(225 days)
For the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Latex particles of uniform size are coated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-dimer lead to an increase in the turbidity of the test reactants, which can be determined turbidimetrically. The calibrator is D-Dimer calibrator and the recommended control material is D-dimer Control I/II.
Here's an analysis of the provided text regarding the Tina-Quant D-Dimer Test System, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by the study) | Reported Device Performance (Tina-Quant D-Dimer) | Device Meets Criteria? |
|---|---|---|
| DVT Exclusion | ||
| Sensitivity ≥ X% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 99.3% | Yes (based on stated high sensitivity) |
| Negative Predictive Value (NPV) ≥ Y% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 99.4% | Yes (based on stated high sensitivity) |
| Failure Rate ≤ Z% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 0.6% | Yes (based on stated high sensitivity) |
| PE Exclusion | ||
| Sensitivity ≥ A% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 100% | Yes (based on stated high sensitivity) |
| Negative Predictive Value (NPV) ≥ B% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 100% | Yes (based on stated high sensitivity) |
| Failure Rate ≤ C% (not explicitly stated as an AC in the text, but inferred from high sensitivity claim) | 0% | Yes (based on stated high sensitivity) |
Important Note: The provided text describes the results of the studies but does not explicitly state predefined acceptance criteria (e.g., "The device must achieve a sensitivity of at least 95%"). The phrase "excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity" implies that the reported values (99.3%, 99.4%, 0.6% for DVT and 100%, 100%, 0% for PE) met the internal criteria for "high sensitivity."
2. Sample Size Used for the Test Set and Data Provenance
- DVT Exclusion Study:
- Sample Size: 812 outpatients with suspected DVT.
- Data Provenance: Multicenter management study. The country of origin is not specified but is likely within regions where such clinical studies are conducted (e.g., North America, Europe) given the 510(k) submission to the FDA. The study is prospective in nature as patients were followed up for 3 months for development of DVT.
- PE Exclusion Study:
- Sample Size: 168 outpatients with suspected PE.
- Data Provenance: Management study. The country of origin is not specified. The study is prospective in nature as patients were followed up for 3 months for development of PE.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The text does not provide information on the number of experts or their qualifications for establishing the ground truth for the DVT and PE diagnoses. The ground truth (development of DVT or PE) was determined by "further diagnostic testing" (for patients not excluded by D-Dimer and Wells score) and clinical follow-up over 3 months. This typically involves established medical diagnostic procedures and clinical outcomes, implicitly involving medical professionals, but specific details about expert panels are absent.
4. Adjudication Method for the Test Set
The text does not describe an explicit adjudication method (e.g., 2+1, 3+1 for discrepancies) for establishing the ground truth diagnoses of DVT or PE. The studies followed a management strategy:
- Patients with a non-high Wells score and a normal D-Dimer were not subjected to further diagnostic testing but were followed clinically for 3 months.
- Patients who did not meet these exclusion criteria presumably received standard diagnostic workups for DVT/PE which would establish the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The studies described are management studies evaluating the performance of the Tina-Quant D-Dimer test in conjunction with clinical probability assessment (Wells score) for excluding DVT and PE, rather than comparing human reader performance with and without AI assistance. The device itself is an in vitro diagnostic (IVD) test, not an AI imaging or diagnostic algorithm designed to assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, the performance metrics reported (sensitivity, NPV, failure rate) reflect the standalone diagnostic utility of the D-Dimer test when used in conjunction with a clinical probability assessment. The "algorithm" here is the combined clinical probability assessment (Wells score) + D-Dimer cutoff. The reported outcomes (e.g., "Only one of 176 such patients developed DVT") are based on the result of this combined diagnostic strategy, where a particular result (non-high PTP + normal D-Dimer) leads to no further testing and a subsequent clinical follow-up. While there's a human in the loop for the Wells score assessment, the test itself has a standalone numerical result.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / clinical diagnosis, specifically:
- For patients who were not excluded by the D-Dimer + Wells score, the ground truth for DVT/PE would likely be established by conventional diagnostic imaging (e.g., ultrasound for DVT, CTPA for PE).
- For the patients who were excluded (non-high PTP + normal D-Dimer), the ground truth was established by absence of clinical events (DVT/PE) during a 3-month follow-up period. The "failure rate" indicates how many of these excluded patients did develop the condition. This indicates that a combination of clinical outcomes and potentially further diagnostic testing was used for the entire study cohort.
