HemosIL von Willebrand Factor Antigen

K200033 · Instrumentation Laboratory CO · GGP · Aug 19, 2020 · Hematology

Device Facts

• Record ID: K200033
• Device Name: HemosIL von Willebrand Factor Antigen
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Aug 19, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

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.

Device Story

The HemosIL von Willebrand Factor Antigen is an in vitro diagnostic assay used on IL Coagulation Systems to quantify VWF:Ag in human citrated plasma. The device utilizes a latex particle-enhanced immunoturbidimetric principle; plasma samples are mixed with a latex reagent containing rabbit polyclonal antibodies against VWF and a reaction buffer. VWF:Ag in the sample causes agglutination of the coated latex particles. The system measures the resulting decrease in transmitted light, which is directly proportional to the VWF:Ag concentration. The assay is performed in a clinical laboratory setting by trained personnel. Results are used by clinicians to assess VWF levels, aiding in the diagnosis or management of related coagulation disorders. This submission modifies the Rheumatoid Factor interference claim in the product labeling to 50 IU/mL for all specified IL Coagulation Systems.

Clinical Evidence

No clinical data provided. The submission relies on a literature-supported modification to the Rheumatoid Factor interference claim. Bench testing was not required for this change.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents include polystyrene latex particles coated with rabbit polyclonal anti-VWF antibodies, bovine serum albumin, buffers, stabilizers, and preservatives. Operates on IL Coagulation Systems (ACL Family, ACL TOP Family, ACL TOP Family 50 Series).

Indications for Use

Indicated for the quantitative determination of von Willebrand Factor antigen (vWF:Ag) in human citrated plasma on ACL Family Systems, ACL TOP Family, and ACL TOP Family 50 Series analyzers.

Predicate Devices

• HemosIL von Willebrand Factor Antigen (K992704)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K200033

B Applicant

Instrumentation Laboratory Co.

C Proprietary and Established Names

HemosIL von Willebrand Factor Antigen

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GGP | Class II | 21 CFR 864.7290 - Factor Deficiency Test | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II, device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (HemosIL von Willebrand Factor Antigen, K992704).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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The change was for a modified Rheumatoid Factor (RF) interference claim in the "Limitations/Interfering substances" section of the HemosIL von Willebrand Factor Antigen package insert from "the presence of Rheumatoid Factor may produce an overestimation of vWF:Ag results on ACL Family Systems" and "vWF:Ag results on ACL TOP Family and ACL TOP Family 50 Series are not affected by Rheumatoid Factor up to 750 IU/mL" to a new claim. The new claim states "vWF:Ag results on ACL Family Systems are not affected by Rheumatoid Factor up to 50 IU/mL" and "vWF:Ag results on ACL TOP Family and ACL TOP Family 50 Series are not affected by Rheumatoid Factor up to 50 IU/mL."

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

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