(307 days)
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No
The description details a standard automated immunoassay technique (ELFA) and mentions results being calculated based on a stored calibration curve, which is a typical function of such instruments, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is an in vitro diagnostic (IVD) test, used to measure fibrin degradation products in human plasma to help exclude DVT and PE. It is used for diagnostic purposes by providing information for a clinical assessment model, rather than directly treating or preventing a disease.
Yes
The device performs an automated quantitative test to determine fibrin degradation products in human plasma, which is used in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE). This is a diagnostic function, as it aids in identifying or ruling out medical conditions.
No
The device description clearly outlines a system that includes physical components like Solid Phase Receptacles (SPRs) and reagent strips (STRs), and performs automated steps involving sample handling, washing, and fluorescent detection using an instrument. This indicates a hardware-based system, not a software-only device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma". This involves testing a biological sample (plasma) outside of the body to gain information about a patient's health status (to exclude DVT and PE).
- Device Description: The description details an "automated quantitative test" that uses an "ELFA technique" on "human plasma". This clearly describes a laboratory-based test performed on a biological specimen.
- Assay Principle: The description of the assay principle, involving a "two-step enzyme immunoassay sandwich method with a final fluorescent detection," further confirms it's a laboratory diagnostic test.
- Sample Type: The device uses "human plasma," which is a biological sample.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay). VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
Product codes
DAP
Device Description
The VIDAS® D-Dimer Exclusion II assay is an automated quantitative test for use on the instruments of the VIDAS family for the determination of fibrin degradation products (FbDP) in human plasma (sodium citrate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times.
First, the sample is taken by the SPR, diluted and then cycled in and out of the SPR several times. The antigen binds to the anti-FbDP immunodobulins coated on the SPR. Unbound components are eliminated during a washing step. In the second step, the conjugate that contains an alkaline phosphatase labeled anti-FbDP monoclonal antibody is cvcled in and out of the SPR to form a sandwich. Unbound components are eliminated during the washing steps.
A detection step is then performed. The substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm. The intensity of fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory. The results are then printed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JUL 3 1 2012
VIDAS® D-Dimer Exclusion II Assay
Traditional 510(k) Submission
Image /page/0/Picture/4 description: The image shows the logo for bioMérieux. The logo consists of a circle that is divided into two halves, with the left half having horizontal lines and the right half being solid black. The text "BIOMÉRIEUX" is written in all caps below the circle.
510(k) Summary
July 12, 2012
510(k) SUMMARY
VIDAS® D-Dimer Exclusion II Assay
A. Submitter Information
Submitter's Name: bioMérieux, Inc.
| II. | Address: | 595 Anglum Road
Hazelwood, MO 63042 |
|-----|-------------------------------|----------------------------------------------------------------------------------|
| | Contact Person: | John Albright |
| | Phone Number: | 314-731-8546 |
| | Fax Number: | 314-731-8689 |
| | Date of Preparation: | September 2011 |
| | B. Device Name
Trade Name: | VIDAS® D-Dimer Exclusion II Assay |
| | Common Name: | D-Dimer Exclusion II Assay |
| | Classification Name: | 21 CFR 864.7320 Product Code DAP
Fibrinogen/fibrin degradation products assay |
C. Predicate Device Name Trade Name:
VIDAS® D-Dimer Exclusion Assay
D. Device Description
The VIDAS® D-Dimer Exclusion II assay is an automated quantitative test for use on the instruments of the VIDAS family for the determination of fibrin degradation products (FbDP) in human plasma (sodium citrate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times.
1
BIME REETIX
, l
Traditional 510(k) Submission
510(k) Summarv
First, the sample is taken by the SPR, diluted and then cycled in and out of the SPR several times. The antigen binds to the anti-FbDP immunodobulins coated on the SPR. Unbound components are eliminated during a washing step. In the second step, the conjugate that contains an alkaline phosphatase labeled anti-FbDP monoclonal antibody is cvcled in and out of the SPR to form a sandwich. Unbound components are eliminated during the washing steps.
A detection step is then performed. The substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm. The intensity of fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory. The results are then printed.
