(225 days)
Not Found
No
The description details a standard immunoassay based on light transmission and agglutination, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an immunoassay designed to quantify von Willebrand Factor Antigen in plasma, which is a diagnostic tool, not a device used for therapy or treatment.
Yes
The device is an "immunoassay for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma." This measurement of a biomarker (VWF:Ag) in a human sample (plasma) for diagnostic purposes (implied by "determination" and testing for a factor related to a medical condition) classifies it as a diagnostic device.
No
The device is a kit containing reagents (Latex Reagent and Reaction Buffer) for a laboratory assay, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma". This indicates it's used to analyze a sample taken from the human body (plasma) to provide information about a specific substance (VWF:Ag).
- Device Description: The description details a "latex particle enhanced immunoturbidimetric assay" that measures the concentration of VWF:Ag in plasma. This is a laboratory-based test performed on a biological sample.
- Predicate Device: The mention of a predicate device (K992704; HemosIL von Willebrand Factor Antigen) which is also an IVD, further supports that this device falls under the same category.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits this definition by providing quantitative information about VWF:Ag in plasma, which can be used in the diagnosis or assessment of conditions related to von Willebrand Factor.
N/A
Intended Use / Indications for Use
Automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma on IL Coagulation Systems.
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
The VWF:Ag kit is a latex particle enhanced immunoturbidimetric assay to quantify VWF:Ag in plasma. When a plasma containing VWF:Ag is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of VWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
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.)
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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
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 19, 2020
Instrumentation Laboratory Co. Nikita Malladi Principal Regulatory Affairs Specialist 180 Hartwell Road Bedford, Massachusetts 01730
Re: K200033
Trade/Device Name: HemosIL von Willebrand Factor Antigen Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: July 17, 2020 Received: July 20, 2020
Dear Nikita 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200033
Device Name
HemosIL von Willebrand Factor Antigen
Indications for Use (Describe)
Automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma on IL Coagulation Systems.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Instrumentation Laboratory, which is a Werfen Company. The logo consists of a graphic element on the left and the company name on the right. The graphic element is made up of two overlapping shapes in green and blue. The text "Instrumentation Laboratory" is in a dark gray sans-serif font, with "A Werfen Company" in a smaller font size below.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 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 | Nikita Malladi, Principal Regulatory Affairs Specialist |
|---|---|
| Phone: 781-674-3245 | |
| Fax: 781-861-4207 | |
| Email: nmalladi@ilww.com |
| Preparation Date | August 4, 2020 |
|---|---|
| ------------------ | ---------------- |
| Device Trade Name | HemosIL von Willebrand Factor Antigen |
|---|---|
| ------------------- | --------------------------------------- |
| Regulation Number | 21 CFR 864.7290 | |
|---|---|---|
| Regulation Description | Factor Deficiency Test | |
| Regulatory Information | Classification | Class II |
| Product Code | GGP | |
| Classification Panel | Hematology (81) |
| Predicate Device | K992704 | HemosIL von Willebrand Factor
Antigen |
| ------------------ | --------- | ------------------------------------------ |
|---|
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| Device Description | The VWF:Ag kit is a latex particle enhanced immunoturbidimetric
assay to quantify VWF:Ag in plasma. When a plasma containing
VWF:Ag is mixed with the Latex Reagent and the Reaction Buffer
included in the kit, the coated latex particles agglutinate. The
degree of agglutination is directly proportional to the
concentration of VWF:Ag in the sample and is determined by
measuring the decrease of transmitted light caused by the
aggregates. |
| -------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Intended Use/
Indications for Use | Automated latex enhanced immunoassay for the quantitative
determination of von Willebrand Factor Antigen (VWF:Ag) in
human citrated plasma on IL Coagulation Systems. |
| -------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| | The claim for Rheumatoid Factor in the “Limitations/Interfering
substances” section of the HemosIL von Willebrand Factor Antigen
insert sheet is being modified as follows: | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Current Insert Claim | Modified Insert Claim |
| Description of the Modification | The presence of Rheumatoid
Factor may produce an
overestimation of VWF:Ag
results on ACL Family Systems.
