← Product Code [GHH](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH) · K062203

# TINA-QUANT D-DIMER TEST SYSTEM (K062203)

_Roche Diagnostics Corp. · GHH · Mar 14, 2007 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K062203

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [GHH](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH.md)
- **Decision Date:** Mar 14, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7320
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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).

## Predicate Devices

- Tina-Quant D-Dimer Test System ([K030740](/device/K030740.md))
- Biomerieux Vidas D-Dimer Exclusion Assay ([K040822](/device/K040822.md))

## 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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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K062203](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K062203)

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