8. Sample Size for the Training Set
The text does not provide information on a training set sample size. This is an in vitro diagnostic (IVD) device, which typically undergoes analytical validation (precision, accuracy, measuring range, etc.) and then clinical validation (as described here). The clinical studies presented are for validation/testing, not for training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for a machine learning context, this question is not applicable based on the provided text. The device is an immunoturbidimetric assay, not an AI/ML diagnostic.
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510(k) Summary
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Ka2203
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3723Contact Person: Theresa Ambrose BushDate Prepared: Nov 3, 2006 |
| Device Name | Proprietary name: Tina-Quant D-Dimer Test System on Roche Hitachi andCOBAS Integra AnalyzersCommon name: D-Dimer Test SystemClassification name: Fibrinogen/Fibrin Degradation Products Assay |
| Description | The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay forthe in vitro quantitative determination of fibrin degradation productsincluding D-Dimer and X-oligomers. Latex particles of uniform size arecoated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimerepitope. The antigen/antibody complexes produced by the addition ofsamples containing D-dimer lead to an increase in the turbidity of the testreactants, which can be determined turbidimetrically. The calibrator is D-Dimer calibrator and the recommended control material is D-dimer ControlI/II. |
| Intended use | for the in vitro quantitative determination of fibrin degradation productsincluding D-Dimer and X-oligomers. In conjunction with a non-high clinicalprobability assessment, a normal (< 0.5 µg FEU/ml) result excludes deepvein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. |
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510(k) Summary, Continued
The Tina-Quant® D-Dimer Test System on the Roche Hitachi and COBAS Substantial equivalence Integra Analyzer is substantially equivalent to other products in commercial distribution. We claim equivalence to the currently marketed Tina-quant® D-Dimer Test System cleared under K030740. For purposes of the intended use extension, we also claim equivalence to the Biomerieux Vidas ® D-Dimer Exclusion Assay, cleared under K040822. The below table compares the modified Tina-Quant® D-Dimer Test System Substantial equivalence on the Roche Hitachi and COBAS Integra Analyzers with the predicate comparison devices, Tina-quant® D-Dimer Test System (K030740) and Biomerieux Vidas ® D-Dimer Exclusion Assay (K040822)
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| Substantial equivalence comparison tableCharacteristic | Modified Device: Tina-Quant®D-Dimer Test System | Predicate deviceTina-Quant® D-Dimer TestSystem (K030740) | Predicate deviceBiomerieux Vidas® D-DimerExclusion Assay (K040822) |
|---|---|---|---|
| Intended Use | For Roche/HitachiImmunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. | For Hitachi: Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers.For COBAS Integra: The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in plasma. | The VIDAS ® D-Dimer Exclusion assay is an automated quantitative test for use on the VIDAS analyzers for the immunoenzymatic determination of fibrin degradation products (FbDP) in citrated human plasma using the ELFA techniques (Enzyme Linked Fluorescent Assay). The VIDAS® D-Dimer Exclusion assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) assessment model to exclude deep venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE. |
| For COBAS Integra : The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in plasma. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. | |||
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ubstantial equivalence comparison table
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| Characteristic | Modified Device: Tina-Quant® D-Dimer Test System | Predicate device Tina-Quant® D-Dimer Test System (K030740) | Predicate device Biomerieux Vidas ® D-Dimer Exclusion Assay (K040822) |
|---|---|---|---|
| Indications for use | For the in vitro quantitative determination of fibrin degradation products including D-dimer and X-oligomers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. | For the in vitro quantitative determination of fibrin degradation products including D-dimer and X-oligomers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation. | For use in conjunction with a clinical Pre-test Probability Assessment (PTP) assessment model to exclude deep venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE. |
