(124 days)
The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
STA® - Liatest® D-Di kit contains: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin.
The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.
This document describes the acceptance criteria and study proving the performance of the STA® - Liatest® D-Di kit, an immuno-turbidimetric assay for the quantitative determination of D-dimer.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the STA® - Liatest® D-Di kit were based on achieving specific Negative Predictive Value (NPV) and Sensitivity targets for the exclusion of Pulmonary Embolism (PE) and Deep Venous Thrombosis (DVT) in outpatients with low to moderate pretest probability (PTP).
| Metric | Acceptance Criteria (95% CI) | Reported Device Performance (95% CI) - Overall Study Population |
|---|---|---|
| NPV (for DVT) | ≥ 99.0% (as per CLSI H59-A requirements) | 100.0% (99.3% - 100%) |
| Sensitivity (for DVT) | ≥ 95.0% (as per CLSI H59-A requirements) | 100.0% (95.8% - 100%) |
Note: The document explicitly states that the results "meet both confirmatory hypotheses relating to NPV and Sensitivity." While the predicate device's PE and DVT results are listed in the "Similarities Chart," the detailed performance data for the new device (STA® - Liatest® D-Di) in the clinical performance section is specifically for DVT exclusion. The indications for use state "to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT)", but the detailed study results presented focus on DVT.
2. Sample Size and Data Provenance
- Test Set Sample Size: 980 samples of patients with a low or moderate PTP were included in the primary efficacy analyses. This consisted of 79 suspects of DVT and PE, and 901 suspects of DVT only. Of the 980 samples, 85 were DVT positive and 895 were DVT negative.
- Data Provenance: The data was collected from a prospective, multi-center clinical study conducted at 16 sites across the United States, Europe, and Canada. The patients were consecutive, ambulatory outpatients presenting at emergency units or outpatient clinics suspected of having venous thromboembolism (VTE).
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the "number of experts" or their "qualifications" in the context of establishing ground truth in the traditional sense of human readers adjudicating medical images. Instead, the ground truth was established through a clinical protocol:
- Patients with positive D-dimer results were considered for an imaging procedure (e.g., ultrasound, CT angiography).
- Patients with negative D-dimer results were assigned to a three-month follow-up to confirm the absence of DVT/PE.
- The "Reference" column in the results tables (Tables 1, 2) is a combination of "imaging or 3-month follow-up."
Therefore, the establishment of ground truth was based on clinical diagnostic pathways and follow-up, rather than expert interpretation of a specific dataset for the purpose of algorithm validation in the way one might see for an imaging AI. The "experts" in this context would be the clinicians and radiologists involved in the standard of care diagnostic work-up.
4. Adjudication Method for the Test Set
Not applicable in the typical sense of expert adjudication of AI outputs. The ground truth was established by standard clinical practice: a positive D-dimer result led to imaging, and a negative D-dimer result led to a 3-month clinical follow-up for confirmation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is an in-vitro diagnostic (D-dimer assay), not an imaging AI diagnostic device intended to assist human readers. The study evaluates the standalone performance of the assay in a clinical pathway.
6. Standalone Performance (Algorithm Only without Human-in-the Loop)
Yes, this study represents a standalone (algorithm only) performance evaluation. The STA® - Liatest® D-Di kit itself is the "algorithm" or diagnostic tool, and its performance (sensitivity and NPV) is reported based on its direct results in conjunction with a clinical pretest probability assessment model. Its output (D-dimer level) is then used to guide clinical decisions (imaging vs. observation).
7. Type of Ground Truth Used
The ground truth was established by clinical outcomes data and definitive diagnostic imaging (e.g., ultrasound for DVT, CT angiography for PE) or clinical follow-up confirming the absence of the condition. Specifically, the "Reference" for the test set was determined by "imaging or 3-month follow-up."
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This is common for traditional in-vitro diagnostic assays, where product development and analytical validation are often not described in terms of "training sets" like machine learning models. The study described is primarily a clinical validation study demonstrating performance on a test set.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" (in the context of machine learning) is discussed for this in-vitro diagnostic device, this point is not applicable. The development and analytical validation of such assays typically involve laboratory studies (e.g., linearity, precision, interference) and internal developmental studies that establish the assay's performance characteristics, rather than a "ground truth" derived from a clinical dataset used for training, as would be the case for an AI/ML device.
