(34 days)
No
The device description and performance studies focus on a traditional latex agglutination assay and do not mention any AI or ML components.
No.
The device is described as an in vitro diagnostic (IVD) device intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device evaluates circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma, which is used to detect the presence of an antigen (D-dimer) in plasma, indicating reactive fibrinolysis. This evaluation provides information on the state of an individual's health by identifying a biological marker related to a medical condition.
No
The device description clearly states it is a "qualitative and semi-quantitative latex agglutination slide test" and describes a "latex reagent" consisting of antibodies attached to polystyrene latex particles. This indicates a physical, chemical-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "latex agglutination slide test for cross-linked fibrin degradation products in human plasma." This is a classic description of an in vitro diagnostic test.
- Sample Type: The test uses "human plasma," which is a biological sample taken from a patient.
- Mechanism: The test relies on an immunological reaction (antibody-antigen binding leading to agglutination) that occurs in vitro on a slide.
- Performance Studies: The document describes performance studies conducted on "Blood Bank donor plasma samples" and "plasmas from hospital patients," further confirming its use with human biological samples for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K882944; DIMERTEST®) indicates that this device is being compared to a previously cleared device, which is a common process for IVDs seeking regulatory clearance.
- Reference Device: The mention of a "Reference Device(s)" with a K number (K945642; Dimertest Gold ElA method) also points to a comparison with another cleared diagnostic method.
All these factors strongly indicate that the DIMERTEST® Latex Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
The DIMERTEST® Latex Kit is a qualitative and semi-quantitative latex agglutination slide test for cross-linked fibrin degradation products in human plasma. The active ingredient in the DIMERTEST® product is the latex reagent. This reagent consists of highly specific D-dimer monoclonal antibodies attached to polystyrene latex particles. When mixed with the latex reagent, the presence of antigen (Ddimer) in a plasma sample results in agglutination of the latex particles which can be seen with the unaided eye. A semi-quantitative estimate of the Ddimer concentration can be made by preparing dilutions of a plasma sample. The concentration is determined according to a titration matrix.
Plasma from normal individuals is not expected to agglutinate DIMERTEST® Latex. Reactive fibrinolysis will be demonstrated by latex agglutination at a plasma concentration of approximately 200 ng/mL D-dimer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Analytical performance:
a. Precision/Reproducibility:
Intra-assay (within run) reproducibility was determined by testing 10 replicates from three plasma pools that contained D-dimer titers ranging from 0 to 4. The test results for all ten replicates from each pool had the same values.
Inter-assay (run-to-run) reproducibility was determined by testing 10 plasma pools that had Ddimer titers ranging from 1 to 16. The assay values of the replicates from 10 runs of each plasma pool tested over a 28-day period did not vary by more than 1 titer.
b. Linearity/assay reportable range:
The reportable range for the semi-quantitative assay is 200 to 3,200 ng/mL Ddimer.
c. Traceability, Stability, and Expected Values:
The DIMERTEST® kit contains a positive control and a negative control.
The vial labels contain the expiration dates. Reagents are stored between 20 C and 8 €.
Normal plasma samples give negative results.
d. Analytical specificity:
The DIMERTEST® reagent showed no assay interference when plasma samples were spiked with interferents at the following concentrations:
Bilirubin 0.2 mg/dL
Lipids (triglycerides) 30 mg/dL
Hemoglobin 5.0 mg/dL
Protein (gamma globulin) 0.06 g/mL
The DIMERTEST® reagents are insensitive to rheumatoid factor.
e. Assay cut-off:
200 ng/mL D-dimer
- Comparison studies:
a. Method Comparison of the Modified DIMERTEST® Reagent versus the Predicate DIMERTEST® Reagent:
Specificity Comparison: An in-house comparative study of 170 Blood Bank donor plasma samples from ostensibly healthy volunteers was performed. 95.3% of the normal results were negative by the modified DIMERTEST® reagent compared to 97.6% negative by the predicate DIMERTEST® reagent.
Sensitivity Comparison: 145 plasmas from hospital patients who had a high probability of thrombotic conditions were analyzed in an in-house comparative study.
Clinical Cut-off Change: The new value of the diagnostic cut-off for the modified DIMERTEST® reagent was calculated to be 200 ng/ml. D-dimer with the linear curve generated from the N=145 sensitivity study plasma samples. The D-dimer values that were determined with the predicate DIMERTEST® reagent were plotted as the x-axis and the D-dimer values that were determined with the modified DIMERTEST® reagent were plotted as the y-axis. With a slope of 1.19, the new cutoff was calculated to be approximately 20% less than the predicate DIMERTEST® reagent cut-off of 250 ng/mL D-dimer.
