(549 days)
Not Found
No
The device description details a standard immunoturbidimetric assay with optical measurement and calculation based on a calibration curve. There is no mention of AI/ML terms, image processing, or data training/testing sets, which are typical indicators of AI/ML integration.
No
Explanation: This device is an in vitro diagnostic (IVD) device used to measure D-Dimer levels in human plasma, which aids in detecting intravascular coagulation and fibrinolysis. It is not used for direct treatment or therapy.
Yes
The D-Dimer Assay aids in detecting intravascular coagulation and fibrinolysis, which are diagnostic purposes. The document states "For in vitro diagnostic use only" multiple times.
No
The device description clearly states it is a latex enhanced immunoturbidimetric assay that measures turbidity optically, indicating a physical, hardware-based measurement system.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use only." in the Intended Use / Indications for Use section for the D-Dimer Assay, the Calibrator Set, and the Control Set.
- The device is intended for the quantitative determination of D-Dimer in human plasma, which is a biological sample.
- The measurement is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis, which are medical conditions.
- The intended users are in clinical laboratories.
These points clearly indicate that the device is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
GHH, DAP, JIT
Device Description
Thrombus formation is normally followed by an immediate fibrinolytic response. The resultant generation of plasmin causes the release of fibrin degradation products (predominantly containing D-Dimer) into the circulation.
Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.
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)
The precision of the Diazyme D-Dimer Assay was evaluated internally and externally.
Internal Study (Precision):
Three levels of pooled citrated plasma specimens (0.60 µg/mL, 2.41 µg/mL, and 5.88 µg/mL FEU) and three levels of D-Dimer controls (0.97, 2.99, and 7.47 µg/mL FEU) were tested with 2 runs per day with duplicates over 20 working days.
Key results:
Plasma Samples Within Run Precision CV%: 1.4% - 5.0%.
Plasma Samples Total Precision CV%: 2.7% - 6.2%.
Control Samples Within Run Precision CV%: 1.4% - 2.9%.
Control Samples Total Precision CV%: 2.8% - 4.4%.
External Study (Precision):
Four different patient samples of citrated plasma (0.36 µg/mL, 1.06 µg/mL, 3.53 µg/mL, and 7.20 µg/mL FEU) were tested in duplicates with 2 runs per day over 5 nonconsecutive working days at three external sites.
Key results: Total CV% ranged from 3.5% to 11.5%.
LOB, LOD, and LOQ:
LOB was determined to be 0.06 µg/mL FEU.
LOD was determined to be 0.09 µg/mL FEU.
LOQ (lowest concentration for which CV is less than a target of 20%) is 0.15 µg/mL FEU.
Linearity:
Diazyme D-Dimer assay is linear from 0.15 to 8.0 µg/mL FEU.
Method Comparison:
Study Type: Accuracy comparison to a legally marketed D-Dimer device.
Sample size: 128 citrated plasma samples (88 unique samples) with D-Dimer ranging from 0.17 to 7.95 µg/mL FEU.
Key results:
Slope: 0.979 (95% CI: 0.909 to 1.060)
Intercept: -0.106 (95% CI: -0.260 to 0.026)
R2: 0.939
The bias around the medical decision point is -0.12 µg/ml FEU.
Interference:
Studies showed no interference (less than 10% bias) from Hemoglobin (up to 500 mg/dL), Bilirubin (up to 40 mg/dL), Bilirubin Conjugated (up to 40 mg/dL), Triglycerides (up to 1000 mg/dL), Ascorbic acid (up to 176 mg/dL), Rheumatoid Factor (up to 100 IU/mL), Heparin (up to 1.5 IU/mL), and HAMA (up to 490 ng/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
K1121205
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Submitter's name:
Diazyme Laboratories
JAN 2 4 2013
Submitter's address:
12889 Gregg Court Poway, CA 92064 USA
Name of Contact Person:
Dr. Abhijit Datta Diazyme Laboratories 12889 Gregg Court . Poway, CA 92064 Phone: 858-455-4762 Fax: 858-455-2120
January 24, 2013
Date the Summary was Prepared:
Name of the Device
D-Dimer Assay Kit D-Dimer Assay Calibrator Set D-Dimer Assay Control Set
Diazyme D-Dimer Assay Kit
Diazyme D-Dimer Assay Calibrator Set Diazyme D-Dimer Assay Control Set
Trade Name:
Common/Usual Name
Device Classification Name
Product code:
GHH Fibrin Split Products DAP Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control JIT Calibrator, Secondary
. Panel:
Submission Type
Regulation Number
Hematology (81)
D-Dimer Assay
D-Dimer Test System
510k
21CFR 866.7320
1
1
Device Class Class II Predicate Device: Roche TINA-QUANT D-DIMER SYSTEM (K062203) Manufacturing Address Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA
Establishment Registration 2032900
Description of the Device:
Summarv
Thrombus formation is normally followed by an immediate fibrinolytic response. The resultant generation of plasmin causes the release of fibrin degradation products (predominantly containing D-Dimer) into the circulation.