{0}------------------------------------------------
Image /page/0/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 that resembles a stylized human figure or a group of people in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2016
Diagnostica Stago c/o Carlo d'Alessandro Director, Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10 00153 Rome, Italy
Re: K162227
Trade/Device Name: STA® - Liatest® D-Di Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP Dated: November 7, 2016 Received: November 9, 2016
Dear Mr. d'Alessandro:
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
{1}------------------------------------------------
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/ResourcesforYou/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.
Sincerelv.
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)
Device Name STA® - Liatest® D-Di
Indications for Use (Describe)
The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or hoth, as annlicable)
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image features the logo for Stago, a company specializing in in-vitro diagnostics. The logo consists of the word "Stago" in a red, serif typeface, positioned below a stylized graphic. The graphic is composed of two abstract shapes: one in a reddish-brown hue and the other in a muted gray-brown, arranged to suggest a sense of movement or flow.
510(k) Summary
| Submitter Information: | Diagnostica Stago3, Allée Thérésa92600 Asnières sur Seine, FranceContact name: Mr. Arnaud BerthierMarket Access Operating DirectorTel: +33 1 46 88 21 01 (main)+33 6 85 92 30 82Fax: +33 1 47 33 64 60 |
|---|---|
| Date of Submission: | 05 August 2016 |
| Application Correspondentand Contact Person: | Mr. Carlo d'Alessandro,Director, IVD Quality and RegulatoryDonawa Lifescience Consulting SrlPiazza Albania, 10 - 00153 Rome, ItalyTel: +39 06 578 2665Fax: +39 06 574 3786cdalessandro@donawa.com |
| Device Trade Name: | STA® - Liatest® D-Di |
| Regulatory Information: | |
| Classification Name: | Fibrinogen and fibrin split products, antigen, antiserum, control |
| Regulatory Class: | Class II |
| Panel: | Hematology |
| Product Code: | DAP |
| Regulation Number: | 864.7320 |
| Predicate Device: | VIDAS® D-Dimer Exclusion™ (K040882) |
Device Intended Use:
✔ New Device Intended Use
The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liatest® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with the letters in a dark red color. Above the word "Stago" is an abstract graphic element. The graphic element is composed of two curved shapes, one in a dark red color and the other in a gray color, arranged in a circular fashion.
✓ Previous Device Intended Use
The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® -Liatest® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
Device description:
STA® - Liatest® D-Di kit contains: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin.
The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.
Statement of technological characteristics of the device compared to predicate device:
The STA® - Liatest® D-Di kit and the Vidas® D-Dimer Exclusion™ (K040882) have different assay method and test principle. However, both kits are equivalent considering their intended use for excluding PE and DVT.
| Device | Predicate Device | |
|---|---|---|
| Attributes orcharacteristics | Diagnostica Stago,STA® - Liatest® D-Di | bioMérieux,VIDAS® D-Dimer Exclusion™K040882 |
| Indications forUse | Quantitative determination of D-dimer in venous plasma (in 3.2%sodium citrate) for use on STA-R®,STA Compact® and STA Satellite®analyzers by professional laboratorypersonnel. The STA® - Liatest® D-Diis intended for use in conjunctionwith a clinical pretest probability(PTP) assessment model to excludepulmonary embolism (PE) and deepvenous thrombosis (DVT) inoutpatients suspected of PE or DVT. | Automated quantitative test for useon the VIDAS instruments for theimmunoenzymatic determination offibrin degradation products (FbDP)in human plasma (sodium citrate)using ELFA technique (EnzymeLinked Fluorescent Assay). Theassay is indicated for use inconjunction with a clinical pretestprobability assessment model toexclude deep vein thrombosis (DVT)and pulmonary embolism (PE)disease in outpatients suspected ofPE or DVT. |