The new cut-off value was validated with an additional 373 patient plasmas that were tested by the modified DIMERTEST® reagent and also tested concurrently by the FDA cleared Dimertest Gold ElA method (K945642).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity: 95.3% negative by the modified DIMERTEST® reagent compared to 97.6% negative by the predicate DIMERTEST® reagent.
The new cut-off for the modified DIMERTEST® reagent was calculated to be 200 ng/mL D-dimer.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
0
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21 CFR part 807.92.
A. 510(k) Number: K974596
B. Purpose for the Submission:
To seek clearance for the existing DIMERTEST® product that was manufactured by AGEN Biomedical Ltd., but is now manufactured by American Diagnostica Inc. (ADI) due to the transfer of ownership of the DIMERTEST® product-line to ADI. The performance characteristics of the modified DIMERTEST® product and a summary of the modifications made to the DIMERTEST® product that had been cleared in 1988 (K882944) are described in the DIMERTEST® 510(k) submission K974596.
C. Measurand: D-Dimer
D. Type of Test: Latex Immuno Assay
E. Applicant:
Submitted by: American Diagnostica Inc. 500 West Avenue Stamford, CT 06902 Tel. 203 602-7777 Ext. 14 Fax 203 602-5553
Contact: Leigh Avres Director of Regulatory Affairs and Quality Assurance 203-602-7777 x 14
Summary Prepared: December 17, 2007
F. Proprietary and Established Name: DIMERTEST®
500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 USA · Tel. +1.203.602.7777 · Fax +1.203.602.5553 2007DEC17 DIMERTEST® 510(K) Summary.doc Page 1 of 5
1
G. Regulatory Information:
-
- Regulation section: 864.7320
-
- Classification: Class II
-
- Product code: DAP
-
- Panel: Hematology
H. Intended Use:
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
I. Device Description:
The DIMERTEST® Latex Kit is a qualitative and semi-quantitative latex agglutination slide test for cross-linked fibrin degradation products in human plasma. The active ingredient in the DIMERTEST® product is the latex reagent. This reagent consists of highly specific D-dimer monoclonal antibodies attached to polystyrene latex particles. When mixed with the latex reagent, the presence of antigen (Ddimer) in a plasma sample results in agglutination of the latex particles which can be seen with the unaided eye. A semi-quantitative estimate of the Ddimer concentration can be made by preparing dilutions of a plasma sample. The concentration is determined according to a titration matrix.
Plasma from normal individuals is not expected to agglutinate DIMERTEST® Latex. Reactive fibrinolysis will be demonstrated by latex agglutination at a plasma concentration of approximately 200 ng/mL D-dimer.
J. Substantial Equivalence Information:
-
- Predicate device name(s): DIMERTEST®
-
- Predicate 510(k) number: K882944
3. Comparison of the Modified DIMERTEST® Kit to the Predicate DIMERTEST® Kit:
| SEQ | Kit Component | Is there a
difference from
the Predicate
DIMERTEST® kit? | Description of the Change that Was Made
to the Modified DIMERTEST® Kit |
|-----|---------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Latex Reagent | Yes | The supplier for the latex starting material
was changed, the latex reagent in the kit
is now supplied with a dropper bottle, and
the cut-off value was changed from 250
ng/mL to 200 ng/mL. |
500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 USA · Tel. +1.203.602.7777 · Fax +1.203.602.5553 2007DEC17 DIMERTEST® 510(K) Summary.doc Page 2 of 5
2
| SEQ | Kit Component | Is there a
difference from
the Predicate
DIMERTEST® kit? | Description of the Change that Was Made
to the Modified DIMERTEST® Kit |
|-----|------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Positive Control | Yes | The formulation was not changed, but the
bottle in the kit is now provided with a
dropper tip. |
| 3 | Negative
Control | Yes | This was not provided in the predicate
DIMERTEST® kit. It is a liquid formulation
ready to use and it has a dropper tip. |
| 4 | Buffer Solution | No | No changes |
| 5 | Dropper Pipette | Yes | Deleted from the modified
DIMERTEST® kit. No longer necessary
because the latex reagent is now supplied
with a dropper tip. |
| 6 | Reading Cards | Yes | Changed to a pack of 10 disposable black
background cards with 8 reaction wells
marked on each card. |
| 7 | Plastic Stirrers | Yes | There was a minor change to the shape of
the stirrers. |
| 8 | Intended Use | No | No changes |
| 9 | Operating
Principle | No | No changes |
| 10 | Capture
Antibody | No | No changes |
| 11 | Assay Sample | No | No changes |
K. Standard/Guidance Document Referenced (if applicable): N/A
L. Test Principle:
The assay is based on a visible agglutination that occurs when a patient plasma containing D-Dimer is mixed with latex particles coated with monoclonal antibodies.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
a. Precision/Reproducibility:
Intra-assay (within run) reproducibility was determined by testing 10 replicates from three plasma pools that contained D-dimer titers ranging from 0 to 4. The test results for all ten replicates from each pool had the same values.
