HEMOSIL LIQUID ANTITHROMBIN XL

K033775 · Instrumentation Laboratory CO · JBQ · Jan 2, 2004 · Hematology

Device Facts

• Record ID: K033775
• Device Name: HEMOSIL LIQUID ANTITHROMBIN XL
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Jan 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended 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.

Device Story

HemosIL Liquid Antithrombin XL is an automated chromogenic assay for quantitative Antithrombin determination in human citrated plasma. Used on IL Coagulation Systems (e.g., ACL Futura, ACL Advance) in clinical laboratory settings. Device utilizes optimized reagent volumes to measure Antithrombin levels; results assist clinicians in diagnosing hereditary/acquired Antithrombin deficiency and monitoring substitution therapy. Operates via automated analysis of plasma samples; provides quantitative output for healthcare provider review.

Clinical Evidence

Bench testing only. Precision assessed via within-run and between-run studies using normal and two abnormal control levels (n=60 per level). Within-run %CV ranged from 2.5% to 6.4%; between-run %CV ranged from 3.4% to 7.4%. Method comparison performed against predicate device.

Technological Characteristics

Reagent-based diagnostic device. Modifications focused on reagent stability and volume. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for the quantitative determination of Antithrombin in human citrated plasma to aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

Regulatory Classification

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).

Submission Summary (Full Text)

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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: [phone] / Fax: [phone]

#### 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:

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.

#### 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<br>% AT | Within Run<br>%CV | Between Run<br>%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 [phone]. 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 [phone] or [phone] 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