E. Intended Use
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay). VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical probability assessment model to exclude deep yein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the current assay, VIDAS D-Dimer Exclusion II (ref. 30445) and the predicate assay VIDAS D-Dimer Exclusion (K040882) ref. 30442 is presented in the table below.
2
Image /page/2/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a circle that is half black and half white with vertical lines. The text "BIO M É RIE U X" is below the circle.
Traditional 510(k) Submission
510(k) Summary
| III.
Item | VIDAS® D-Dimer Exclusion II Assay | VIDAS® D-Dimer Exclusion Assay
(K040882) - Predicate | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | | |
| Intended Use | VIDAS® D-Dimer Exclusion II™ is an
automated quantitative test for use on
the instruments of the VIDAS family for
the immunoenzymatic determination of
fibrin degradation products (FbDP) in
human plasma (sodium citrate) using
the ELFA technique (Enzyme Linked
Fluorescent Assay). VIDAS D-Dimer
Exclusion II is indicated for use in
conjunction with a clinical pretest
probability assessment model to
exclude deep vein thrombosis (DVT)
and pulmonary embolism (PE) disease
in outpatients suspected of DVT or PE. | VIDAS D-Dimer Exclusion is an
automated quantitative test for use on
the VIDAS instruments for the
Immunoenzymatic determination of
fibrin degradation products (FbDP) in
human plasma (sodium citrate) using
the ELFA technique (Enzyme-Linked
Fluorescent Assay). VIDAS D-Dimer
Exclusion is indicated for use in
conjunction with a clinical pretest
probability assessment model to
exclude deep vein thrombosis (DVT)
and pulmonary embolism (PE)
disease in outpatients suspected of
DVT or PE. | |
| Assay Technique | Enzyme-linked fluorescent assay
(ELFA) | Enzyme-linked fluorescent assay
(ELFA) | |
| Automated | Yes | Yes | |
| Assay Duration | 19 minutes, 57 seconds | 35 minutes, 35 seconds | |
| SPR | Coating solution includes Anti-FbDP
monoclonal mouse antibodies
No preservative | Coating solution includes Anti-FbDP
monoclonal mouse antibodies
Buffer preservative=azide | |
| Strip | Conjugate includes alkaline
phosphatase-labeled anti-FbDP
monoclonal immunoglobulins (mouse)
MIT or MIT + BND (Wells 5-9 replaced
sodium azide with MIT or MIT+ BND).
Sodium azide only remains in well 10.
Conjugate buffer contains
Non specific Purified mouse IgG*
Nonirradiated de-complemented horse | Conjugate includes alkaline
phosphatase-labeled anti-FbDP
monoclonal immunoglobulins (mouse)
Preservative = azide (Wells 5-10
contain sodium.azide as the
preservative)
Conjugate buffer contains
Non specific Mouse ascite Tg180
Conjugate buffer includes de-
complimented irradiated or non | |
| Calibrators and
Controls
Approximate
target (ng/mL) | serum
S1: 3000-3500
S2=N/A
C1 : 5200-6040
C2 : 250-380
Allows reconstitution with water | irradiated horse serum
S1 : 3700-4400
S2 : 420-580
C1 : 4200-4800
C2 : 380-520
Reconstituted with the R1 diluent
included in the kit | |
| | Recalibration frequency=28 days | Recalibration frequency=14 days | |
| Sample type | Citrated or CTAD plasma | Citrated plasma | |
| Analytical Performance Comparison | | | |
| IV. | Item | VIDAS® D-Dimer Exclusion II Assay | VIDAS® D-Dimer Exclusion Assay (K040882) - Predicate |
| | Assay range | 45-10,000 ng/mL | 45-10,000 ng/mL |
| | Clinical Cut Off | 500 ng/mL | 500 ng/mL |
| | Linearity | 45-10,000 ng/mL | 45-5,000 ng/mL |
| | Detection Limit | ≤ 45 ng/mL | ≤ 45 ng/mL |
| | Hook Effect | 400,000 ng/mL | 400,000 ng/mL |
| Specificity | Fibrinogen (