K Number
K040843
Device Name
HEMOSIL VON WILLEBRAND ACTIVITY
Date Cleared
2004-04-30

(29 days)

Product Code
Regulation Number
864.7290
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HemosIL von Willebrand Factor Activity is an automated latex enhanced immunoassay intended for the in vitro diagnostic quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems.
Device Description
The VWF Activity kit is a latex particle enhanced immunoturbidimetric assay to quantify VWF Activity in plasma. The activity of VWF is determined by measuring the increase of turbidity produced by the agglutination of the latex reagent. A specific anti-VWF monoclonal antibody adsorbed onto the latex reagent, directed against the platelet binding site of VWF (Glycoprotein Ib receptor), reacts with the VWF of patient plasma. The degree of agglutination is directly proportional to the activity of VWF in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
More Information

K000398 Shield Von Willebrand Factor Activity ELISA

Not Found

No
The device description details a standard immunoturbidimetric assay based on measuring light transmission changes due to agglutination. There is no mention of AI or ML in the description, performance studies, or key metrics. The analysis focuses on traditional statistical measures like correlation and precision.

No
This device is an in vitro diagnostic (IVD) immunoassay designed for quantitative determination of von Willebrand Factor Activity in human citrated plasma, which is used for diagnostic purposes and not for treating or preventing diseases.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma."

No

The device description clearly outlines a physical kit containing reagents (latex particles, monoclonal antibody) used in an immunoturbidimetric assay. This involves physical components and chemical reactions, not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma". The term "in vitro diagnostic" is clearly used.
  • Device Description: The description details a test performed on a biological sample (human citrated plasma) outside of the body ("in vitro").
  • Purpose: The purpose is to quantify a specific analyte (VWF Activity) in the plasma, which is a diagnostic measurement used to assess a patient's condition.

N/A

Intended Use / Indications for Use

HemosIL von Willebrand Factor Activity is an in vitro diagnostic automated latex enhanced immunoassay intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems by immunoturbidity.

Product codes (comma separated list FDA assigned to the subject device)

GGP

Device Description

HemosIL von Willebrand Factor Activity is an automated latex enhanced immunoassay intended for the in vitro diagnostic quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems.

The VWF Activity kit is a latex particle enhanced immunoturbidimetric assay to quantify VWF Activity in plasma. The activity of VWF is determined by measuring the increase of turbidity produced by the agglutination of the latex reagent. A specific anti-VWF monoclonal antibody adsorbed onto the latex reagent, directed against the platelet binding site of VWF (Glycoprotein Ib receptor), reacts with the VWF of patient plasma. The degree of agglutination is directly proportional to the activity of VWF 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

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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)

Method Comparison
In separate method comparison studies on an ACL 9000 (n=108) using citrated plasma samples ranging from 0 to 192% VWF activity, the correlation statistics for HemosIL von Willebrand Factor Activity versus the predicate device are shown below:
IL System: ACL 9000, % VWF Activity Slope: 0.832, Intercept: 4.782, r: 0.972

Precision
Within run and total precision assessed over multiple runs using both three levels of control plasma gave the following results:
ACL 9000: Normal Control, Mean (% VWF Activity): 79.6, CV% (Within run): 2.7, CV% (Total): 4.9
ACL 9000: Special Test Controls Level 1, Mean (% VWF Activity): 49.8, CV% (Within run): 4.6, CV% (Total): 9.0
ACL 9000: Special Test Controls Level 2, Mean (% VWF Activity): 27.7, CV% (Within run): 7.5, CV% (Total): 8.7

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K000398 Shield Von Willebrand Factor Activity ELISA

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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APR 30 2004

K040843

Section 3 HemosIL von Willebrand Factor Activity 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

March 31, 2004

Name of the Device:

HemosIL von Willebrand Factor Activity

Regulatory Information:

Regulation Section:Factor Deficiency Test (864.7290)
Classification:Class II
Product Code:GGP
Panel:Hematology

Identification of predicate device(s):

K000398 Shield Von Willebrand Factor Activity ELISA

Description of the device/intended use(s):

HemosIL von Willebrand Factor Activity is an automated latex enhanced immunoassay intended for the in vitro diagnostic quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems.

The VWF Activity kit is a latex particle enhanced immunoturbidimetric assay to quantify VWF Activity in plasma. The activity of VWF is determined by measuring the increase of turbidity produced by the agglutination of the latex reagent. A specific anti-VWF monoclonal antibody adsorbed onto the latex reagent, directed against the platelet binding site of VWF (Glycoprotein Ib receptor), reacts with the VWF of patient plasma. The degree of agglutination is directly proportional to the activity of VWF in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL von Willebrand Factor Activity is substantially equivalent to the commercially available predicate device (Shield Von Willebrand Factor Activity ELISA) in performance and intended use.

1

Section 3 (Cont.) HemosIL von Willebrand Factor Activity 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In separate method comparison studies on an ACL 9000 (n=108) using citrated plasma samples ranging from 0 to 192% VWF activity, the correlation statistics for HemosIL von Willebrand Factor Activity versus the predicate device are shown below:

| IL System | % VWF Activity
Slope | Intercept | r |
|-----------|-------------------------|-----------|-------|
| ACL 9000 | 0.832 | 4.782 | 0.972 |

Precision

Within run and total precision assessed over multiple runs using both three levels of control plasma gave the following results:

ACL 9000:Mean (% VWF Activity)CV% (Within run)CV% (Total)
Normal Control79.62.74.9
Special Test Controls Level 149.84.69.0
Special Test Controls Level 227.77.58.7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 3 0 2004

Ms. Carol Marble Director, Regulatory Affairs Instrumentation Labortory Co. 113 Hartwell Avenue Lexington, MA 02421

Re: K040843

Trade/Device Name: HemosIL von Willebrand Factor Activity Regulation Name: Factor deficiency test Regulation Number: 21 CFR 864.7290 Regulatory Class: Class II Product Code: GGP Dated: March 31, 2004 Received: April 1, 2004

Dear Ms. Marble:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Arblett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL von Willebrand Factor Activity

Indications for Use:

HemosIL von Willebrand Factor Activity is an in vitro diagnostic automated latex enhanced immunoassay intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems by immunoturbidity.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k)K040843
Prescription Use (Per 21 CFR 801.019)OR Over-The-Counter Use