HEMOSIL PT-FIBRINOGEN HS PLUS

K060931 · Instrumentation Laboratory CO · GJS · May 2, 2006 · Hematology

Device Facts

• Record ID: K060931
• Device Name: HEMOSIL PT-FIBRINOGEN HS PLUS
• Applicant: Instrumentation Laboratory CO
• Product Code: GJS · Hematology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems. For in vitro diagnostic use.

Device Story

HemosIL PT-Fibrinogen HS PLUS; high sensitivity calcium thromboplastin reagent; used for simultaneous Prothrombin Time (PT) and Fibrinogen (Fib) determination; input: human citrated plasma; operation: reagent added to plasma on IL Coagulation Systems (ACL Futura/ACL Advance); output: coagulation test results; clinical use: extrinsic pathway evaluation and oral anticoagulant therapy monitoring; modification: updated package insert with new expected values data for ACL Futura/ACL Advance systems; no changes to reagent formulation, test principle, or analytical functionality.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm that the updated expected values for the ACL Futura and ACL Advance systems met predetermined acceptance criteria.

Technological Characteristics

High sensitivity calcium thromboplastin reagent; liquid-based assay; intended for use on IL Coagulation Systems (ACL Futura/ACL Advance); no changes to reagent formulation or fundamental scientific technology.

Indications for Use

Indicated for the evaluation of the extrinsic coagulation pathway and monitoring of oral anticoagulant therapy in human citrated plasma. For prescription, in vitro diagnostic use.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• HemosIL PT-Fibrinogen HS PLUS (K933252)

Submission Summary (Full Text)

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K060931

## Section 3 HemosIL PT-Fibrinogen HS PLUS 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

MAY 2 2005

## Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 781-861-4207 Fax No.:

### Summary Prepared:

April 4, 2006

### Name of the Device:

HemosIL PT-Fibrinogen HS PLUS

### Regulatory Information:

| 864.7750 | Prothrombin Time Test | Class II |
|----------|---------------------------------|----------|
| 81GJS | Test, Time, Prothrombin | |
| 864.7340 | Fibrinogen Determination System | Class II |
| 81GIS | Test, Fibrinogen | |

## Identification of Predicate Device(s):

K933252 HemosIL PT-Fibrinogen HS PLUS

## Device Description:

HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.

### Reason for Submission:

The expected value ranges for PT and Fibrinogen on the ACL Futura/ACL Advance provided in the product insert for HemosIL PT-Fibrinogen HS PLUS are being updated based on data from a new normal range study.

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

The performance of HemosIL PT-Fibrinogen HS PLUS with the new expected value ranges for the ACL Futura and ACL Advance is not materially different from the FDA cleared device.

### Summary of New Expected Values Data:

| Assay | System | N | Range (units) |
|------------|------------------------|-----|-----------------------|
| PT | ACL Futura/ACL Advance | 119 | 11.1 - 14.5 (seconds) |
| Fibrinogen | ACL Futura/ACL Advance | 119 | 262 - 433 (mg/dL) |

These results were obtained using a specific lot of reagent. Due to the many variables which may affect clotting times, each laboratory should establish its own reference range.

| Section 3 | Special 510(k): HemosIL PT-Fibrinogen HS PLUS | Page 1 of 1 |
|-----------|-----------------------------------------------|-------------|
|-----------|-----------------------------------------------|-------------|

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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 tail feathers. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

2 3005

Re: k060931

Trade/Device Name: HemosIL PT-Fibrinogen HS PLUS Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin time test Regulatory Class: II Product Code: GJS, GIS Dated: April 4, 2006 Received: April 5, 2006

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). 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.

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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 [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/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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): K060931

Device Name: HemosIL PT-Fibrinogen HS PLUS

## Indications for Use:

HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.

For in vitro diagnostic use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista
Division Step-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Section 2

Special 510(k): HemosIL PT-Fibrinogen HS PLUS

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