IL TEST PT-FIBRINOGEN RECOMBINANT

K981479 · Instrumentation Laboratory CO · GJS · Jul 7, 1998 · Hematology

Device Facts

• Record ID: K981479
• Device Name: IL TEST PT-FIBRINOGEN RECOMBINANT
• Applicant: Instrumentation Laboratory CO
• Product Code: GJS · Hematology
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

Device Story

IL Test™ PT-Fibrinogen Recombinant is an in vitro diagnostic reagent used for coagulation testing. It utilizes high-sensitivity recombinant rabbit tissue factor-based thromboplastin to analyze human citrated plasma samples. The device is designed for use on automated laboratory systems (e.g., ACL 3000, ACL Futura) to measure Prothrombin Time (PT) and quantify fibrinogen levels. Operated by laboratory technicians in clinical settings, the device provides quantitative results that assist healthcare providers in evaluating the extrinsic coagulation pathway and monitoring patients undergoing Oral Anticoagulant Therapy (OAT). By providing accurate coagulation metrics, the device aids in clinical decision-making regarding patient anticoagulation management.

Clinical Evidence

Bench testing only. Method comparison studies (n=79) evaluated normal and abnormal plasma samples on ACL 3000 and ACL Futura systems. Results showed strong correlation (r=0.918–0.982) and slopes (0.93–1.09) compared to the predicate. Precision studies (within-run) reported %CVs ranging from 0.53% to 1.99% for PT and 2.90% to 5.03% for Fibrinogen.

Technological Characteristics

Reagent-based diagnostic system using recombinant rabbit tissue factor-based thromboplastin. Designed for use on automated coagulation analyzers (ACL 3000, ACL Futura). Measures PT and fibrinogen via coagulation pathway activation in citrated plasma.

Indications for Use

Indicated for in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma. Used for evaluation of extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT), and quantitation of fibrinogen.

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

• IL Test™ PT-Fibrinogen HS Plus (K933252/S)

Submission Summary (Full Text)

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## JUL - 7 1998

## Section 3

## IL Test™ PT-Fibrinogen Recombinant - 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

### Contact Person:

Carol Marble Phone: [phone]

### Summary Prepared:

April 23, 1998

#### Name of the Device:

IL Test™ PT-Fibrinogen Recombinant

### Classification Name(s):

| 864.7340 | Fibrinogen determination system | Class II |
|----------|---------------------------------|----------|
| 864.7750 | Prothrombin time test | Class II |
| 81GIS | Test, fibrinogen | |
| 81GIS | Test, time, prothrombin | |

#### Identification of Predicate Device(s):

IL Test™ PT-Fibrinogen HS Plus K933252/S

### Description of the Device/Intended use(s):

IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:

IL Test™ PT-Fibrinogen Recombinant has the same test principle as the predicate IL Test™ PT-Fibrinogen HS Plus and is substantially equivalent in performance, intended use and safety and effectiveness.

IL Test™ PT-Fibrinogen Recombinant 510(k)

169814799

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## Section 3 IL Test™ PT-Fibrinogen Recombinant - 510(k) Summary (Summary of Safety and Effectiveness)

## Summary of Performance Data:

In method comparison studies evaluating normal and abnormal plasma samples (n=79) on an ACL 3000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ PT-Fibrinogen Recombinant versus the predicate device are shown below:

| System | PT (seconds) | | Fibrinogen (mg/dL) | |
|------------|--------------|-------|--------------------|-------|
| | Slope | r | Slope | r |
| ACL 3000 | 1.04 | 0.918 | 0.93 | 0.977 |
| ACL Futura | 1.09 | 0.949 | 1.05 | 0.982 |

Within run precision assessed over multiple runs using both normal and abnormal samples gave the following results:

| | | PT (seconds) | Fibrinogen (mg/dL) | | | | |
|------------|------|--------------|--------------------|----------|--------------------|--------|----------|
| ACL 3000 | | Normal | Abnormal | Normal | Abnormal | | |
| | Mean | 10.97 | 24.52 | 216.04 | 116.30 | | |
| | % CV | 0.53 | 1.20 | 4.25 | 4.36 | | |
| ACL Futura | | PT (seconds) | Normal | Abnormal | Fibrinogen (mg/dL) | Normal | Abnormal |
| | | Normal | Abnormal | Normal | Abnormal | | |
| | Mean | 11.98 | 27.69 | 261.55 | 106.11 | | |
| | % CV | 1.37 | 1.99 | 5.03 | 2.90 | | |

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 1998 JUL

Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

Re: K981479 IL Test PT-Fibrinogen Recombinant Regulatory Class: II Product Code: GJS, GIS Dated: April 23, 1998 Received: April 24, 1998

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ದಿ 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "[e-mail]".

Sincerely yours,

Steven Autman

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

## 81479 510(k) Number (if known):

Device Name: IL Test™ PT-Fibrinogen Recombinant

## Indications for Use:

IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity 事 recombinant rabbit tissue factor based thromboplastin.

This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

## (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 _4981479

Prescription Use
(Per 21 CFR 801.019)

:

OR Over-The-Counter Use _

IL Test™ PT-Fibrinogen Recombinant 510(k)