Inter-assay (run-to-run) reproducibility was determined by testing 10 plasma pools that had Ddimer titers ranging from 1 to 16. The assay values of the replicates from 10 runs of each plasma pool tested over a 28-day period did not vary by more than 1 titer.
500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 USA · Tel. +1.203.602.7777 · Fax +1.203.602.5553 2007DEC17 DIMERTEST® 510(K) Summary.doc Page 3 of 5
3
b. Linearity/assay reportable range:
The reportable range for the semi-quantitative assay is 200 to 3,200 ng/mL Ddimer.
c. Traceability, Stability, and Expected Values:
The DIMERTEST® kit contains a positive control and a negative control.
The vial labels contain the expiration dates. Reagents are stored between 20 C and 8 €.
Normal plasma samples give negative results.
d. Analytical specificity:
The DIMERTEST® reagent showed no assay interference when plasma samples were spiked with interferents at the following concentrations:
Bilirubin 0.2 mg/dL Lipids (triglycerides) 30 mg/dL Hemoglobin 5.0 mg/dL Protein (gamma globulin) 0.06 g/mL
The DIMERTEST® reagents are insensitive to rheumatoid factor.
e. Assay cut-off:
200 ng/mL D-dimer
- Comparison studies:
a. Method Comparison of the Modified DIMERTEST® Reagent versus the Predicate DIMERTEST® Reagent:
Specificity Comparison
An in-house comparative study of 170 Blood Bank donor plasma samples from ostensibly healthy volunteers was performed. 95.3% of the normal results were negative by the modified DIMERTEST® reagent compared to 97.6% negative by the predicate DIMERTEST® reagent.
Sensitivity Comparison
145 plasmas from hospital patients who had a high probability of thrombotic conditions were analyzed in an in-house comparative study.
500 West Avenue, P.O. Box 110215. Stamford, CT 06911-0215 USA · Tel. +1.203.602.7777 · Fax +1.203.602.5553 2007DEC17 DIMERTEST® 510(K) Summary.doc Page 4 of 5
4
Clinical Cut-off Change
The new value of the diagnostic cut-off for the modified DIMERTEST® reagent was calculated to be 200 ng/ml. D-dimer with the linear curve generated from the N=145 sensitivity study plasma samples. The D-dimer values that were determined with the predicate DIMERTEST® reagent were plotted as the x-axis and the D-dimer values that were determined with the modified DIMERTEST® reagent were plotted as the y-axis. With a slope of 1.19, the new cutoff was calculated to be approximately 20% less than the predicate DIMERTEST® reagent cut-off of 250 ng/mL D-dimer.
The new cut-off value was validated with an additional 373 patient plasmas that were tested by the modified DIMERTEST® reagent and also tested concurrently by the FDA cleared Dimertest Gold ElA method (K945642).
N. Conclusion
The modified DIMERTEST® product is substantially equivalent to the predicate DIMERTEST® product based on the comparison summary and the performance characteristics.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
FEB 1 8 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
American Diagnostica, Inc. C/O Leigh Ayres 500 West Avenue Stamford, Connecticut 06902
Re: K080069 Trade/Device Name: Dimertest Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: Class II Product Code: DAP Dated: December 19, 2007 Received: January 11, 2008
Dear Ms. Ayres:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
6
Page 2 -- American Diagnostica
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plcase contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Katt Beckerl
Robert L. Becker, Jr., MA., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device name:
DIMERTEST®
Indications for Use:
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/9 description: The image shows a square with a check mark inside. The square is outlined in black, and the check mark is also black. The check mark starts at the bottom left corner of the square, goes up to the top right corner, and then goes down to the bottom right corner.
.
Prescription Use (Per Title 21 CFR part 801.109)
OR
Over-The-Counter-Use
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Sai
510(k) KD80069