← Product Code [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP) · K080069

# DIMERTEST (K080069)

_American Diagnostica, Inc. · DAP · Feb 13, 2008 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K080069

## Device Facts

- **Applicant:** American Diagnostica, Inc.
- **Product Code:** [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP.md)
- **Decision Date:** Feb 13, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7320
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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.

## Predicate Devices

- DIMERTEST® ([K974596](/device/K974596.md))

## 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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K080069](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K080069)

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