HEMOSIL RECOMBIPLASTIN

K043184 · Instrumentation Laboratory CO · GJS · Dec 22, 2004 · Hematology

Device Facts

• Record ID: K043184
• Device Name: HEMOSIL RECOMBIPLASTIN
• Applicant: Instrumentation Laboratory CO
• Product Code: GJS · Hematology
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro 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

HemosIL RecombiPlasTin is a high-sensitivity thromboplastin reagent utilizing recombinant human tissue factor (RTF). Used in clinical laboratory settings on IL Coagulation and ELECTRA systems to analyze human citrated plasma samples. Reagent facilitates quantitative determination of Prothrombin Time (PT) and Fibrinogen levels. Clinicians use these outputs to evaluate the extrinsic coagulation pathway and monitor patients undergoing Oral Anticoagulant Therapy (OAT). The device provides standardized coagulation metrics, aiding in the management of anticoagulant dosing and assessment of clotting function.

Clinical Evidence

Bench testing only. Precision assessed using three levels of control plasma for PT and two levels for fibrinogen; PT CV% ranged 0.9-1.4% (within-run) and 1.3-3.9% (total). Method comparison study (n=98 citrated plasma samples) compared optimized ACL Advance performance against ACL TOP predicate; PT slope 1.039 (r=0.9985), Fibrinogen slope 0.938 (r=0.9811).

Technological Characteristics

Reagent: Recombinant human tissue factor (RTF) based thromboplastin. Application: In vitro diagnostic quantitative determination of PT and Fibrinogen. Compatibility: IL Coagulation and ELECTRA systems. Optimization: Instrument-specific parameter settings for ACL Futura and ACL Advance.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma 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

• HemosIL RecombiPlasTin (K012768)

Reference Devices

• ACL Futura (K951891)
• ACL Advance (K002400)
• ACL TOP (K033414)
• HemosIL Fibrinogen-C (K931721)

Submission Summary (Full Text)

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K043184

DEC 22 2004

## Section 3 HemosIL RecombiPlasTin 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:

November 16, 2004

### Device Name:

HemosIL RecombiPlasTin

### Classification Name:

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

### Legally Marketed Device:

K012768 HemosIL RecombiPlasTin

### Device Description:

HemosIL RecombiPlasTin is 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).

The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.

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

The performance of HemosIL RecombiPlasTin with optimized PT and fibrinogen parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially Pauinalers to the performance of the current legally marketed device on the ACL TOP (K033414).

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

#### Summary of Performance Data:

### Within Run Precision

Within run and total precision assessed over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen gave the following results:

| Prothrombin Time (PT) | Mean (Seconds) | CV% (Within run) | CV% (Total) |
|-----------------------|----------------|------------------|-------------|
| Normal Control | 11.6 | 0.9 | 1.3 |
| Low Abnormal Control | 30.3 | 1.4 | 2.3 |
| High Abnormal Control | 51.1 | 1.4 | 3.9 |

### Method Comparison

In a method comparison study evaluating 98 citrated plasma samples, the slopes and correlation coefficients (r) are shown below for the legally marketed HemosIL RecombiPlasTin on an ACL Advance with optimized PT and fibrinogen parameters versus Hemos L RecombiPlasTin for PT and HemosIL Fibrinogen-C (K931721) for fibrinogen on the ACL TOP:

| | Slope | r |
|--------------------|-------|--------|
| PT (seconds) | 1.039 | 0.9985 |
| Fibrinogen (mg/dL) | 0.938 | 0.9811 |

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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the bird symbol in a circular fashion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 2004

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

k043184 Re:

Trade/Device Name: HemosIL RecombiPlasTin- Optimized Parameter Settings on the ACL Futura/ ACL Advance

Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time set Regulatory Class: Class II Product Code: GJS Dated: December 6, 2004 Received: December 8, 2004

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 (OS) 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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Page 2

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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices 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): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL RecombiPlasTin - Optimized Parameter Settings on the ACL Futura/ACL Advance

### Indications for Use:

HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro 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).

| Prescription Use | <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
|-----------------------------|---------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(OIVD)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices

| Divis | |
|---------|---------|
| Offic | |
| Evalua. | |
| 510(k) | K043184 |