VWF:Ag results on ACL TOP
Family and ACL TOP Family 50
Series are not affected by
Rheumatoid Factor up to 750
IU/mL. | VWF:Ag results on ACL Family
Systems are not affected by
Rheumatoid Factor up to 50
IU/mL.
VWF:Ag results on ACL TOP
Family and ACL TOP Family 50
Series are not affected by
Rheumatoid Factor up to 50
IU/mL. |
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| Reason Submission
Qualifies as Special 510(k) | This submission for the Hemosll von Willebrand Factor Antigen
meets the criteria for a Special 510(k) outlined in the FDA guidance
"The Special 510(k) Program: Guidance for Industry and Food and
Drug Administration Staff" (September 13, 2019) based on the
following: |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • The proposed change is submitted by the manufacturer legally
authorized to market the existing device. |
| | • Performance data are unnecessary since the current
Rheumatoid Factor claim in the HemosIL von Willebrand
Factor Antigen insert is being replaced with a limitation and a
supporting literature reference. |
| | In addition, the change described in this submission does not
introduce: |
| | • Changes to indications for use or intended use |
| | • Changes to operating principle |
| | • Changes to assay formulation |
| | • Changes to analytical performance claims, except to
Rheumatoid Factor interference claim |
| | • Changes to assay algorithms or data reduction software |
| Design Control Activities | The Rheumatoid Factor interference claim in the HemosIL von
Willebrand Factor Antigen insert sheet is being modified to indicate
that VWF:Ag results on ACL Family Systems, ACL TOP Family and ACL
TOP Family 50 Series are not affected by Rheumatoid Factor up to | 50 IU/mL. |
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------- |
|---|
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| Comparison to Predicate | ||
|---|---|---|
| Similarities | ||
| Item | Predicate (K992704) | Modified Device |
| Intended Use | Automated latex enhanced immunoassay | |
| for the quantitative determination of von | ||
| Willebrand Factor Antigen (VWF:Ag) in | ||
| human citrated plasma on IL Coagulation | ||
| Systems. | Same | |
| Measurand | von Willebrand Factor Antigen | Same |
| Type of Test | Latex immunoassay | Same |
| Methodology | The VWF:Ag kit is a latex particle enhanced | |
| immunoturbidimetric assay to quantify | ||
| VWF:Ag in plasma. When a plasma | ||
| containing VWF:Ag is mixed with the Latex | ||
| Reagent and the Reaction Buffer included in | ||
| the | ||
| kit, the coated latex particles | ||
| agglutinate. The degree of agglutination is | ||
| directly proportional to the concentration | ||
| of VWF:Ag in the sample and is determined | ||
| by measuring the decrease of transmitted | ||
| light caused by the aggregates. | Same | |
| Sample Type | Citrated Plasma | Same |
| Kit Composition | Latex Reagent: 2 vials x 3 mL of a suspension | |
| of polystyrene latex particles coated with a | ||
| rabbit polyclonal antibody directed against | ||
| VWF containing bovine serum albumin, | ||
| buffer, stabilizer and preservative. | ||
| Reaction Buffer: 2 vials x 4 mL of HEPES | ||
| buffer containing bovine serum albumin, | ||
| stabilizers and preservative. | Same | |
| Differences | ||
| Current Insert Claim | Modified Insert Claim | |
| Limitations/Interfering | ||
| Substances | The presence of Rheumatoid Factor | |
| may produce an overestimation of | ||
| VWF:Ag results on ACL Family | ||
| Systems. |
VWF:Ag results on ACL TOP Family
and ACL TOP Family 50 Series are
not affected by Rheumatoid Factor
up to 750 IU/mL. | VWF:Ag results on ACL Family
Systems are not affected by
Rheumatoid Factor up to 50 IU/mL.
VWF:Ag results on ACL TOP Family
and ACL TOP Family 50 Series are not
affected by Rheumatoid Factor up to
50 IU/mL. |
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| Conclusion | HemosIL von Willebrand Factor Antigen and the currently marketed assay
share the same Intended Use/Indications for Use, same operating principle,
same formulation and comparable performance characteristics, except for
the modified claim of no interference from Rheumatoid Factor up to 50
IU/mL. Therefore, HemosIL von Willebrand Factor Antigen with a modified
Rheumatoid Factor interference claim is substantially equivalent to the
currently marketed predicate device FDA cleared under K992704. |
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|