(422 days)
Roche Modular P (K953239/005)
No
The description details a standard in vitro diagnostic assay run on a clinical chemistry analyzer. The data processing involves spline-fitting and interpolation, which are traditional statistical methods, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
Explanation: This device is an in vitro diagnostic (IVD) assay designed to quantify fibrinogen levels in human plasma for diagnostic purposes, not to treat a condition.
Yes
The device is an "in vitro diagnostic" device, as stated multiple times in the "Intended Use / Indications for Use" section. It quantitatively determines fibrinogen levels in human plasma, which is used for diagnostic purposes.
No
The device description clearly outlines physical reagents (R1 and R2), calibrators, and controls, which are all tangible components. While it utilizes software on the Roche Modular P analyzer for control and calculation, the core of the device is the chemical assay and its associated physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is a clear indicator that the device is intended for use outside of the body to diagnose or aid in the diagnosis of a condition.
- Device Description: The description details a system that analyzes human plasma samples to determine fibrinogen levels. This process involves reagents, calibrators, and controls, which are all components typically associated with in vitro diagnostic tests.
- Sample Type: The assay is performed on "citrated human plasma," which is a biological sample collected from a patient.
- Analysis Method: The device uses a Roche Modular P analyzer to measure changes in absorbance, a common method for quantitative in vitro diagnostic assays.
- Calibration and Controls: The system includes calibrators and controls, which are essential for ensuring the accuracy and reliability of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies (Precision, Linearity, Method Comparison, Interference) that are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Kamiya K-Assay Fibrinogen) further confirms that this device is being compared to another IVD device.
All of these factors collectively indicate that the Diazyme Fibrinogen Assay System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.
The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
Product codes
GIS, GFX, GIL
Device Description
The Diazyme Fibrinogen Assay is based on an immunoturbidimetric assay. Fibrinogen in plasma binds to specific anti-fibrinogen antibody and forms immune complexes. The degree of turbidity caused by immune complexes can be measured optically at 340nm, and is proportional to the quantity of fibrinogen in the sample. The instrument calculates the fibrinogen concentration by interpolation of obtained signal of a 4-point calibration curve prepared from calibrators of known concentrations.
Diazyme Fibrinogen Assay System consists of the following items:
-
- The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide.
-
- Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide
-
- Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide.
The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals.
The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths.
After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-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
The performance of this device has not been established in neonate and pediatric patient populations.
Intended User / Care Setting
trained professionals
For in vitro diagnostic use only.
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
Precision: The precision of the Diazyme Fibrinogen Assay was evaluated according to CLSI EP5-A2 guideline. In the study, 6 citrated plasma samples including one sample close to the very low end of the AMR and one sample close to the very high end of the AMR were tested with three lots of reagents.
Sample Repeatability (Three Reagent Lots Combined): N=240 for each of 6 plasma samples. Mean mg/dL ranged from 107.3 to 823.9. Total (SD, %CV) ranged from 5.2, 5% to 42.9, 5%.
Calibrator Repeatability (Three Reagent Lots and Three Calibrator Lots Combined): N=360 for each of 3 calibrator levels. Mean ranged from 262 to 1130. Total (SD, %CV) ranged from 18.8, 7% to 64.0, 6%.
Control Repeatability (Two Reagent Lots and One Control Lot Combined): N=160 for each of 2 control levels. Mean ranged from 173.2 to 607.5. Total (SD, %CV) ranged from 4.1, 2% to 15.2, 3%.
Multi-site precision (reproducibility) study was performed at two external sites and Diazyme site on Modular P analyzer. The same sets of 6 citrated plasma samples were used. Total (SD, %CV) for plasma samples (N=60 per sample) ranged from 7.4, 7% to 62.2, 9%. Total (SD, %CV) for calibrators (N=120 per calibrator) ranged from 19.3, 8% to 73.5, 7%. Total (SD, %CV) for controls (N=120 per control) ranged from 10.0, 6% to 34.6, 6%.
Linearity: The eleven levels linearity set was prepared by mixing a pooled fibrinogen spiked plasma sample containing 1000 mg/dL fibrinogen and saline at different proportions according to Clinical and Laboratory Standards Institute EP6-A.
Results: Diazyme Fibrinogen Assay is linear up to 1032.8 mg/dL. The analytical measuring range (AMR) of Diazyme Fibrinogen assay is claimed to be 100-900 mg/dL.
Method Comparison: Human plasma samples were tested with the Diazyme Fibrinogen Assay and the obtained results were compared to the predicate method according to CLSI EP9-A2 guideline. A total of 176 samples tested across 3 clinical sites. All samples were tested in singlet with both methods.
