(30 days)
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No
The description details a standard immunoturbidimetric assay based on latex particle agglutination and light transmission measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used for the quantitative determination of von Willebrand Factor Antigen. It does not provide therapy or treatment.
Yes
The device quantitatively determines von Willebrand Factor Antigen (VWF:Ag) in human plasma, which is a diagnostic measurement used to assess a patient's health status related to von Willebrand disease or other bleeding disorders. The "Intended Use" specifically states "quantitative determination," indicating it provides data for medical diagnosis.
No
The device is an in vitro diagnostic assay kit, which includes reagents and is used on a coagulation system. This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma." This is a test performed on a biological sample (plasma) outside of the body to provide information about a patient's health status.
- Device Description: The description details an "in vitro diagnostic assay" that uses a "latex particle enhanced immunoturbidimetric assay" to quantify VWF:Ag in plasma. This confirms it's a laboratory test performed on a sample.
- Input Imaging Modality and Anatomical Site: The document explicitly states "Not Applicable (In vitro diagnostic assay)" for these categories, further reinforcing its nature as a test performed on a sample rather than directly on a patient.
The core function of the device is to analyze a biological sample (plasma) to provide diagnostic information (VWF:Ag levels), which is the definition of an In Vitro Diagnostic device.
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
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
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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
The open vial stability study was performed in accordance to an established plan and protocol and design control procedures. Testing verified all acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2022
Instrumentation Laboratory Co. Nikita Malladi Regulatory Affairs Manager I 180 Hartwell Road Bedford, Massachusetts 01730
Re: K223402
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: November 8, 2022 Received: November 9, 2022
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
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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,
Takeesha Taylor-bell -S
Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics 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) K223402
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. The logo consists of a green and blue graphic on the left, followed by the text "Instrumentation Laboratory" in a gray sans-serif font. Below the text is the phrase "A Werfen Company" in a smaller font.
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submission Type | Special 510(k) |
|---|---|
| Submitter's Information | Instrumentation Laboratory Company |
| 180 Hartwell Road | |
| Bedford, MA 01730-2443 (USA) | |
| Contact Person | Nikita Malladi |
| Regulatory Affairs Manager I | |
| Phone: 781-674-3245 | |
| Fax: 781-861-4207 | |
| Email: nmalladi@werfen.com |
| Preparation Date | November 08, 2022 | |
|---|---|---|
| Device Trade Name | HemosIL von Willebrand Factor Antigen | |
| Predicate Device | ||
| and 510(k) Number | HemosIL von Willebrand Factor Antigen | K200033 |
| Regulatory Information | Regulation Section No. | 21 CFR 864.7290 |
|---|---|---|
| Regulation Description | Factor Deficiency Test | |
| Classification | Class II | |
| Product Code | GGP | |
| Classification Panel | Hematology (81) |
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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.
Indications for Use / 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.
Reason Submission Qualifies as Special 510(k)
This Special 510(k) is being submitted to modify the open vial stability labeled claim for HemosIL von Willebrand Factor Antigen from 3 months to 14 days based on testing to the current CLSI EP25-A guideline.
The submission meets the criteria for a Special 510(k) based on the following:
- . The proposed change is submitted by the manufacturer legally authorized to market the existing device.
- . There is a well-established method to evaluate the change: CLSI EP25-A.
- . The data can be reviewed in a summary or risk analysis format.
In addition, the change in this submission does not introduce:
- Changes to indications for use or intended use .
- . Changes to operating principle
- Changes to formulation .
- Changes to labeled performance claims, except to reduce the open vial stability claim to 14 days ●
- Changes to assay algorithms or data reduction software ●
Design Control Activities
The open vial stability study was performed in accordance to an established plan and protocol and design control procedures. Testing verified all acceptance criteria were met.
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| Comparison to Predicate Device | ||
|---|---|---|
| Similarities | ||
| Item | Predicate (K200033) | Subject Device |
| Trade Name | HemosIL von Willebrand Factor Antigen | Same |
| Manufacturer | Instrumentation Laboratory Company | Same |
| 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. | 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 | |
| Instrumentation | ACL Elite / ACL Elite Pro K060162 | |
| ACL TOP Family K160276 | ||
| ACL TOP Family 50 Series K150877 | Same | |
| Comparison to Predicate Device (Cont.) | ||
| Differences | ||
| Item | Predicate (K200033) | Subject Device |
| Reagent Open Vial | ||
| Stability | Current Insert Claim | |
| Opened reagents are stable 3 months at | ||
| 2-8°C in the original vial. | Modified Insert Claim | |
| Opened reagents are stable 14 days at | ||
| 2-8°C in the original vial. |
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