HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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 and to monitor Antithrombin substitution therapy. For in vitro diagnostic use.

Device Description

AI/ML Overview

The HemosIL Liquid Antithrombin XL device is a modified version of the HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes. The modification does not alter the fundamental scientific technology or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma. It is intended as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

1. Table of acceptance criteria and the reported device performance:

The provided document describes performance metrics related to precision and method comparison but does not explicitly state pre-defined acceptance criteria (e.g., "CV must be < X%" or "correlation coefficient must be > Y%"). Instead, it presents the results of these studies. For the method comparison, the results are presented in a highly obfuscated and unreadable table due to OCR errors.

However, based on standard laboratory practice for diagnostic assays, the reported precision (CV%) values demonstrate acceptable performance for an Antithrombin assay, especially given the range of AT levels tested. The predicate device (HemosIL Antithrombin K980499) serves as the benchmark for substantial equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Within-Run Precision	Low CV% to demonstrate consistency within a single run	Normal: 2.5% CV, Low Abnormal: 4.4% CV, High Abnormal: 6.4% CV
Between-Run Precision	Low CV% to demonstrate consistency across multiple runs	Normal: 3.4% CV, Low Abnormal: 4.9% CV, High Abnormal: 7.4% CV
Method Comparison	Substantial equivalence to the predicate device (K980499)	Data unreadable due to OCR errors.

2. Sample size used for the test set and the data provenance:

Precision Studies:
- For Normal, Low Abnormal, and High Abnormal control levels, the sample size (n) for each level was 60.
- Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based performance evaluations, likely retrospective as they involve control plasmas rather than patient samples for the precision part.
Method Comparison Study:
- The sample size for the method comparison study is not explicitly stated in the readable portion of the provided text. The table intended to present this data is corrupted.
- Data provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" often refers to reference methods or clinically established values for the analytes in the control or patient samples. The document focuses on comparing the new device to a predicate device and evaluating its precision, not on new clinical diagnoses established by experts.

4. Adjudication method for the test set:

This information is not applicable to this type of study for an in vitro diagnostic device where the "truth" is typically laboratory-derived values or predicate device results, not expert consensus on interpretations.

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:

This is not applicable. The HemosIL Liquid Antithrombin XL is an automated chromogenic assay, not an imaging device or AI-driven diagnostic tool that relies on human readers or interpretations. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is an automated laboratory assay, which by its nature operates in a "standalone" fashion (algorithm/reagent/instrument only) to produce a quantitative result. The performance data provided, specifically precision and method comparison, represent this standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the primary output of the assay.

7. The type of ground truth used:

Precision Studies: The "ground truth" for precision is the mean Antithrombin (% AT) value established for each control level (Normal, Low Abnormal, High Abnormal). This is typically determined through repeated measurements and confirmation with established methods.
Method Comparison Study: The "ground truth" for the modified device (HemosIL Liquid Antithrombin XL) was the results obtained from the legally marketed predicate device (HemosIL Antithrombin K980499). The study aimed to show substantial equivalence to this predicate.

8. The sample size for the training set:

For an in vitro diagnostic assay like this, there isn't typically a "training set" in the machine learning sense. The assay is based on chemical reactions and photometric detection. The development and optimization of the reagent volumes and assay parameters would involve extensive experimentation and optimization, but not a distinct "training set" of data in the way an AI algorithm is trained. The reported values for precision are from performance studies, not "training."

9. How the ground truth for the training set was established:

As indicated above, the concept of a "training set" and associated "ground truth" in the machine learning context does not directly apply to the development and validation of this chemical assay. The "ground truth" for optimizing the assay parameters would be the known concentrations of Antithrombin in reference materials and controls, used to ensure accuracy and precision.

Summary

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K033775

Section 3 HemosIL Liquid Antithrombin XL 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

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

Summary Prepared:

December 2, 2003

Name of the Device:

HemosIL Liquid Antithrombin XL

Classification Name:

864.7060	Antithrombin III Assay	Class II
81JBQ	Antithrombin III Quantitation

Identification of predicate device:

K980499 HemosIL Antithrombin

Description of the modified device:

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

The modified HemosIL Liquid Antithrombin XL is substantially equivalent in performance, intended use, safety and effectiveness to HemosIL Antithrombin (K980499).

Summary of Performance Data:

Within run and between run precision assessed over multiple runs using normal and two abnormal levels of control plasmas gave the results below:

Control Level	n	Mean% AT	Within Run%CV	Between Run%CV
Normal	60	100.85	2.5	3.4
Low Abnormal	60	32.80	4.4	4.9
High Abnormal	60	21.82	6.4	7.4

The following results were obtained in a method comparison study comparing HemosIL Liquid Antithrombin XL to the legally marketed HemosIL Antithrombin (K980499):

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around it. The eagle is facing to the left and the text is in all capital letters.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 2 2004

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

K033775 Trade/Device Name: HemosIL Liquid Antithrombin XL Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III assay Regulatory Class: Class II Product Code: JBQ Dated: December 2, 2003 Received: December 3, 2003

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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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 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 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): K033775

Device Name: HemosIL Liquid Antithrombin XL

Indications for Use:

Hemos L Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400).

This modification does not alter the fundamental scientific technology of the device or its intended use as 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 and to monitor Antithrombin substitution therapy.

For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

i. P. Erwin

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K033775

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use

Special 510(k): HemosIL Liquid Antithrombin XL

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).