| Device | Predicate Device | |
| Attributes orcharacteristics | Diagnostica Stago,STA® - Liatest® D-Di | bioMérieux,VIDAS® D-Dimer Exclusion™K040882 |
| Analyte(s)measured | D-dimer | D-dimer |
| Cut-off | 0.5 µg/mL | 500 ng/mL (same) |
| Clinicalperformances | For exclusion of PE on low andmoderate PTP population (n = 1130):Sensitivity = 97.0% (95% CI: 91.6%- 99.4%)NPV = 99.7% (95% CI: 99.2% -100.0%)For exclusion of DVT on low andmoderate PTP population (n = 980):Sensitivity: 100.0 % (95% CI: 95.8%- 100.0 %)NPV: 100.0 % (95% CI: 99.3 % -100.0 %) | For exclusion of PE on low andmoderate PTP population (n = 891):Sensitivity: 100.0 % (95% CI: 97.7%- 100.0 %)NPV: 100.0 % (95% CI: 98.7 % -100.0 %)For exclusion of DVT on low PTPpopulation (n = 295):Sensitivity: 100.0 % (95% CI: 81.5%- 100.0 %)NPV: 100.0 % (95% CI: 96.7 % -100.0 %)For exclusion of DVT on moderatePTP population (n=189):Sensitivity: 100.0 % (95% CI:80.5% - 100.0 %)NPV: 100.0 % (95% CI: 92.3 % -100.0 %) |
| Anatomical Sites | Not applicable.No direct patient contact. | Not applicable.No direct patient contact. |
| Where Used:Hospital, home,ambulance, etc. | Hospital Laboratory or other HealthCare Laboratory. | Hospital Laboratory or other HealthCare Laboratory. |
| Sterility | No sterility requirements.No direct patient contact. | No sterility requirements.No direct patient contact. |
| Biocompatibility | No biocompatibility requirements.No direct patient contact. | No biocompatibility requirements.No direct patient contact. |
| Chemical Safety | No issues regarding chemical safetydue to no direct patient contact. | No issues regarding chemical safetydue to no direct patient contact. |
Similarities Chart with VIDAS® D-Dimer Exclusion™ (K040882)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Stago. The logo features the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is an abstract graphic element that resembles a stylized leaf or droplet shape. The top part of the shape is a reddish-brown color, while the bottom part is a muted gray-brown color.
Differences Chart with VIDAS® D-Dimer Exclusion™ (K040882)
| Attributes orcharacteristics | Device | Predicate Device |
|---|---|---|
| Contents of theKit | Diagnostica Stago,STA® - Liatest® D-Di | bioMérieux,VIDAS® D-Dimer Exclusion™K040882 |
| Two reagents.6 x 5-ml Vials of Reagent 1 (Buffer) | - DD2 Reagent Strips- ready to use- 2x30 DD2 Solid Phase Receptors |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is an abstract graphic element. The graphic element is composed of two shapes, one red and one gray, that appear to be interlocking or overlapping.
| Device | Predicate Device | |
|---|---|---|
| Attributes orcharacteristics | Diagnostica Stago,STA® - Liatest® D-Di | bioMérieux,VIDAS® D-Dimer ExclusionTMK040882 |
| 6 x 6-ml Vials of Reagent 2 (Latex) | (SPR)- 1 x 25-ml DD2 diluent Vial (liquid)- 3 x 2-ml Vials of C1 and C2control (lyophilized)- 2 x 2-ml Vials of S1 and S2calibrator (lyophilized) | |
| Assay Method | Immuno-turbidimetric method | ELFA technique (Enzyme LinkedFluorescent Assay) |
| Test Principle | Immuno-turbidimetric method basedon the measurement of lightabsorbance (at 540 nm) produced bya suspension of microlatex particlescoated with specific mouse anti-human D-dimer monoclonalantibodies. | The assay combines a two-stepenzyme immunoassay sandwichmethod with a final fluorescentdetection step (ELFA). |
| Analyzers | IVD analyzers of the STA® line. | VIDAS instruments |
Clinical Performance Data:
A clinical multi-center study (16 sites over the United States, Europe and Canada), conducted according to CLSI H59-A, was performed to demonstrate the ability of STA® - Liatest® D-Di to safely rule-out DVT by using samples of prospective, consecutive, ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having venous thromboembolism (VTE).