Results: Regular Regression: n=176, Slope=0.986 (95% CI: 0.975 – 0.997), Intercept=2.72 (95% CI: -1.70 - 7.13), Standard Error of Estimate=15.31, Correlation Coefficient(R)=0.9973. Sample Range (Diazyme)=107.5 - 870.0. Deming regression: n=176, Slope=0.989 (95% CI: 0.978 – 0.999), Intercept=1.80 (95% CI: -2.68 - 6.22), Standard Error of Estimate=15.32, Correlation Coefficient(R)=0.9973. Sample Range (Diazyme)=107.5 - 870.0.
Interference: Tested according to CLIA EP7-A "Interference Testing in Clinical Chemistry".
Results: Endogenous substances (Ascorbic Acid, Bilirubin, Bilirubin Conjugated, Hemoglobin, Rheumatoid Factor, Triglycerides) produced less than 10% deviation at specified concentrations. Common therapeutic substances (Acetylsalicyclic Acid, Na2-Cefoxitin, Ibuprofen, fibrin degradation product and coagulation inhibitors such as warfarin, dabigatran, hirudin, rivaroxaban, and argatroban, heparin) showed no significant interference (
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2016
Diazyme Laboratories Abhijit Datta, Ph.D. Director, Technical Operations 12889 Gregg Court Poway, CA 92064
Re: K143470
Trade/Device Name: Diazyme Fibrinogen Assay Diazyme Fibrinogen Calibrator Set Diazyme Fibrinogen Control Set Regulation Number: 21 CFR 864.7340 Regulation Name: Fibrinogen determination system Regulatory Class: Class II Product Code: GIS, GFX, GIL Dated: January 15, 2016 Received: January 19, 2016
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
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143470
Device Name
Diazyme Fibrinogen Assay; Diazyme Fibrinogen Calibrator Set; Diazyme Fibrinogen Control Set
Indications for Use (Describe)
The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.
The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The performance of this device has not been established in neonate and pediatric patient populations.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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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 SMDA 1990 and 21 CFR 807.92.
| Submitter's name: | Diazyme Laboratories |
|---|---|
| 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 | |
| Date the Summary was Prepared: | January 15, 2016 |
| Name of the Device | Diazyme Fibrinogen Assay |
| Diazyme Fibrinogen Calibrator Set | |
| Diazyme Fibrinogen Control Set | |
| Trade Name: | Diazyme Fibrinogen Assay |
| Diazyme Fibrinogen Calibrator Set | |
| Diazyme Fibrinogen Control Set | |
| Common/Usual Name | Diazyme Fibrinogen Assay |
| Device Classification Name | Fibrinogen, Antigen, Antiserum, Control, Calibrator |
| Product code: | GIS, Fibrinogen Determination System |
| GFX, Fibrinogen Standard | |
| GIL, Plasma, Fibrinogen Control | |
| Panel: | Hematology |
| Submission Type | Traditional 510k |
| Regulation Number | 21CFR 864.7340 Fibrinogen determination system |
| Device Class | Class II |
| Predicate Device: | Kamiya K-Assay Fibrinogen (K993482) |
| Manufacturing Address | Diazyme Laboratories |
5
12889 Gregg Court Poway, CA 92064 USA
Establishment Registration 2032900
DESCRIPTION OF THE DEVICE
Clinical Significance
Fibrinogen is a ~340 kDa plasma glycoprotein essential to blood clot formation. In the final step of the coagulation cascade, thrombin cleaves fibrinogen to form insoluble fibrin monomers, which then polymerize to form fibrin clots.
Abnormal plasma fibrinogen quality or quantity can occur as inherited or acquired disorders. Higher levels of fibrinogen are associated with inflammation, trauma, surgery, and pregnancy. A decrease of the fibrinogen level is observed in disseminated intravascular coagulation (DIC), fibrinolysis and hereditary diseases. Additionally, fibrinogen is an acute phase reactant, thus upregulated during inflammation or tissue damage.
Assay Principle
The Diazyme Fibrinogen Assay is based on an immunoturbidimetric assay. Fibrinogen in plasma binds to specific anti-fibrinogen antibody and forms immune complexes. The degree of turbidity caused by immune complexes can be measured optically at 340nm, and is proportional to the quantity of fibrinogen in the sample. The instrument calculates the fibrinogen concentration by interpolation of obtained signal of a 4-point calibration curve prepared from calibrators of known concentrations.
Detailed Device Description
Diazyme Fibrinogen Assay System consists of the following items:
-
- The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide.
-
- Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide
-
- Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide.
The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous
6
blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals.
The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths.
See Reaction Scheme.
Image /page/6/Figure/3 description: The image shows a timeline of a chemical reaction. At time 0, 200 microliters of R1 and 6 microliters of sample are added. After some time at 37 degrees Celsius, 50 microliters of R2 are added at 5 minutes. At 6 minutes, A1 is measured at 340 nm, and at 10 minutes, A2 is measured.
