU/mL threshold, combined with clinical assessment, allow for exclusion of DVT/PE, reducing need for further diagnostic imaging.

Clinical Evidence

Clinical performance supported by two management studies. DVT study (n=812): patients with non-high pre-test probability and negative D-Dimer (<0.5 µg FEU/mL) followed for 3 months; 99.3% sensitivity, 99.4% NPV, 0.6% failure rate. PE study (n=168): patients with non-high pre-test probability and negative D-Dimer followed for 3 months; 100% sensitivity, 100% NPV, 0% failure rate.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay. Reagents: latex particles (0.15%) coated with monoclonal anti-D-Dimer F(ab')2 fragments in pH 7.2 buffer. Energy source: optical (turbidimetric measurement). Analyzers: Roche Hitachi and COBAS Integra families. Standardization: Asserachrom D-Dimer method. Measuring range: 0.15-9.0 µg FEU/mL (extendable via dilution).

Indications for Use

Indicated for patients with suspected deep vein thrombosis (DVT) or pulmonary embolism (PE) to aid in exclusion of these conditions when used in conjunction with a non-high clinical pre-test probability assessment.

Predicate Devices

• Tina-Quant D-Dimer Test System (K030740)
• Biomerieux Vidas D-Dimer Exclusion Assay (K040822)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K062203

B. Purpose for Submission:
Modification to the intended use and reagent formulation (a pH change of a buffer)

C. Measurand:
D-dimer

D. Type of Test:
Immunoturbidimetric

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Tina-Quant D-dimer

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7320
2. Classification:
Class II
3. Product code:
GHH
4. Panel:
81 Hematology

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H. Intended Use:

1. Intended use(s):

The Roche diagnostics Tina-Quant D-dimer assay is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including d-dimer and x-oligomers in human plasma. In conjunction with a non-high clinical probability assessment, a normal (&lt;0.5 µg FEU/mL) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:

Roche automated clinical chemistry analyzers

I. Device Description:

The Roche Tina-quant D-dimer is an immunoturbidimetric assay consisting of a ready to use tris buffer and a ready to use anti-d-dimer latex suspension.

J. Substantial Equivalence Information:

1. Predicate device name(s):

a. Roche Diagnostics Tina-Quant D-Dimer Test System
b. Biomerieux Vidas D-Dimer Exclusion Assay

2. Predicate 510(k) number(s):

a. K030740
b. K040822

3. Comparison with predicate:

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| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate (a) | Predicate (b) |
| Intended Use | Quantitative d-dimer and in conjunction with PTP, exclude DVT and PE | | same |
| Quality control | Bi-level | Same | same |
| | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate (a) | Predicate (b) |
| Intended Use | Quantitative d-dimer and in conjunction with PTP, exclude DVT and PE | Quantitative d-dimer | |
| Technology | Immunoturbidimetric | Same | Enzyme Linked Fluorescent Assay |
| Sample Matrix | Citrated Plasma Lithium Heparin Plasma | Same | Citrated Plasma |
| Buffer | Anti-D-dimer latex suspension in Tris Buffer pH7.2 | Anti-D-Dimer latex suspension in Tris buffer pH 8.2 | NA |

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

# L. Test Principle:

The Tina-quant D-Dimer Test System is based on a particle enhanced immunoturbidimetric method. Latex particles of uniform size are coated with monoclonal antibodies (F(ab')2 fragments) to the D-dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-dimer lead to an increase in the turbidity of the test reactants, which can be determined

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turbidmetrically.

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

### 1. Analytical performance:

a. Precision/Reproducibility:

| Within-run | Roche/Hitachi |
| --- | --- |
| 0.19μg FEU/mL | 7.3% |
| 0.86 μg FEU/mL | 1.7% |
| 5.11 FEU/mL | 0.8% |
| | COBAS Integra |
| 0.279 μg FEU/mL | 6.9% |
| 2.88 μg FEU/mL | 1.1% |

b. Linearity/assay reportable range:

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

d. Detection limit:

Roche/Hitachi: COBAS Integra: 0.04 μg FEU/mL &lt;0.08 μg FEU/mL

e. Analytical specificity:

f. Assay cut-off:

### 2. Comparison studies: N/A

a. Method comparison with predicate device:

b. Matrix comparison:

### 3. Clinical studies:

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a. Clinical Sensitivity:

DVT Exclusion

Tina-Quant® D-dimer was used in a multicenter management study involving 812 outpatients with suspected DVT. Patient pre-test probability (PTP) was assessed following Wells probability score. Patients were classified as high (≥3) or non-high (&lt;3), and the Tina-Quant® D-dimer test was then performed using a cutoff of 0.5 μg FEU/mL. Those patients with a normal (negative) d-dimer, and a non-high pretest probability had no further diagnostic testing and were followed for 3 months for development of DVT. 1 of 176 such patients developed DVT during the follow-up period. Sensitivity, NPV and Failure rates were determined as follows:

Sensitivity: 99.3%

NPV 99.4%

Failure Rate: 0.6%

PE Exclusion

Tina-Quant® D-Dimer was used in a management study involving 168 outpatients with suspected PE. Patient pre-test probability (PTP) was assessed following Wells probability score for PE. Patients were classified as having a low, moderate, or high pretest probability of PE, and the Tina-Quant® D-dimer test was then performed using a cutoff of 0.5 μg FEU/mL. Those patients with a normal (negative) d-dimer, and a non-high (low or moderate) pretest probability had no further diagnostic testing and were followed for 3 months for development of PE. No patients developed PE during the follow-up period. Sensitivity, NPV and Failure rates were determined as follows:

Sensitivity: 100%

NPV 100%

Failure Rate: 0%

b. Clinical specificity:

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

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4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

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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