HemosIL von Willebrand Factor Antigen

K223402 · Instrumentation Laboratory CO · GGP · Dec 9, 2022 · Hematology

Device Facts

• Record ID: K223402
• Device Name: HemosIL von Willebrand Factor Antigen
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Dec 9, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

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.

Device Story

HemosIL von Willebrand Factor Antigen is an in vitro diagnostic reagent used for the quantitative determination of von Willebrand Factor antigen in human plasma. The device is used in clinical laboratory settings by trained laboratory personnel. The modification involves a change to the open vial stability claim, reducing it from 3 months to 14 days, validated according to CLSI EP25-A guidelines. The fundamental scientific technology remains unchanged from the previously cleared device.

Clinical Evidence

Bench testing only. The modification to the open vial stability claim was validated in accordance with CLSI EP25-A guidelines. Testing verified that all acceptance criteria were met for the 14-day stability period.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents consist of polystyrene latex particles coated with rabbit polyclonal anti-VWF antibodies, HEPES buffer, bovine serum albumin, stabilizers, and preservatives. Operates on IL Coagulation Systems (ACL Elite, ACL TOP families).

Indications for Use

Indicated for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma using automated IL Coagulation Systems.

Predicate Devices

• HemosIL von Willebrand Factor Antigen (K223402)

Submission Summary (Full Text)

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# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K223402

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. (For a preamendments device, a statement to this effect has been provided.)
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 (labeling changes are permitted as long as they do not affect the intended use).
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. This change was to modify the open vial stability labeled claim

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.govK223402 - Page 1 of 2

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for HemosIL von Willebrand Factor Antigen from 3 months to 14 days based on testing to the current CLSI EP25-A guideline.

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.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.govK223402 - Page 2 of 2