The study population was recruited from prospective, ambulatory outpatients suspected of having DVT. After consenting, these patients were evaluated using the Wells score as pretest probability (PTP) model:
- -Patients with low or moderate PTP were considered for D-dimer testing:
- those with positive D-dimer result were considered for an imaging procedure ●
- those with negative D-dimer result were considered as not having DVT and . assigned to a three month follow up.
- Patients with high PTP were considered for an imaging procedure and not included in the study's primary analyses.
D-dimer assays were carried out using STA® - Liatest® D-Di on fresh plasma samples or on frozen plasma samples tested within 30 days of blood collection.
For primary efficacy analysis the population of interest was limited to patients with a PTP result low or moderate. In this group, only patients with a negative D-dimer result had a follow up call or visit at 3 months.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with the letters in a reddish-brown color. Above the word is an abstract graphic element, also in reddish-brown and gray. The graphic element appears to be composed of three curved shapes arranged in a circular fashion.
The study product was used in accordance with routine clinical practice and sites used imaging procedures according to standard of care.
Results:
980 samples of patients with a low or moderate PTP were included in the primary efficacy analyses (79 suspects of DVT and PE and 901 suspects of DVT only).
Of the 980 samples, 85 were from DVT positive and 895 from DVT negative patients.
The overall prevalence of DVT (low and moderate PTP patients with positive imaging) in the prospective study population was 8.4 % with 6.0 % in the US population and 9.8% in the European/Canadian ("out of US") population.
Primary efficacy analyses of the study included calculation of two co-primary parameters: Negative Predicted Value (NPV) and Sensitivity which were tested versus four (4) performance goals-two using 95 % two-sided confidence intervals (CI) and two versus point estimates.
All the efficacy parameters with upper and lower limit of 95 % confidence intervals (CI) were calculated in the overall study population, and separately for the US population and the "out of US" population with the STA® - Liatest® D-Di clinical cut-off of 0.50 µg/ml (FEU) in the (low + moderate) PTP group of patients.
Results obtained for each study population are detailed below:
Table 1 Results obtained on the overall prospective study population
| Overall | Reference (imaging or 3-month follow-up) | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| D-dimer | Positive | 85 | 401 | 486 |
| Negative | 0 | 494 | 494 | |
| Total | 85 | 895 | 980 |
Sensitivity (95 % CI) = Specificity (95 % CI) = NPV (95 % CI) = PPV (95 % CI) =
100% (95.8% - 100%) 55.2% (51.9% - 58.5%) 100% (99.3% - 100%) 17.5% (14.2% - 21.2%)
Table 2 Results obtained on the US prospective study population
| Reference (imaging or 3-month follow-up) | ||||
|---|---|---|---|---|
| US | Positive | Negative | Total | |
| D-dimer | Positive | 22 | 145 | 167 |
| Negative | 0 | 202 | 202 | |
| Total | 22 | 347 | 369 |
Sensitivity (95 % CI) = Specificity (95 % CI) = NPV (95 % CI) = PPV (95 % CI) =
100% (84.6% - 100%) 58.2% (52.8% - 63.5%) 100% (98.2% - 100%) 13.2% (8.4% - 19.3%)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a red, serif font. Above the word is an abstract design featuring two curved shapes, one red and one gray, arranged in a circular pattern. The red shape is larger and positioned above the gray shape.
| Out of US | Reference (imaging or 3-month follow-up) | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| D-dimer | Positive | 63 | 256 | 319 |
| Negative | 0 | 292 | 292 | |
| Total | 63 | 548 | 611 |
Sensitivity (95 % CI) = Specificity (95 % CI) = NPV (95 % CI) = PPV (95 % CI) =
100% (94.3%-100%) 53.3% (49.0%-57.5%) 100% (98.7%-100%) 19.7% (15.5%-24.5%)
This study demonstrates that the STA® - Liatest® D-Di is effective in excluding deep venous thrombosis (DVT) in patient with a low or moderate PTP and a D-dimer level < 0.50 µg/ml (FEU) with a NPV of 100.0 % (confidence interval 95 %: 99.3% to 100%) according to CLSI H59-A requirements and with a Sensitivity of 100% (confidence interval 95 %: 95.8% to 100%). These results meet both confirmatory hypotheses relating to NPV and Sensitivity.
§ 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).