(61 days)
Not Found
No
The device description details a turbidimetric immunoassay based on latex particle agglutination, which is a standard laboratory technique and does not involve AI/ML. The mention of a "clinical pretest probability (PTP) assessment model" is a separate clinical tool used in conjunction with the D-Dimer result, not a component of the device itself.
No
This device is an in vitro diagnostic immunoassay that quantitatively determines D-Dimer levels to help exclude venous thromboembolism; it does not treat or alleviate a disease or condition.
Yes.
The device is intended for the quantitative determination of D-Dimer in human plasma for use in conjunction with a clinical pretest probability assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE). This indicates its use in aiding in the diagnosis or exclusion of a medical condition.
No
The device description clearly outlines a physical reagent kit (Latex Reagent, Reaction Buffer) used in conjunction with automated laboratory systems (ACL TOP® Family and ACL TOP Family 50 Series Systems) to perform a turbidimetric immunoassay. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use." in the Intended Use / Indications for Use section.
- The device is used for the quantitative determination of D-Dimer in human citrated plasma, which is a biological sample tested in vitro (outside the body).
- The device description details a laboratory-based immunoassay process.
N/A
Intended Use / Indications for Use
HemosIL D-Dimer HS 500 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 Systems 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 500 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 HemosIL D-Dimer HS 500 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 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
Not Found
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)
Not Found
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, formed by three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2017
Instrumentation Laboratory Co. Shajunath Nirupama Regulatory Affairs Specialist I 180 Hartwell Road Bedford, MA 01730
Re: K172903
Trade/Device Name: HemosIL D-Dimer HS 500 Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP Dated: October 26, 2017 Received: October 27, 2017
Dear Ms. Nirupama:
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 yours.
Leonthena R. Carrington -S
Lea Carrington 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) K172903
Device Name
HemosIL, D-Dimer HS 500
Indications for Use (Describe)
HemosIL D-Dimer HS 500 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 Systems 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 | Shajunath Nirupama,
Regulatory Affairs Specialist I
Phone: 781-861-4083
Fax: 781-861-4207
Email: snirupama@ilww.com |
| Preparation Date | November 17, 2017 |
| Device Trade Name | HemosIL D-Dimer HS 500 |
| 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 500 510(k) No: K090264 |
| Device Indications for Use /
Intended Use | HemosIL D-Dimer HS 500 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 Systems 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 500 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 HemosIL D-Dimer HS 500 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 transmitted light
caused by the aggregates (turbidimetric immunoassay). |
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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 HemosIL D-Dimer HS 500 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:
- ん No change in indications for use or intended use
- Σ No change in operating principle
- Σ No change to labeled performance claims, including no change to the assay cut-off
- と No change to stability claims or to storage instructions
- Σ No change to reagent preparation
- ル No change to specimen collection and preparation
- 2 No change to formulation or materials
- ) No change to data reduction software
- No change to test parameters A
- No change to calibration 人
- No change to quality controls
Following is a description of the similarities and differences between the currently marketed HemosIL D-Dimer HS 500 (K090264) and HemosIL D-Dimer HS 500 with the insert sheet modifications:
| Similarities | ||
|---|---|---|
| Item | Predicate (K090264) | Modified Device |
| Indications for Use | HemosIL D-Dimer HS 500 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 Systems 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 | Same | |
| Analyte | D-Dimer | Same |
| Methodology | Latex-enhanced immunoturbidimetric assay | Same |
| Analyzers | ACL TOP Family and ACL TOP Family 50 Series | Same |
| Sample Type | Citrated Plasma | Same |
| Cut-off | 500 ng/mL | Same |
| Linearity | 215 - 128000 ng/mL | Same |
| Detection Limit | 203 ng/mL | Same |
| Performance Claims | No change to labeled performance claims |
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Comparison to Predicate (Cont.):
| Differences | ||
|---|---|---|
| Item | Predicate (K090264) | Modified Device |
| Insert Sheet | Current insert language | Insert revisions in italic |
| Summary and Principle | ||
| (Insert Section) | 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 during | ||
| normal pregnancy but very high | ||
| levels are associated with | ||
| complications. | 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 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 | ||
| 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. | ||
| Limitations/Interfering | ||
| Substances | ||
| (Insert Section) | Specimens from patients who | |
| have received preparation of | ||
| mouse monoclonal antibody for | ||
| diagnosis or therapy may | ||
| contain human anti-mouse | ||
| antibody (HAMA). The presence | ||
| of HAMA may cause an over- | ||
| estimation of results in | ||
| immunoassays that utilize | ||
| mouse monoclonal antibodies. | ||
| The Reaction Buffer contains a | ||
| blocking agent against HAMA to | ||
| minimize this interference on | ||
| the assay results. | Specimens from patients who have | |
| received preparation of mouse | ||
| monoclonal antibody for diagnosis | ||
| or therapy may contain human | ||
| anti-mouse antibody (HAMA). The | ||
| presence of HAMA may cause an | ||
| over-estimation of results in | ||
| immunoassays that utilize mouse | ||
| monoclonal antibodies. The | ||
| Reaction Buffer contains a blocking | ||
| agent against HAMA to minimize | ||
| this interference on the assay | ||
| results. | ||
| The performance of this assay has | ||
| not been validated for use with | ||
| age-adjusted cut-off values. |
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Conclusion:
HemosIL D-Dimer HS 500, with the modified Summary and Principle and Limitations/Interfering Substances insert sections, is substantially equivalent to the legally marketed predicate device FDA cleared under K090264.