HEMOSIL RECOMBI PLASTIN

K012768 · Instrumentation Laboratory CO · GJS · Sep 18, 2001 · Hematology

Device Facts

• Record ID: K012768
• Device Name: HEMOSIL RECOMBI PLASTIN
• Applicant: Instrumentation Laboratory CO
• Product Code: GJS · Hematology
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of: - Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems - Fibrinogen on IL Coagulation Systems only The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Device Story

Reagent based on recombinant human tissue factor (RTF); used for in vitro diagnostic quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma. Operates on IL Coagulation and ELECTRA systems; evaluates extrinsic coagulation pathway; monitors Oral Anticoagulant Therapy (OAT). Clinical laboratory setting; operated by trained laboratory personnel. Output consists of PT (seconds) and Fibrinogen (mg/dL) values; used by clinicians to assess coagulation status and adjust anticoagulant therapy.

Clinical Evidence

Bench testing only. Method comparison studies performed on 180 citrated plasma samples (100 normal, 80 abnormal) across ACL 3000, ACL Futura, and ELECTRA 1400C systems. PT correlation coefficients (r) ranged 0.993-0.996; Fibrinogen correlation coefficients (r) ranged 0.933-0.957. Within-run precision assessed across three levels for PT and two levels for Fibrinogen; PT %CV ranged 0.8-2.5%; Fibrinogen %CV ranged 3.6-9.8%.

Technological Characteristics

High sensitivity thromboplastin reagent; recombinant human tissue factor (RTF) base. Designed for use on IL Coagulation and ELECTRA automated systems. Quantitative diagnostic assay for PT and Fibrinogen.

Indications for Use

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

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

• Hemoliance® RecombiPlasTin (K925604)
• IL Test™ PT-Fibrinogen (K862301)

Submission Summary (Full Text)

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# Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax: [phone]

#### Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: [phone] / Fax: [phone]

#### Summary Prepared:

August 16, 2001

#### Name of the Device:

HemosIL RecombiPlasTin

#### Classification Name(s):

| 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):

K925604 Hemoliance® RecombiPlasTin (PT Claims for IL Coagulation and ELECTRA Systems) K862301 IL Test™ PT-Fibrinogen (Fibrinogen Claims for IL Coagulation Systems Only)

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

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative determination in human citrated plasma of:

- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems

- Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

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

HemosIL RecombiPlasTin is substantially equivalent to Hemoliance® RecombiPlasTin (for Prothrombin Time on IL Coagulation and ELECTRA Systems) and IL Test™ PT-Fibrinogen (for Fibrinogen on IL Coagulation Systems only) in performance, intended use and safety and effectiveness.

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# Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)

## Summary of Performance Data:

#### Method Comparison

In method comparison studies evaluating 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples) on an ACL 3000, ACL Futura and ELECTRA 1400C, the slopes and correlation coefficients (r) for HemosIL RecombiPlasTin versus the predicate devices are shown below:

# Prothrombin Time (seconds) on IL Coagulation and ELECTRA Systems:

## New Device vs. Predicate Device for PT: Hemoliance® RecombiPlasTin

| IL System | Slope | r |
|------------|-------|-------|
| ACL 9000 | 0.90 | 0.993 |
| ACL Futura | 0.99 | 0.995 |
| E1400C | 0.95 | 0.996 |

## Fibrinogen (mg/dL) on IL Coagulation Systems Only:

# New Device vs. Predicate Device for Fib: IL Test™ PT-Fibrinogen*

| IL System | Slope | r |
|------------|-------|-------|
| ACL 9000 | 1.00 | 0.933 |
| ACL Futura | 1.10 | 0.957 |

*NOTE: Values outside the linearity claim of 700 mg/dL were removed from calculations for a respective n=164 on the ACL 9000 and n=170 on the ACL Futura.

#### Within Run Precision

Within run precision assessed over multiple runs using three levels for Prothrombin Time and two levels for Fibrinogen of control plasmas gave the following results:

| | PT (seconds) | | | Fibrinogen (mg/dL) | |
|------------|--------------|----------|-----------|--------------------|----------------|
| ACL 9000 | Level 1 | Level II | Level III | Level 1 | Low Fibrinogen |
| Mean | 11.8 | 28.8 | 57.1 | 303 | 127 |
| % CV | 0.8 | 2.5 | 1.7 | 4.3 | 3.6 |
| ACL Futura | Level 1 | Level II | Level III | Level 1 | Low Fibrinogen |
| Mean | 11.0 | 30.4 | 61.6 | 261 | 119 |
| % CV | 1.1 | 1.2 | 1.1 | 4.5 | 9.8 |
| E1400C | Level 1 | Level II | Level III | | |
| Mean | 12.3 | 29.0 | 57.8 | | |
| % CV | 0.9 | 1.9 | 2.1 | | |

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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 stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, curved design. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

SEP 1 8 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K012768 Re:

Trade Name: HemosIL RecombiPlasTin Regulation Number: 21 CFR § 864.7750 and 21 CFR § 864.7340 Regulatory Class: II Product Code: GJS, GGP, GIS Dated: August 16, 2001 Received: August 17, 2001

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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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

510(k) Number (if known): K012768

Device Name: HemosIL RecombiPlasTin

#### Indications for Use:

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:

- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems

- Fibrinogen on IL Coagulation Systems only

The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

aboratory Devices

**510(k) Number** K012768

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use

Section 2

HemosIL RecombiPlasTin 510(k)