(28 days)
K/DEN number: K070927
No
The description details a standard immunoassay based on latex agglutination and optical density measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The "clinical pretest probability (PTP) assessment model" is a separate clinical tool, not part of the device itself.
No
This device is for in vitro diagnostic use, specifically for quantitative determination of D-Dimer in human plasma to exclude venous thromboembolism. It is not used for direct treatment or therapy.
Yes
The device is explicitly stated as being used "to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)," which is a diagnostic purpose to aid in determining the presence or absence of a medical condition.
No
The device description clearly states it is a "Latex Reagent" which is a physical substance used in an immunoassay, indicating it is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use." This is the primary indicator that the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The description of the device and its function (measuring D-Dimer in human plasma) further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)
For in vitro diagnostic use.
Product codes
DAP
Device Description
The D-Dimer HS Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F(ab')2 fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the D-Dimer HS kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted
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
Not Found
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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2015
INSTRUMENTATION LABORATORY CO. NIKITA MALLADI REGULATORY AFFAIRS SPECIALIST 180 HARTWELL ROAD BEDFORD, MA 01730
Re: K151534
Trade/Device Name: HemosIL D-Dimer HS Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: II Product Code: DAP Dated: June 5, 2015 Received: June 8, 2015
Dear Ms. Malladi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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
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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 regulations (21 CFR Parts 801 and 809), 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" (21 CFR 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
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Indications for Use
510(k) Number (if known)
K151534
Device Name HemosIL D-Dimer HS
Indications for Use (Describe)
Hemos!L D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)
For in vitro diagnostic use.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
| Submitter's Information | Instrumentation Laboratory (IL) Co.
180 Hartwell Road
Bedford, MA 01730, USA | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Nikita Malladi, Regulatory Affairs Specialist II
Phone: 781-674-3245
Fax: 781-861-4207
Email: nmalladi@ilww.com | |
| Preparation Date | June 5, 2015 | |
| Device Trade Name | HemosIL D-Dimer HS | |
| Regulatory Information | Classification: Class II
Regulation No.: 21 CFR 864.7320
Common Name: Fibrinogen and Fibrin split products, Antigen, Antiserum, Control
Panel: Hematology (81)
Product Code: DAP | |
| Predicate Device | HemosIL D-Dimer HS 510(k) No.: K070927 | |
| Device Indications for Use /
Intended Use | HemosIL D-Dimer HS is an automated latex enhanced immunoassay
for the quantitative determination of D-Dimer in human citrated
plasma on the ACL TOP for use in conjunction with a clinical pretest
probability (PTP) assessment model to exclude venous
thromboembolism (VTE) in outpatients suspected of deep venous
thrombosis (DVT) and pulmonary embolism (PE)
For in vitro diagnostic use. | |
| Device Description | The D-Dimer HS Latex Reagent is a suspension of polystyrene latex
particles of uniform size coated with the F(ab')2 fragment of a
monoclonal antibody highly specific for the D-Dimer domain
included in fibrin soluble derivatives. The use of the F(ab')2
fragment allows a more specific D-Dimer detection avoiding the
interference of some endogenous factors like the Rheumatoid
Factor. When a plasma containing D-Dimer is mixed with the Latex
Reagent and the Reaction Buffer included in the D-Dimer HS kit, the
coated latex particles agglutinate. The degree of agglutination is
directly proportional to the concentration of D-Dimer in the sample
and is determined by measuring the decrease of the transmitted | |
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Comparison to Predicate:
This Special 510(k) is being submitted to add general information from peer-reviewed published literature to the Summary and Principle section of the HemoslL D-Dimer HS insert sheet regarding the association of patient age with D-Dimer levels.
The submission meets the criteria for a Special 510(k) based on the following:
- No change in indications for use or intended use
- No change in operating principle
- No change to labeled performance claims, including no change to the assay cut-off ●
- . No change to stability claims or to storage instructions
- No change to reagent preparation
- No change to specimen collection and preparation
- No change to formulation or materials
- No change to data reduction software
- No change to test parameters
- No change to calibration
- . No change to quality controls
Following is a description of the similarities and differences between the currently marketed HemosIL D-Dimer HS (K070927) and HemosIL D-Dimer HS with the insert sheet modifications:
| Similarities | ||
|---|---|---|
| Item | Predicate (K070927) | Modified Device |
| Indications for Use | HemosIL D-Dimer HS is an automated | |
| latex enhanced immunoassay for the | ||
| quantitative determination of D-Dimer | ||
| in human citrated plasma on the ACL | ||
| TOP Family for use in conjunction with a | ||
| clinical pretest probability | ||
| (PTP) | ||
| assessment model to exclude venous | ||
| thromboembolism (VTE) in outpatients | ||
| suspected of deep venous thrombosis | ||
| (DVT) and pulmonary embolism (PE). | Same | |
| Analyte | D-Dimer | Same |
| Methodology | Latex-enhanced immuoturbidimetric | |
| assay | Same | |
| Analyzers | ACL TOP Family | Same |
| Sample Type | Citrated Plasma | Same |
| Cut-off | 230 ng/mL | Same |
| Linearity | 150 – 69000 ng/mL | Same |
| Detection Limit | 21 ng/mL | Same |
| Performance Claims | No change to labeled performance claims | Same |
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Comparison to Predicate (Cont.):
| Differences | ||
|---|---|---|
| Item | Predicate (K070927) | Modified Device |
| Insert Sheet | ||
| Summary and Principle | ||
| Section | Current insert language: |
Elevated levels of D-Dimer are
found in clinical conditions suchas deep vein thrombosis (DVT),
pulmonary embolism (PE) and
disseminated intravascular
coagulation (DIC).
D-Dimer levels also rise during
the normal pregnancy, but very
high levels are associated with
complications. | Insert revisions in italic :
Elevated levels of D-Dimer are
found in clinical conditions such as
deep vein thrombosis (DVT),
pulmonary embolism (PE) and
disseminated intravascular
coagulation (DIC).
D-Dimer levels also rise with age,
and during the normal pregnancy,
but very high levels are associated
with complications.
Further, age-adjusted cut-off values
for DVT and PE suspicion have been
shown to increase the specificity of
D-Dimer and reduce the number of
unnecessary imaging studies in
patient populations greater than 50
years.
NOTE: Bibliography in insert
updated with applicable
supporting references. |
Conclusion:
HemosIL D-Dimer HS, with the modified Summary and Principle insert section, is substantially equivalent to the legally marketed predicate device FDA cleared under K070927.