DIMERTEST
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 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K080069 · Feb 13, 2008 | DIMERTEST | American Diagnostica, Inc. | Hospital patient plasma samples; Blood bank donor plasma samples | Retrospective clinical plasma samples were used to compare the performance of the modified DIMERTEST® reagent against the predicate device and to validate the new clinical cut-off value. | Method comparison; Clinical plasma samples; Sensitivity/Specificity validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| In-house comparative study (Specificity); Retrospective comparative study | Ostensibly healthy blood bank donors; Sample Size: 170; Number of Sites: 1 | Predicate DIMERTEST® reagent | Specificity (negative result rate) |
| In-house comparative study (Sensitivity); Retrospective comparative study | Hospital patients with high probability of thrombotic conditions; Sample Size: 145; Number of Sites: 1 | Predicate DIMERTEST® reagent | Sensitivity and clinical cut-off calculation |
| Cut-off validation study; Retrospective validation study | Patient plasma samples; Sample Size: 373; Number of Sites: 1 | FDA cleared Dimertest Gold EIA method (K945642) | Validation of new cut-off value |
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.