After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-point calibration curve.
#: The Modular P analyzer performs automatic on-board 1: 20 dilution using saline (5 uL + 100 uL saline).
Use the provided Diazyme Fibrinogen Assay (DZ768A) Application Parameters for Roche Modular P and enter the application parameters via the keyboard, settings sheet or barcode sheet, as appropriate.
| Modular P Applications | |
|---|---|
| Measuring mode | Absorbance |
| Abs. calculation mode | 2 Point END |
| Reaction mode | S-R1/R3 |
| Reaction direction | Increase |
| Primary/Secondary Wavelength | 340 nm/700nm |
| Calc. first/last | 18/34 |
| Unit | mg/dL |
| Pipetting parameters | |
| R1 | 200 µL |
| Sample | 5 µL |
| Sample diluent (saline) | 100 µL (1:20 dilution |
| Diluted Sample | 6 µL |
| R2 | 50 µL |
| Total volume | 256 µL |
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Indications for Use:
The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.
The Diazyme Fibrinogen Calibrator Set is intended for use in the calibration of the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The Diazyme Fibrinogen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
Performance Characteristics of Subject Device
Precision
The precision of the Diazyme Fibrinogen Assay was evaluated according to CLSI EP5-A2 guideline. In the study, 6 citrated plasma samples including one sample close to the very low end of the AMR and one sample close to the very high end of the AMR were tested with three lots of reagents. The results are summarized in the following table:
| Sample | N | Mean
mg/dL | Within-Run
(SD, %CV) | Between-Run
(SD, %CV) | Between-Lot
(SD, %CV) | Between-Day
(SD, %CV) | Total
(SD, %CV) |
|----------|-----|---------------|-------------------------|--------------------------|--------------------------|--------------------------|--------------------|
| Plasma 1 | 240 | 453.4 | 8.0, 2% | 9.4, 2% | 16.2, 4% | 10.6, 2% | 23.0, 5% |
| Plasma 2 | 240 | 333.4 | 5.8, 2% | 5.2, 2% | 10.7, 3% | 7.4, 2% | 15.1, 5% |
| Plasma 3 | 240 | 208.6 | 3.0, 1% | 3.2, 2% | 6.6, 3% | 4.9, 2% | 9.3, 5% |
| Plasma 4 | 240 | 107.3 | 1.6, 2% | 1.7, 2% | 3.6, 3% | 2.8, 3% | 5.2, 5% |
| Plasma 5 | 240 | 706.8 | 11.9, 2% | 13.9, 2% | 27.1, 4% | 20.1, 3% | 38.4, 5% |
| Plasma 6 | 240 | 823.9 | 16.3, 2% | 12.7, 2% | 30.3, 4% | 22.3, 3% | 42.9, 5% |
Sample Repeatability (Three Reagent Lots Combined)
Additionally, three lots of the calibrators were tested for precision using three lots of the reagents calibrated with master lot of the calibrators. The calibrators were tested 2 runs per day over 10 working days.
Calibrator Repeatability (Three Reagent Lots and Three Calibrator Lots Combined)
| Calibrator | N | Mean | Within-Run
(SD, %CV) | Between-Run
(SD, %CV) | Between-Lot
(SD, %CV) | Between-Day
(SD, %CV) | Total
(SD, %CV) |
|------------|-----|------|-------------------------|--------------------------|--------------------------|--------------------------|--------------------|
| Level 1 | 360 | 262 | 5.7,2% | 0,0% | 13.3,5% | 12.1,5% | 18.8,7% |
| Level 2 | 360 | 578 | 17.9,3% | 0,0% | 27.9,5% | 22.5,4% | 40.1,7% |
| Level 3 | 360 | 1130 | 21.2,2% | 0,0% | 44.9,4% | 40.4,4% | 64.0,6% |
Two lots of serum based controls were tested in duplicates per run, 2 runs per day for 20 days using two lots of the reagents.