Assay Principle
Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.
Indications for Use:
The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
2
| Roche Tina-Quant D-Dimer K062203 | Diazyme D-Dimer Assay |
|---|---|
| Reagent 1 | |
| buffer solution, ready to use | Reagent 1 |
| 100 mM Tris-buffer solution with 0.09% so- | |
| dium azide, ready to use | |
| Reagent 2 | |
| Anti-D-Dimer latex suspension (0.15%) in | |
| pH 7.2 buffer matrix | Reagent 2 |
| Suspension of latex particles (in vitro quantitative determina- | |
| tion of D-Dimer in citrated or li-heparin | |
| plasma. | For the in vitro quantitative determina- |
| tion of D-Dimer in citrated plasma. | Same |
·
Type of Test
| Roche Tina-Quant D-Dimer K062203 | Diazyme D-Dimer Assay | Equivalency |
|---|---|---|
| Quantitative | Quantitative | Same |
Specimen Type
| Roche Tina-Quant D-Dimer K062203 | Diazyme D-Dimer Assay | Equivalency |
|---|---|---|
| ---------------------------------- | ----------------------- | ------------- |
. . :
4
| Human citrated or li-heparin plasma. | Human citrated plasma. | Same |
|---|---|---|
| Product Type | ||
| Roche Tina-Quant D-Dimer K062203 | Diazyme D-Dimer Assay | Equivalency |
| Assay reagent kit, calibrator kit, quality | ||
| control kit. | Assay reagent kit, calibrator kit, quality | |
| control kit. | Same |
Performance
| Roche Tina-Quant D-Dimer K062203 | Diazyme D-Dimer Assay |
|---|---|
| Working Range: 0.15-9 µg/mL FEU D- | |
| Dimer | Linear Range: 0.15-8 µg/mL FEU D-Dimer |
| Precision: CV% of 0.8 - 8.3% | Precision: CV% of 1.4% - 6.2% |
| Methods Comparion (vs Asserachrom | |
| D-Dimer K862156): | Methods Comparion (vs. Roche Tina-Quant D- |
| Dimer K062203): | |
| Correlation Coefficient: 0.775 | |
| Slope/Intercept: y = 1.03/-0.11 | Correlation Coefficient: 0.939 |
| Slope/ y Intercept: y = 0.979 /-0.10 |
Calibrator Comparison
| Roche D-Dimer Calibrator | Diazyme D-Dimer Calibrator | Equivalency |
|---|---|---|
| Separately packaged lot specific | ||
| calibrator kit. Lyophilized. | Separately packaged lot specific | |
| calibrator kit. Lyophilized. | Same |
Control Comparison
| Roche D-Dimer Control I/II | Diazyme D-Dimer Control | Equivalency |
|---|---|---|
| Separately packaged quality control kit | ||
| designed for specific assay. | ||
| Lyophilized. | Separately packaged quality control set | |
| designed for specific assay. | ||
| Lyophilized. | Same |
Performance Testing Summaries:
The data (precision, method comparison, linearity, LOB/LOD/LOQ and interference) determined using Roche Modular P is given below.
Precision
Internal Study
5
The precision of the Diazyme D-Dimer Assay was evaluated according to Clinical Laboratory Standards Institute EP5-A guideline.
In the study, three levels of pooled citrated plasma specimens containing 0.60 µg/mL, 2.41 ug/mL and 5.88 µg/mL FEU, respectively. The low plasma sample was unaltered. The other two plasma samples were spiked with D-Dimer stock solution to targeted concentrations and assayed. Three levels of D-Dimer controls containing 0.97, 2.99 and 7.47 µg/mL FEU, respectively were also tested with 2 runs per day with duplicates over 20 working days with three lops of reagent and three lots of calibrators. The combined results are shown below:
| | Level 1: 0.60 µg/mL
FEU | Level 2: 2.41 µg/mL
FEU | Level 3: 5.88 µg/mL
FEU |
|-----------------|----------------------------|----------------------------|----------------------------|
| Data Points N | 240 | 240 | 240 |
| Mean (g/mL FEU) | 0.60 | 2.41 | 5.88 |
| SD (g/mL FEU) | 0.03 | 0.05 | 0.08 |
| CV% | 5.0% | 2.0% | 1.4% |
Plasma Samples Within Run Precision
Plasma Samples Total Precision
| | Level 1: 0.60 µg/mL
FEU | Level 2: 2.41 µg/mL
FEU | Level 3: 5.88 µg/mL
FEU |
|-----------------|----------------------------|----------------------------|----------------------------|
| Data Points N | 240 | 240 | 80 |
| Mean (g/mL FEU) | 0.60 | 2.41 | 5.88 |
| SD (g/mL FEU) | 0.04 | 0.07 | 0.19 |
| CV% | 6.2% | 2.7% | 3.2% |
Control Samples Within Run Precision
| Level 1: 0.97 µg/mL | Level 2: 2.99 µg/mL | Level 2: 7.47 µg/mL | |
|---|---|---|---|
| FEU | FEU | FEU | |
| Data Points N | 240 | 240 | 240 |
| Mean (g/mL FEU) | 0.97 | 2.99 | 7.47 |
| SD (g/mL FEU) | 0.03 | 0.05 | 0.11 |
| CV% | 2.9% | 1.6% | 1.4% |
Control Samples Total Precision
| | Level 1: 0.97 µg/mL
FEU | Level 2: 2.99 µg/mL
FEU | Level 2: 7.47 µg/mL
FEU |
|-----------------|----------------------------|----------------------------|----------------------------|
