ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS

K033491 · Roche Diagnostics Corp. · DAP · Sep 1, 2004 · Hematology

Device Facts

• Record ID: K033491
• Device Name: ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
• Applicant: Roche Diagnostics Corp.
• Product Code: DAP · Hematology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The Roche CARDIAC D-Dimer Assay is intended for the quantitative determination of D-Dimer in anticoagulated venous whole blood with the CARDIAC reader instrument.

Device Story

The CARDIAC D-Dimer Assay is a point-of-care diagnostic test for quantitative D-Dimer measurement. It utilizes a test strip with a sample application well and a lot-specific coding chip. The user applies anticoagulated venous whole blood to the strip; red cells are separated from plasma on-strip. A monoclonal antibody sandwich complex forms, binding to a streptavidin band in the detection zone, where a gold-labelled antibody produces a color signal. The CARDIAC reader instrument measures this signal intensity, which correlates to D-Dimer concentration. The output is a quantitative result used by clinicians to aid in the assessment of thromboembolic venous diseases. The device is intended for use in clinical settings, including point-of-care environments.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing comparing the Cardiac D-Dimer Assay to the predicate Tina-quant® D-Dimer Test System.

Technological Characteristics

Quantitative immunoassay; dual monoclonal antibody sandwich principle; poly-streptavidin-biotin capture system; gold sol particle label. Form factor: test strip in plastic casing with lot-specific coding chip. Requires CARDIAC Reader instrument for signal quantification. Measuring range: 0.1 – 4.0 ug/mL. Sample type: anticoagulated venous whole blood.

Indications for Use

Indicated for the quantitative determination of d-dimer in anticoagulated venous whole blood to measure fibrinolytic activity. Useful in ruling out deep venous thrombosis or pulmonary embolism.

Predicate Devices

• Tina-quant® D-Dimer Test System (K002706)

Submission Summary (Full Text)

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

A. 510(k) Number:
#K033491

B. Purpose for Submission:
New device

C. Analyte:
D-Dimer

D. Type of Test:
Quantitative

E. Applicant:
Roche Diagnostics Corporation

F. Proprietary and Established Names:
CARDIAC D-Dimer Assay; Fibrin Split Products, Antigen, antiserum, Control

G. Regulatory Information:
1. Regulation section:
CFR Section 864.7320 - Fibrin Degradation Products Assay
2. Classification:
Class II
3. Product Code:
DAP; GHH
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use(s):
The Roche CARDIAC D-Dimer Assay is intended for the quantitative determination of D-Dimer in anticoagulated venous whole blood with the CARDIAC reader instrument.
2. Indication(s) for use:
Same as the Intended Use.
3. Special condition for use statement(s):
N/A
4. Special instrument Requirements:
Roche Diagnostics Corp. CARDIAC Reader (#K000784)

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I. Device Description:

The CARDIAC D-Dimer Assay consists of a test strip in plastic casing, with a well for sample application; viewing window at the detection zone; a lot-specific coding chip for each batch of test strips; and Control, Levels I/II. Testing is initiated by the addition of whole blood to the test strip, where red cells are separated from the plasma. A monoclonal antibody (MAB) sandwich complex is formed and bound to a streptavidin band in the detection zone, where the gold-labelled antibody forms a reddish-purple color signal. That signal is determined by the CARDIAC reader.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Roche Diagnostics Corp. Tina-quant® D-Dimer Test System
2. Predicate K number(s):
#K002706
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample anticoagulant | Heparin | Same |
| Assay type | Quantitative immunoassay that utilizes mouse MAB’s | Same |
| Reagents | Includes buffer | Same |
| Differences | | |
| Item | Device | Predicate |
| Sample type | Heparinized plasma separated from venous whole blood during the test procedure | Pre-prepared citrated or heparinized plasma |
| Principle | Sandwich assay with color indicator | Turbidometric latex assay |
| Reagents | Biotinylated and gold-labelled anti-D-Dimer antibody | Latex particles coated with anti-human D-Dimer MAB |
| Measuring range | 0.1 – 4.0 ug/mL | 0.15 – 9.0 ug/mL |

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

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L. Test Principle:

The Roche CARDIAC D-Dimer Assay is an immunoassay based upon the dual monoclonal antibody (MAB) sandwich principle. It uses a poly-streptavidin-biotin capture system with a gold sol particle label. D-Dimer in the sample combines with the antibodies conjugated to the gold sol particles to form a "sandwich". This, in turn, combines with the poly-streptavidin-biotin, which is immobilized in a line across the result window. The speed and intensity of color formation is related to the concentration of D-Dimer in the sample; and results are determined on the CARDIAC Reader instrument.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

(2) to (3) lots of Levels I/II quality control were run at each site. Within-run – performed at (4) sites and run X (10) on each analyzer. Level I %CV’s ranged 7.8 – 14%. Level II %CV’s ranged 8.0 – 18%.

Day-to-day – performed at (2) sites, over 20 - 36 days on each analyzer. Level I %CV’s ranged 12.3 – 14%. Level II %CV’s ranged 10.5 – 17.1%.

Acceptance criteria: ≤ 20%

b. Linearity/assay reportable range:

0.1 – 4 mg/L, determined from method comparison data.

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

Calibrated to the Roche Tina-quant D-Dimer method by using a primal master lot to establish a calibration curve.

d. Detection limit:

0.1 mg/L

e. Analytical specificity:

Various levels of D-Dimer tested for endogenous substances (hematocrit, hemoglobin, bilirubin, lipids, and HAMA); and exogenous substances (biotin, heparin, Vitamin C, aspirin and prescription drugs). Fibrinogen and fragments D, E, X and Y were also tested. Rheumatoid factor was not tested.

f. Assay cut-off:

N/A

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2. Comparison studies:

a. Method comparison with predicate device:

Performed at (6) clinical sites, including (5) point-of-care (POC) sites. Studies were done on patients suspected of thromboembolic venous diseases, peri- or post-OR patients and healthy donors. Three lots of CARDIAC test strips were run against the Tina-quant assay. The following regression data were obtained:

Lot 1, (6) sites - (N = 464); y = -0.04 + 1.09x; r = 0.89
Lot 2, (6) sites - (N = 463); y = -0.02 + 1.08x; r = 0.90
Lot 3, (4) sites - (N = 92); y = -0.02 + 1.30x; r = 0.90

b. Matrix comparison:

Ammonium and lithium heparins were tested on samples (N = 164) with the CARDIAC and Tina-quant D-Dimer assays. Regression data: y = 0.02 + 1.118x; r = 0.908.

3. Clinical studies:

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

4. Clinical cut-off: N/A

5. Expected values/Reference range:

A normal range study was performed on normal individuals (N = 130), consisting of 93 females and 37 males, ranging in age from 19 - 94 years. The mean value was 0.50 mg/L.

N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.