VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442

K030328 · bioMerieux, Inc. · DAP · Sep 2, 2003 · Hematology

Device Facts

• Record ID: K030328
• Device Name: VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
• Applicant: bioMerieux, Inc.
• Product Code: DAP · Hematology
• Decision Date: Sep 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The VIDAS®D-Dimer New is an automated, quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the D-dimer domain in citrated human plasma using the Enzyme Linked Fluorescent Assay (ELFA) technique. The VIDAS®D-Dimer New is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) in outpatients suspected of DVT.

Device Story

Automated, quantitative immunoassay for D-dimer in citrated human plasma; utilizes Enzyme Linked Fluorescent Assay (ELFA) technique on VIDAS analyzer. Device uses Solid Phase Receptacle (SPR) as both solid phase and pipettor; reagents pre-dispensed in sealed strips. Instrument controls all assay steps and temperatures. Used in clinical laboratory settings; operated by laboratory personnel. Output is quantitative D-dimer concentration (ng FEU/ml). Healthcare providers use output in conjunction with clinical pretest probability (PTP) assessment to exclude DVT in suspected outpatients. Benefit is rapid, automated exclusion of DVT, reducing need for further diagnostic imaging.

Clinical Evidence

Prospective cohort study of 556 outpatients with suspected DVT. Patients classified by Wells PTP model (low, moderate, high). Assay performance at 500 ng FEU/ml cutoff: Sensitivity 100% (93.6-100.0), Specificity 32.9% (28.8-37.2), Negative Predictive Value 100% (97.8-100.0). Results demonstrate high sensitivity and NPV across all PTP groups, supporting the device's utility in excluding DVT.

Technological Characteristics

Automated quantitative ELFA; uses Solid Phase Receptacle (SPR) for sample processing and pipetting. Reagents are pre-dispensed in sealed strips. Operates on VIDAS analyzer. Analytical range 45–10,000 ng FEU/ml; cut-off 500 ng FEU/ml. Detection limit 45 ng FEU/ml.

Indications for Use

Indicated for use in conjunction with clinical pretest probability (PTP) assessment to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

Predicate Devices

• VIDAS D-Dimer (DD) New Assay, K020810

Submission Summary (Full Text)

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

A. 510(k) Number:
K030328

B. Analyte:
D-Dimer

C. Type of Test:
Quantitative, enzyme-linked fluorescent Immunoassay

D. Applicant:
bioMerieux, Inc.

E. Proprietary and Established Names:
VIDAS D-DIMER NEW (DD2) ASSAY

F. Regulatory Information:
1. Regulation section:
21 CRD 864.7320
2. Classification:
Class II
3. Product Code:
DAP
4. Panel:
81 Hematology

G. Intended Use:
1. Indication(s) for use:
The VIDAS®D-Dimer New is an automated, quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the D-dimer domain in citrated human plasma using the Enzyme Linked Fluorescent Assay (ELFA) technique.
2. Special condition for use statement(s):
The VIDAS®D-Dimer New is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) in outpatients suspected of DVT.

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3. Special instrument Requirements:

The VIDAS®D-Dimer New is intended for use on the VIDAS analyzer

H. Device Description:

The VIDAS®D-Dimer New (DD2) is an automated, quantitative test for d-dimer, intended for use on the VIDAS analyzer (K891385). Fibrin degradation products (FbDP) in human plasma are determined using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.

I. Substantial Equivalence Information:

1. Predicate device name(s): VIDAS D-Dimer (DD) New Assay
2. Predicate K number(s): K020810
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample requirements | Citrated plasma | Same |
| Differences | | |
| Item | Device | Predicate |
| Indications for use | To exclude DVT in conjunction with a PTP | Aid in diagnosis of DVT and PE |

J. Standard/Guidance Document Referenced (if applicable):

K. Test Principle:

enzyme-linked fluorescent immunoassay (ELFA)

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

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| | | | Within-run Precision | Total Precision |
| --- | --- | --- | --- | --- |
| Plasma | N | Conc. (ng FEU/ml) | CV (%) | CV (%) |
| Level 1 | 80 | 264 | 5.0 | 5.7 |
| Level 2 | 80 | 549 | 3.9 | 5.8 |
| Level 3 | 80 | 7283 | 5.3 | 7.1 |

b. Linearity/assay reportable range: 45 – 10,000 ng FEU/ml

c. Traceability (controls, calibrators, or method):

d. Detection limit: 45 ng FEU/ml

e. Analytical specificity:

f. Assay cut-off: 500 ng FEU/ml

2. Comparison studies:

a. Method comparison with predicate device:

b. Matrix comparison:

3. Clinical studies:

a. Clinical sensitivity: 100% (95% CI, 95.0-100)

b. Clinical specificity: 33% (95% CI, 27.0-39.1)

c. Other clinical supportive data (when a and b are not applicable): Negative predictive value 100% (95% CI, 95.3-100)

4. Clinical cut-off: 500 ng FEU/ml

5. Expected values/Reference range: <500 ng FEU/ml

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| Patients | N | %Clinical Sensitivity (95% CI) | %Clinical Specificity (95% CI) | %Negative Predictive Value (95% CI) |
| --- | --- | --- | --- | --- |
| Suspected DVT With Low PTP | 295 | 100.0 (18/18) (81.5-100.0) | 39.7 (110/277) (33.8-45.7) | 100.0 (110/110) (96.7-100.0) |
| Suspected DVT With Moderate PTP | 189 | 100.0 (17/17) (80.5-100.0) | 26.7 (46/172) (20.3-34.0) | 100.0 (46/46) (92.3-100.0) |
| Suspected DVT with High PTP | 71 | 100.0 (21/21) (83.9-100.0) | 18.0 (8/50) (7.2-29.1) | 100.0 (8/8) (83.1-100.0) |

**M. Conclusion:**

Data has demonstrated that this device is substantially equivalent to a legally marketed device.