| Data Points N | 240 | 240 | 240 |
| Mean (g/mL FEU) | 0.97 | 2.99 | 7.47 |
| SD (g/mL FEU) | 0.04 | 0.08 | 0.27 |
| CV% | 4.4% | 2.8% | 3.6% |
6
External Study
The precision of the Diazyme D-Dimer Assay was also evaluated at three external sites by intended users. In the study, four different patient samples of citrated plasma containing 0.36 ug/mL, 1.06 µg/mL, 3.53 µg/mL and 7.20 µg/mL FEU respectively, were tested in duplicates with 2 runs per day over 5 nonconsecutive working days using three lots of reagent, three lots of calibrators, three different clinical testing sites, three different operators and three different instruments. The results are shown below:
| Sample | within
run | between run | between day | between lot | total | Mean
µg/mL
FEU |
|--------|---------------|-------------|-------------|-------------|-------|----------------------|
| 1 | 8.9% | 8.3% | 7.6% | 7.1% | 11.5% | 0.36 |
| 2 | 3.8% | 3.6% | 7.4% | 8.3% | 8.3% | 1.06 |
| 3 | 2.9% | 3.9% | 3.1% | 0.7% | 4.7% | 3.53 |
| 4 | 1.6% | 3.1% | 2.4% | 1.5% | 3.5% | 7.20 |
LOB, LOD, and LOO
The LOB, LOD, LOQ of the Diazyme D-Dimer Assay was determined according to CLSI EP17-A. LOB was determined to be 0.06 µg/mL FEU; LOD was determined to be 0.09 µg/mL FEU. To determine LOQ, specimens with mean measured concentrations ranging from 0.02 to 0.93 were assayed. Based on the EP evaluator-8 fitted model, the LOQ (lowest concentration for which CV is less than a target of 20%) is 0.15 µg/mL FEU.
Linearity
Eleven levels of the D-Dimer linearity set were prepared by diluting a specimen containing 8.0 ug/mL FEU with saline according to Clinical and Laboratory Standards Institute EP6-A and tested on Modular P. Diazyme D-Dimer assay is linear from 0.15 to 8.0 µg/mL FEU.
Method Comparison
To demonstrate accuracy, the Diazyme D-Dimer Assay was evaluated by testing individual citrated plasma from the intended target population (Intensive Care Unit, Obstetrics, Trauma, Post-Operative and Operating Room) with comparison to a legally marketed D-Dimer revince it the manufacturer site and two external clinical laboratories. A total of 128 citrated plasma samples (88 unique samples) with D-Dimer ranging from 0.17 to 7.95 µg/mL FEU were compared. Repeat testing was addressed by bootstrapped regression analysis with stratification is shown below:
| Parameter | Total of 3 sites |
|---|---|
| Slope | 0.979 |
| 95% CI | 0.909 to 1.060 |
| Intercept | -0.106 |
| 95% CI | -0.260 to 0.026 |
| R2 | 0.939 |
The bias around the medical decision point is -0.12 µg/ml FEU
7
Interference
The following substances do not interfere with this assay at the levels tested (less than 10% bias):
Hemoglobin: Bilirubin: Bilirubin Conjugated: Triglycerides: Ascorbic acid: Rheumatoid Factor Heparin HAMA
up to 500 mg/dL up to 40 mg/dL up to 40 mg/dL up to 1000 mg/dL up to 176 mg/dL up to 100 IU/mL up to 1.5 IU/mL up to 490 ng/mL
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized graphic of an abstract symbol, consisting of three curved lines that resemble a person embracing another person.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Diazyme Laboratories c/o Dr. Abhijit Datta 12889 Gregg Court Poway, CA 92064
Jan 24, 2013
Re: K112120
Trade/Device Name: Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Control Set and Diazyme D-Dimer Assay Calibrator Set Regulation Number: 21 CFR §864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: GHH, DAP, JIT Dated: January 17, 2013
Received: January 18, 2013
Dear Dr. Datta:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
9
Page 2 - Dr. Abhijit Datta
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Maria M. Chan -S
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological
Health Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (If Known): K112120
Device Name: Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, Diazyme D-Dimer Assay Control Set.
Indications for Use:
The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diayzme D-Dimer Assay Calibrator Set is intended for use in the calibration of the D-Dimer assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Assay Control Set is intended for use as quality controls for the Diazyme D-Dimer assay only. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Lenk L. L.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K112120 510(k)
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