IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, 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 (turbidimetric immunoassay).

Device Description

IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF.Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, 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 (turbidimetric immunoassay).

AI/ML Overview

Acceptance Criteria and Device Performance Study for IL Test™ von Willebrand Factor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for the slope and correlation coefficient. Instead, it presents the performance of the device and claims substantial equivalence to the predicate device. For the purpose of this response, we will consider the strong correlation and near-unity slopes observed as the de facto "met" criteria for substantial equivalence in this context. Similarly, for precision, while no explicit criteria are given, the achieved %CV values are presented as satisfactory.

Metric	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (ACL Futura)	Reported Device Performance (ACL 6000)
Method Comparison
Correlation Coefficient (r)	Close to 1.0 (indicating strong agreement with predicate)	0.997	0.996
Slope	Close to 1.0 (indicating proportional agreement with predicate)	1.03	1.00
Within-Run Precision (% CV)
Normal Level	Low % CV (indicating good reproducibility)	3.51	1.41
Abnormal Level I	Low % CV (indicating good reproducibility)	2.48	1.25
Abnormal Level II	Low % CV (indicating good reproducibility)	3.16	2.18

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 120 citrated plasma samples.
Data Provenance: The document does not explicitly state the country of origin. It is a submission to the U.S. FDA, indicating the study was likely conducted to support a U.S. market application. The study type is retrospective, as it involves evaluating existing plasma samples with vWF:Ag levels ranging from 0.3% to 634.3%.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (vWF:Ag). The "ground truth" for such assays is typically established by comparative analysis against a legally marketed predicate device using clinical samples, rather than expert interpretation of images or clinical assessments by a panel of experts. Therefore, the concept of "number of experts" and "qualifications of those experts" as applied to medical imaging interpretation or clinical diagnosis does not directly apply here. The "ground truth" for the test set is derived from the measurements obtained by the predicate device (Asserachrom® vWF).

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is an IVD assay where "ground truth" is established by comparison to a predicate device, not by expert consensus or adjudication. The comparison involves quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging devices where human readers interpret cases, and the AI's effect on reader performance is evaluated. The IL Test™ von Willebrand Factor is an automated in vitro diagnostic assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The performance data presented in the summary, including method comparison and precision, represents the automated performance of the IL Test™ von Willebrand Factor device without human intervention beyond sample loading and running the assay according to manufacturer instructions. The results are generated directly by the "IL Coagulation Systems" (ACL Futura and ACL 6000) using the IL Test™ reagent.

7. The Type of Ground Truth Used

The type of ground truth used is comparison to a legally marketed predicate device. The vWF:Ag levels measured by the predicate device (Asserachrom® vWF) on the 120 plasma samples served as the reference for evaluating the performance of the IL Test™ von Willebrand Factor.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the IL Test™ von Willebrand Factor. This is typical for traditional IVD assays, which are developed through chemical and assay formulation, optimization, and validation against established methods and clinical samples, rather than through machine learning model training on large datasets in the same way an AI-driven imaging device would. The performance data presented is for validation, not training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for this type of IVD assay. The development process would have involved establishing analytical performance characteristics and clinical utility through iterative experimental work and comparison to existing methods, but not in the framework of a "training set" with expert-established ground truth in the AI sense.

Summary

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Section 3 IL Test™ von Willebrand Factor - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464

Summary Prepared:

August 11, 1999

Name of the Device:

IL Test™ von Willebrand Factor

Classification Name(s):

864.7290	Factor Deficiency Test	Class II
81GGP	Test, Qualitative and Quantitative Factor Deficient

Identification of predicate device(s):

K860371 Asserachrom® vWF

Description of the device/intended use(s):

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

IL Test™ von Willebrand Factor is substantially equivalent to the commercially available predicate device (Asserachrom® vWF) in performance and intended use.

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Section 3 IL Test™ von Willebrand Factor - 510(k) Summary (Cont.) (Summary of Safety and Effectiveness)

Summary of Performance Data:

In method comparison studies evaluating 120 citrated plasma samples with vWF:Ag levels ranging from 0.3% to 634.3% on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ von Willebrand Factor versus the predicate device are shown below:

	%vWF:Ag
IL System	Slope	r
ACL Futura	1.03	0.997
ACL 6000	1.00	0.996

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

		%vWF:Ag
ACL Futura	NormalLevel	AbnormalLevel I	AbnormalLevel II
Mean	99.50	79.45	35.54
% CV	3.51	2.48	3.16
		%vWF:Ag
	NormalLevel	AbnormalLevel I	AbnormalLevel II
ACL 6000Mean	101.52	80.83	33.67
% CV	1.41	1.25	2.18

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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 depiction of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

NOV - 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

Re: K992704 Trade Name: IL Test™ von Willebrand Fractor Regulatory Class: II Product Code: GGP Dated: August 11, 1999 Received: August 12, 1999

Dear Ms. Marble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K992704

Device Name: IL Test™ von Willebrand Factor

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pete-9. Madini

Prescription Use
(Per 21 CFR 801.019)

✓

OR Over-The-Counter Use

Section 2

IL Test™ von Willebrand Factor 510(k)

Page 1 of 1

Regulation Number and Section

§ 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).