| R2 reagent buffer matrix | Anti-D-Dimer latex suspension (0.15%) in pH 7.2 buffer matrix | Anti-D-Dimer latex suspension (0.15%) in Tris buffer pH 8.2 | Not applicable |
| Assay principle | Active ingredients are identical in composition and concentration to predicate device. | Particle-enhanced immunoturbidimetric assay | Two-step enzyme immunoassay sandwich method with a final fluorescent detection.VIDAS instruments |
| Instrument | Same as K030740 | Roche Hitachi family of analyzersCOBAS Integra family of analyzers | Same as K030740 |
| Characteristic | Modified Device: Tina-Quant® D-Dimer Test System | Predicate device Tina-Quant® D-Dimer Test System (K030740) | Predicate device Biomerieux Vidas ® D-Dimer Exclusion Assay (K040822) |
| ReagentStability | Same as K030740 | Roche/Hitachi Unopened: up to stated expiration data at 2-8 oC On board: 28 days opened and refrigerated COBAS Integra Unopened: up to stated expiration data at 2-8 oC Integra 400: On board 12 weeks at 10 -15 oC Integra 700/800: On board 12 weeks at 8 oC | Up to stated expiration date at 2-8 oC |
| Sample type | Same as K030740 | Citrated plasmaLi-Heparin plasma | Trisodium citrate. |
| Traceability/standardization | Same as K030740 | Asserachrom D-Dimer method | unclear |
| Calibrator | Same as K030740 | D-Dimer Calibrator | DD2 Calibrators |
| Quality Control | Same as K030740 | D-Dimer Control I/II | DD2 Controls |
| Substantial Equivalence Comparison Tables (continued) | |||
| Characteristic | Modified Device: Tina-Quant® D-Dimer Test System | Predicate device Tina-Quant® D-Dimer Test System (K030740) | Predicate device Biomerieux Vidas ® D-Dimer Exclusion Assay (K040822) |
| Measuring range | Same as K030740 | Roche/Hitachi0.15-9.0 ug FEU/mL0.15 - 21.0 ug FEU/mL extended range with dilution and rerun | 45-10,000 ng/mL (FEU) |
| COBAS Integra0.15-9.0 ug FEU/mL0.15-54.0 ug FEU/mL extended range with postdilution | |||
| Lower Detection Limit | Same as K030740 | Roche/Hitachi:0.04 ug FEU/mL | <45 ng/mL (FEU) |
| COBAS Integra:<0.08 ug FEU/mL | |||
| Within-run precision (%CV) | Same as K030740 | Roche/Hitachi7.3% at 0.19 ug FEU/mL1.7% at 0.86 ug FEU/mL0.8% at 5.11 FEU/mL | 5.0% at 264 ng/mL (FEU)3.9% at 549 ng/mL (FEU)5.3% at 7283 ng/mL (FEU) |
| COBAS Integra:6.9% at 0.279 ug FEU/mL1.1 % at 2.88 ug FEU/mL | |||
| Between-run/Intra-Assayprecision(%CV) | Same as K030740 | Roche/Hitachi6.5% CV at 0.30 ug FEU/mL8.3% CV at 0.87 ug FEU/mL3.2% CV at 4.58 FEU/mL | 5.70% at 264 ng/mL (FEU)5.8% at 549 ng/mL (FEU)7.1% at 7283 ng/mL (FEU) |
| Between-run/Intra-Assayprecision(%CV) | Same as K030740 | COBAS Integra:6.8% CV at 0.28 ug FEU/mL1.1% CV at 2.89 ug FEU/mLRoche/Hitachi6.5% CV at 0.30 ug FEU/mL8.3% CV at 0.87 ug FEU/mL3.2% CV at 4.58 FEU/mL | 5.70% at 264 ng/mL (FEU)5.8% at 549 ng/mL (FEU)7.1% at 7283 ng/mL (FEU) |
| Limitations:interferences | Same as K030740 | COBAS Integra:6.8% CV at 0.28 ug FEU/mL1.1% CV at 2.89 ug FEU/mLRoche/ HitachiNo significant interference up to I index of 20 (20 mg/dL bilirubin) H index of 500 (500 mg/dL hemoglobin) L index of 750 (intralipid) Rheumatoid factors < 100 IU/mL Heparin < 1.5 IU/mL No interference with 31 frequentlyused pharmaceuticalsNo high dose hook effect up to1000 mg/LIn rare cases, high levels of IgM cangive falsely high results | None of the following factors havebeen found to significantlyinfluence this assay: hemolysis,lipemia, bilirubinemia, rheumatoidfactor.It is recommended not to usesamples that appear to be clearlyhemolyzed, lipemic, or icteric. |
| Characteristic | Modified Device: Tina-Quant® D-Dimer Test System | Predicate device Tina-Quant® D-Dimer Test System (K030740) | Predicate device Biomerieux Vidas ® D-Dimer Exclusion Assay (K040822) |
| Limitations: interferences (continued) | Same as K030740 | High concentrations of D-fragments, as observed during lysis therapy, lead to depressed measurementsFructosamine should be assigned to a higher channel then D-Dimer on Roche/Hitachi analyzersResults should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings. | See above |
| COBAS IntegraNo significant interference up to• H index of 300 (300 mg/dL hemoglobin)• L index of 600 (intralipid)• Rheumatoid factors < 100 IU/mL• Heparin < 1.5 IU/mLNo significant interference from bilirubin or rheumatoid factors. | |||
| Characteristic | Characteristic | Modified Device: Tina-Quant® D-Dimer Test System | Predicate deviceTina-Quant® D-Dimer Test System (K030740) |
| Limitations:interferences(continued) | Same as K030740 | In rare cases, high levels of IgM cangive falsely high results | See above |
