(210 days)
Not Found
No
The document describes a turbidimetric immunoassay for D-Dimer detection and mentions its use in conjunction with a clinical pretest probability model, but does not indicate that the device itself incorporates AI or ML.
No
The device is an in vitro diagnostic immunoassay used to determine D-Dimer levels in plasma, which aids in the diagnosis or exclusion of venous thromboembolism, rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." and describes its use for the "quantitative determination of D-Dimer... to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)." This clearly indicates its role in diagnosing medical conditions.
No
The device description clearly outlines a physical reagent kit (Latex Reagent, Reaction Buffer) used in an in vitro diagnostic assay, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use." in the Intended Use section.
- The device description details an "automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma", which is a classic description of an in vitro diagnostic test performed on a biological sample (plasma) outside of the body.
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 (comma separated list FDA assigned to the subject device)
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 light caused by the aggregates (turbidimetric immunoassay).
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
Not Found
Intended User / Care Setting
Outpatients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Limit of Detection (LoD) claim in the HemosIL D-Dimer HS insert sheet is being updated as follows based on additional testing done to current CLSI EP17-A2 requirements.
Current LoD Claim: 21 ng/mL
Updated LoD Claim: 137 ng/mL
The verification testing to establish the updated Limit of Detection (LoD) claim for the HemosIL D-Dimer HS assay was conducted under design control and in accordance with CLSI EP17-A2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Detection (LoD): 137 ng/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
October 27, 2016
Instrumentation Laboratory Co. Ms. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, MA 01730
Re: K160885
Trade/Device Name: HemosIL D-Dimer HS Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP Dated: September 28, 2016 Received: September 29, 2016
Dear Ms. Marble:
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/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.
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) K160885
Device Name HemosIL D-Dimer HS
Indications for Use (Describe)
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.
| 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
This 510(k) Summary is being submitted in accordance with the requirements of 21 CER 807.92 and the Safe Medical Device Act of 1990.
| Submission Type | Special 510(k) | |
|---|---|---|
| Submitter's Information | Instrumentation Laboratory (IL) Co. | |
| 180 Hartwell Road | ||
| Bedford, MA 01730, USA | ||
| Contact Person | Carol Marble, Regulatory Affairs Director | |
| Phone: 781-861-4467 | ||
| Fax: 781-861-4207 | ||
| Email: cmarble@ilww.com | ||
| Preparation Date | September 28, 2016 | |
| Device Trade Name | HemosIL D-Dimer HS | |
| Regulatory Information | Classification: | |
| Regulation No.: | ||
| Common Name: | ||
| Panel: | ||
| Product Code: | Class II | |
| 21 CFR 864.7320 | ||
| Fibrinogen and Fibrin split products, Antigen, Antiserum, Control | ||
| Hematology (81) | ||
| DAP | ||
| Predicate Device | HemosIL D-Dimer HS | 510(k) No.: K151534 |
| 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 | ||
| light caused by the aggregates (turbidimetric immunoassay). | ||
| 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 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). |
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| Description of the Modification | The Limit of Detection (LoD) claim in the HemosIL D-Dimer HS
insert sheet is being updated as follows based on additional
testing done to current CLSI EP17-A2 requirements. |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Current LoD Claim: 21 ng/mL | Updated LoD Claim: 137 ng/mL |
| Reason Submission Qualifies
as Special 510(k) | 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, except for the LoD
claim based on an additional study |
| | • 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 |
| | The verification testing to establish the updated Limit of Detection
(LoD) claim for the HemosIL D-Dimer HS assay was conducted under
design control and in accordance with CLSI EP17-A2. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Control Activities | Per the Risk Management Report, the proposed change to the LoD
claim does not introduce any additional risk and has no impact on
the safety or effectiveness of the currently marketed device. |
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Comparison to Predicate:
| Similarities | ||
|---|---|---|
| Item | Predicate (K151534) | Modified Device |
| 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 Family and ACL TOP | ||
| Family 50 Series 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 |
| Claimed | ||
| Analyzers | ACL TOP Family: | |
| ACL TOP 300 CTS ACL TOP 500 CTS ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP Family 50 Series: ACL TOP 350 CTS ACL TOP 550 CTS ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS | Same | |
| Sample Type | Citrated Plasma | Same |
| Cut-off | 230 ng/mL | Same |
| Linearity | 150 – 69000 ng/mL | Same |
| Differences | ||
| Detection Limit | 21 ng/mL | 137 ng/mL |