IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.

Device Description

This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IL Test™ Liquid Antithrombin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (IL Test™ Antithrombin). The key performance metrics are method comparison (correlation with the predicate) and within-run precision.

Metric	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (ACL 6000)	Reported Device Performance (ACL Futura)
Method Comparison
Slope (vs. Predicate)	Close to 1.00	0.99	1.01
Correlation Coefficient (r)	Close to 1.00 (e.g., >0.95 or >0.98)	0.995	0.994
Within Run Precision
Normal Plasma % CV	Low (typically <5-10% depending on assay)	2.54	2.10
Abnormal Plasma I % CV	Low (typically <5-10% depending on assay)	3.27	2.47
Abnormal Plasma II % CV	Low (typically <15% for very low levels)	7.54	12.10

Interpretation of Acceptance: The reported performance metrics (slopes close to 1, correlation coefficients very close to 1, and low %CVs) strongly indicate that the device meets the implied acceptance criteria for substantial equivalence to the predicate device.

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

Sample Size: 118 citrated plasma samples.
- 40 normal samples
- 78 abnormal samples
Data Provenance: The document does not explicitly state the country of origin. It is a prospective study in the sense that these samples were tested specifically for the purpose of this comparison. However, whether the samples themselves were collected prospectively or retrospectively from a biobank is not specified.

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

This type of in vitro diagnostic device (IVD) study does not typically involve human expert interpretation of images or other subjective data for ground truth establishment. For method comparison studies in IVDs, the "ground truth" (or reference standard) is the result obtained from the predicate device. Therefore, the concept of "experts" in the context of establishing ground truth as you'd find in an AI imaging study is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the ground truth is the predicate device's result. There is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic device, not an AI imaging or diagnostic algorithm designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is effectively a standalone performance study. The IL Test™ Liquid Antithrombin system (analyzer + reagents) is compared directly to the predicate device, operating without human interpretation influencing the numerical result.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the predicate device's performance. The new device's results were compared to those obtained using the established K980499 IL Test™ Antithrombin.

8. The Sample Size for the Training Set

There is no mention of a training set in the context of machine learning or AI. This device is a diagnostic assay (reagents and an automated system) based on a chemical reaction, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of IVD device.

Summary

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994238

Section 3 IL Test™ Liquid Antithrombin - 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:

December 15, 1999 (Revised April 11, 2000)

Name of the Device:

IL Test™ Liquid Antithrombin

Classification Name(s):

864.7060	Antithrombin III Assay	Class II
81JBQ	Antithrombin III Quantitation

Identification of Predicate Device(s):

K980499 IL Test™ Antithrombin

Description of the Device/Intended use(s):

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

IL Test™ Liquid Antithrombin uses the same test principle as the predicate device (IL Test™ Antithrombin) and is substantially equivalent in performance, intended use and safety and effectiveness.

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Section 3 IL Test™ Liquid Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating 118 citrated plasma samples (40 normals and 78 abnormals) on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ Liquid Antithrombin versus the predicate device are shown below:

New Device vs. Predicate Device
IL System	Slope	r
ACL 6000	0.99	0.995
ACL Futura	1.01	0.994

Within Run Precision

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

		Normal	Abnormal	Abnormal
ACL 6000	Level	Level	Level I	Level II
Mean (% Activity)		102.6	53.6	22.1
% CV		2.54	3.27	7.54
ACL Futura	Level	Level	Level I	Level II
Mean (% Activity)		104.6	54.2	25.2
% CV		2.10	2.47	12.10

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract caduceus, a symbol often associated with healthcare, featuring three wavy lines.

JUN 2 3 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K994238

Trade Name: IL Test™ Liquid Antithrombin Regulatory Class: II Product Code: JBQ Dated: April 11, 2000 Received: April 12, 2000

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

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to obegin mantening , puivalence of your device to a legally marketed noutleation. The FDF Intentig of castion 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 II you desire specific advices), please contact devices), please contact the Office of Compliance at additionally 007.10 for mintes are questions on the promotion and advertising of your device, (301) 594-4566. Truditionally, for quest at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsionnes and institute and more (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): 994238

Device Name: IL Test™ Liquid Antithrombin

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign (Off)
Division of Clinical Laboratory Devices
510(k) Number	K994238

Prescription Use (Per 21 CFR 801.019)		OR	Over-The-Counter Use
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Section 2 IL Test™ Liquid Antithrombin 510(k) Page 1 of 1

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).