| High concentrations of D-fragments, as observed during lysistherapy, lead to depressedmeasurements | |||
| Fructosamine should be assigned toa higher channel then D-Dimer onRoche/Hitachi analyzers | |||
| Results should always be assessedin conjunction with the patient'smedical history, clinicalexamination, and other findings. | |||
| Expected values | Same as K030740 | <0.5 ug/ FEU / mL | Below 500 ng/mL, FEU |
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510(k) Summary, Continued
Substantial Equivalence comparison table (continue
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Submission purpose
The purpose of this submission is to extend the intended use of the Tina-Quant® D-Dimer Test System on the Roche Hitachi and COBAS Integra analyzers to include exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE) exclusion. We also provide notification of a minor change to the reagent formulation (a pH change of the R2 buffer matrix) which has occurred since the device clearance. This change did not result in any labeled performance changes.
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Supporting The change in reagent composition was validated according to design control information procedure.
Published clinical guidelines and several clinical studies exist which demonstrate and support the clinical utility of the Tina-Quant D-Dimer test in the evaluation of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with suspected DVT or PE. A guidelines summary and systematic review of published clinical studies were presented as clinical support for this claim extension. Specific support for the exclusion claim came from two management studies, as follows.
Clinical performance in the exclusion of DVT:
Tina-Quant ® D-Dimer was used in a multicenter management study involving 812 outpatients with suspected DVT . Using the Wells probability assessment score , patients were classified as having a high (>3) or non-high (< 3) pretest probability of DVT. The Tina-Quant® D-Dimer test was then performed using a cutoff of 0.5 ug FEU/ mL. Those patients having a normal (negative) D-Dimer test result and a non-high pretest probability had no further diagnostic testing and were followed up for 3 months for development of DVT. Only one of 176 such patients developed DVT during the follow-up period. The sensitivity, negative predictive value, and failure rate of the Tina-Quant ® D-Dimer assay in conjunction with a non-high pretest probability is summarized below:
| Sensitivity: | 99.3% |
|---|---|
| Negative Predictive Value: | 99.4% |
| Failure Rate: | 0.6%. |
Clinical performance in the exclusion of PE:
Tina-Quant ® D-Dimer was used in a management study involving 168 outpatients with suspected PE . Using the Wells clinical model for PE probability, patients were classified as having a low, moderate, or high pretest probability of PE. The Tina-Quant® D-Dimer test was then performed using a cutoff of 0.5 ug FEU/ mL. Those patients having a normal (negative) D-Dimer test result and a non-high (low or moderate) pretest probability had no further diagnostic testing and were followed up for 3 months for development of PE. No patients developed PE during the follow-up period. The sensitivity, negative predictive value, and failure rate of the Tina-Quant ® D-Dimer assay in conjunction with a non-high pretest probability is summarized below:
| Sensitivity: | 100 % |
|---|---|
| Negative Predictive Value: | 100 % |
| Failure Rate: | 0 %. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
ROCHE DIAGNOSTICS CORP. C/O Theresa Ambrose Bush 9115 Hague Road Indianapolis, Indiana 46250
Re: K062203
Trade/Device Name: Tina-Quant D-Dimer Test System Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: Class II Product Code: GHH Dated: July 31, 2006 Received: August 1, 2006
MAR 1 4 2007
Dear Ms. Bush:
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 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Robert A. Booke, Jr. MD, PhD
Robert L. Becker, Jr., MD, PH Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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and the contraction of the comments of the comments of the contraction of the control of
HFZ-404 510(k) Staff HFZ- 440 Division D.O.
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Indications for Use
510(k) Number (if known):
Device Name: Tina-Quant D-Dimer Test System
Indications For Use:
For Roche/Hitachi Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
For COBAS Integra : The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in plasma. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
§ 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).