8
| Sample | Mean
(N=160) | Within-Run | | Between-Run | | Between-Lot | | Between-Day | | Total | |
|---------|-----------------|------------|-----|-------------|-----|-------------|-----|-------------|-----|-------|-----|
| | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Level 1 | 173.2 | 2.3 | 1 | 1.4 | 1 | 4.1 | 2 | 3.1 | 2 | 4.1 | 2 |
| Level 2 | 607.5 | 8.2 | 1 | 6.5 | 1 | 15.1 | 3 | 11.1 | 2 | 15.2 | 3 |
Control Repeatability (Two Reagent Lots and One Control Lot Combined)
Multi-site precision (reproducibility) study was performed at two external sites and Diazyme site on Modular P analyzer. In this study, the same sets of 6 citrated plasma samples as used. Six citrated plasma including one sample close to the very low end of the AMR and one sample close to the high end of the AMR were tested. The results of the within-run, between-run, between-day, between-site and total CV% are listed in the following tables
Reproducibility Data Analysis (Three Sites, Three Calibrator and Control Lots combined)
| Sample | N | Mean | With-in | Between run | Between day | Between Site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mg/dL | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||
| Plasma 1 | 60 | 408.5 | 10.2 | 3% | 8.8 | 2% | 27.5 | 7% | 29.9 | 7.3% | 42.8 | 10% |
| Plasma 2 | 60 | 303.1 | 6.2 | 2% | 2.3 | 1% | 21.1 | 7% | 21.6 | 7.1% | 30.9 | 10% |
| Plasma 3 | 60 | 195.5 | 2.9 | 2% | 1.8 | 1% | 9.6 | 5% | 9.9 | 5.1% | 14.2 | 7% |
| Plasma 4 | 60 | 100.0 | 1.2 | 1% | 1.1 | 1% | 5.0 | 5% | 5.1 | 5.1% | 7.4 | 7% |
| Plasma 5 | 60 | 701.5 | 22.4 | 3% | 23.8 | 3% | 29.9 | 4% | 43.9 | 6.2% | 62.2 | 9% |
| Plasma 6 | 60 | 818.4 | 13.6 | 2% | 7.7 | 1% | 9.1 | 1% | 18.0 | 2.2% | 25.5 | 3% |
| Calibrator1 | 120 | 250.7 | 3.8 | 2% | 6.0 | 2% | 11.7 | 5% | 13.6 | 5.4% | 19.3 | 8% |
| Calibrator2 | 120 | 502.1 | 11.0 | 2% | 10.9 | 2% | 14.0 | 3% | 20.8 | 4.1% | 29.5 | 6% |
| Calibrator3 | 120 | 1077.3 | 17.1 | 2% | 14.9 | 1% | 47.0 | 4% | 51.8 | 4.8% | 73.5 | 7% |
| Control 1 | 120 | 179.4 | 3.2 | 2% | 1.9 | 1% | 6.1 | 3% | 7.1 | 4.0% | 10.0 | 6% |
| Control 2 | 120 | 609.6 | 13.2 | 2% | 12.6 | 2% | 16.4 | 3% | 24.4 | 4.0% | 34.6 | 6% |
Linearity
The eleven levels linearity set was prepared by mixing a pooled fibrinogen spiked plasma sample containing 1000 mg/dL fibrinogen and saline at different proportions according to Clinical and Laboratory Standards Institute EP6-A. The results showed that Diazyme Fibrinogen Assay is linear up to 1032.8 mg/dL. Based on linearity data. method comparison data, and limit of quantitation (LOQ = 12.9 mg/dL) study, and reference interval study, and predicate AMR, the analytical measuring range (AMR) of Diazyme Fibrinogen assay is claimed to be 100-900 mg/dL.
Method Comparison
Human plasma samples were tested with the Diazyme Fibrinogen Assay and the obtained results were compared to the predicate method according to CLSI EP9-A2 guideline. A total of 176 samples tested across 3 clinical sites. All samples were tested in singlet with both methods. The results are summarized in the following table:
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| Parameter | Regular Regression | Deming regression |
|---|---|---|
| n | 176 | 176 |
| Slope | 0.986 | 0.989 |
| 95% CI | 0.975 – 0.997 | 0.978 – 0.999 |
| Intercept | 2.72 | 1.80 |
| 95% CI | -1.70 - 7.13 | -2.68 - 6.22 |
| Standard Error of Estimate | 15.31 | 15.32 |
| Correlation Coefficient(R) | 0.9973 | 0.9973 |
| Sample Range (Diazyme) | 107.5 - 870.0 | 107.5 - 870.0 |
Interference
The following substances normally present in the plasma produced less than 10% deviation when tested at levels equal to the concentrations listed below, according to CLIA EP7-A "Interference Testing in Clinical Chemistry".
The following endogenous substances do not interfere with this assay at the levels tested (less than 10% bias).
| Interferent | Concentration | |
|---|---|---|
| Ascorbic Acid | 176 mg/dL | |
| Bilirubin | 40 mg/dL | |
| Bilirubin Conjugated | 40 mg/dL | |
| Hemoglobin | 1000 mg/dL | |
| Rheumatoid Factor | 220 IU/ml | |
| Triglycerides | 1000 mg/dL |
The common therapeutic substances of Acetylsalicyclic Acid, Na2-Cefoxitin, Ibuprofen, fibrin degradation product and coagulation inhibitors such as warfarin, dabigatran, hirudin, rivaroxaban, and argatroban, heparin showed no significant interference (