DIMERTEST

K080069 · American Diagnostica, Inc. · DAP · Feb 13, 2008 · Hematology

Device Facts

• Record ID: K080069
• Device Name: DIMERTEST
• Applicant: American Diagnostica, Inc.
• Product Code: DAP · Hematology
• Decision Date: Feb 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The DIMERTEST® latex kit is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.

Device Story

DIMERTEST® latex kit; qualitative/semi-quantitative evaluation of D-dimer in human plasma; utilizes latex beads coupled with murine anti-D-Dimer monoclonal antibody; includes positive/negative controls, buffer, test cards, and stirrers; used in clinical laboratory settings; provides visual assessment of fibrin degradation products to aid in clinical evaluation.

Clinical Evidence

No clinical data; submission is for transfer of ownership of a previously cleared device (K974596).

Technological Characteristics

Latex immuno-assay; latex beads coupled with murine anti-D-Dimer monoclonal antibody; qualitative/semi-quantitative visual test card format.

Indications for Use

Indicated for the rapid qualitative or semi-quantitative evaluation of circulating D-dimer in human plasma to assess fibrin degradation products.

Predicate Devices

• DIMERTEST® (K974596)

Submission Summary (Full Text)

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

A. 510(k) Number: K080069
B. Purpose for Submission: Transfer of ownership of 510(k)
C. Measurand: D-Dimer
D. Type of Test: Latex Immuno Assay
E. Applicant: American Diagnostica Inc.
F. Proprietary and Established Names: DIMERTEST®
G. Regulatory Information:

1. Regulation section: 864.7320
2. Classification: II
3. Product code: DAP
4. Panel: Hematology

H. Intended Use:

1. Intended use(s): The DIMERTEST® latex kit is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
2. Indication(s) for use: same as Intended Use.
3. Special conditions for use statement(s): N/A
4. Special instrument requirements: N/A

I. Device Description:

The kit is comprised of: latex reagent (latex beads coupled with murine anti-D-Dimer monoclonal antibody), positive control, negative control, buffer, test cards, and stirrers.

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J. Substantial Equivalence Information:

1. Predicate device name(s): DIMERTEST®
2. Predicate K number(s): K974596
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 510(k) | Same as predicate | K974596 |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 510(k) | No differences | K974596 |

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

L. Test Principle: see K974596

M. Performance Characteristics (if/when applicable):

1. Analytical performance: see K974596
a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
d. Detection limit:
e. Analytical specificity:
f. Assay cut-off:

2. Comparison studies: see K974596
a. Method comparison with predicate device:
b. Matrix comparison:

3. Clinical studies: N/A
a. Clinical Sensitivity:

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b. Clinical specificity:

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

4. Clinical cut-off: see K974596

5. Expected values/Reference range: see K974596

N. Proposed Labeling: see K974596

O. Conclusion:

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