HEMOSIL FACTOR VII DEFICIENT PLASMA

K024082 · Instrumentation Laboratory CO · GJT · Feb 12, 2003 · Hematology

Device Facts

• Record ID: K024082
• Device Name: HEMOSIL FACTOR VII DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Device Story

HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII; used as a reagent in clinical laboratories for quantitative determination of Factor VII activity. The device is used in conjunction with a prothrombin time (PT) assay on IL Coagulation and ELECTRA systems. Patient plasma is diluted and mixed with the Factor VII deficient plasma; the degree of clotting time correction is proportional to the Factor VII concentration in the patient sample. Results are interpolated from a calibration curve to determine % activity. This quantitative measurement assists clinicians in diagnosing and monitoring extrinsic pathway coagulation factor abnormalities. The device is intended for professional in vitro diagnostic use.

Clinical Evidence

Bench testing only. Method comparison study performed on 60 citrated plasma samples (30 normal, 30 abnormal) across multiple IL and ELECTRA systems. Correlation coefficients (r) ranged from 0.9943 to 0.9996; slopes ranged from 0.9646 to 1.0045. Precision assessed over 80 runs; within-run CV% ranged from 0.8% to 4.7%, and total CV% ranged from 1.9% to 5.9%.

Technological Characteristics

Human plasma immunodepleted of Factor VII. Reagent for PT-based coagulation assays. Designed for use on automated IL Coagulation and ELECTRA systems. No specific materials of construction or energy sources defined as the device is a biological reagent.

Indications for Use

Indicated for the quantitative determination of Factor VII activity in citrated plasma for patients requiring assessment of extrinsic pathway coagulation factors. Used in clinical laboratory settings on IL Coagulation and ELECTRA systems.

Predicate Devices

• Hemoliance Factor VII Deficient Plasma on ELECTRA Series Analyzers (K893535)
• IL Test Factor VII Deficient Plasma on ACL Family of Analyzers (K002400)

Reference Devices

• HemosIL RecombiPlasTin (K012768)

Submission Summary (Full Text)

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K024082

## Section 3 HemosIL Factor VII Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)

### Submitted by:

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

FEB 1 2 2003

### Contact Person:

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

### Summary Prepared:

December 10, 2002

#### Name of the Device:

HemosIL Factor VII Deficient Plasma

### Classification Name(s):

| 864.7290 | Factor Deficiency Tests | Class II |
|----------|--------------------------------------|----------|
| 81GJT | Plasma, Coagulation Factor Deficient | |

### Identification of Predicate Device(s):

Hemoliance Factor VII Deficient Plasma on ELECTRA Series Analyzers K893535 IL Test Factor VII Deficient Plasma* on ACL Family of Analyzers K002400 *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems, most recently the ACL Advance.

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

HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.

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

HemosIL Factor VII Deficient Plasma is substantially equivalent to Hemoliance Factor VII Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor VII Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.

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# Section 3 HemosIL Factor VII Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)

### Summary of Performance Data:

### Method Comparison

In method comparison studies evaluating 60 citrated plasma samples (30 normal/ 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VII Deficient Plasma versus the predicate devices are shown below:

NOTE: HemosIL RecombiPlasTin (K012768) was used as the PT reagent in all testing.

## HemosIL Factor VII Deficient Plasma vs. Predicate Hemoliance Factor VII Deficient Plasma on ELECTRA

| IL System | Slope | r |
|-----------|--------|--------|
| E1400C | 0.9683 | 0.9967 |

## HemosIL Factor VII Deficient Plasma vs. Predicate IL Test Factor VII Deficient Plasma on ACL Family

| IL System | Slope | r |
|------------|--------|--------|
| ACL 300 | 1.0045 | 0.9994 |
| ACL 6000 | 0.9646 | 0.9989 |
| ACL 9000 | 0.9778 | 0.9996 |
| ACL Futura | 0.9678 | 0.9943 |

## Within Run Precision

Within run and total precision assessed over multiple runs (n=80) using two levels of control gave the following results:

| Instrument | Control | Mean<br>% Factor VII | Within run<br>CV% | Total<br>CV% |
|------------------|----------------------|----------------------|-------------------|--------------|
| ACL 300 | Normal Control | 99.6 | 1.0 | 2.9 |
| | Low Abnormal Control | 49.1 | 1.2 | 2.7 |
| ACL 6000 | Normal Control | 100.5 | 1.4 | 1.9 |
| | Low Abnormal Control | 49.9 | 1.5 | 2.5 |
| ACL 9000 | Normal Control | 99.4 | 0.8 | 2.7 |
| | Low Abnormal Control | 47.6 | 1.4 | 3.6 |
| ACL Advance | Normal Control | 99.9 | 4.7 | 5.7 |
| | Low Abnormal Control | 50.9 | 4.6 | 5.9 |
| ELECTRA<br>1400C | Normal Control | 79.4 | 2.2 | 2.7 |
| | Low Abnormal Control | 37.8 | 2.4 | 3.4 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines suggesting movement or connection. The overall design is simple and conveys a sense of unity and service.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

FEB 1 2 2003

Re: k024082 Trade/Device Name: HemosIL Factor VII Deficient Plasma Regulation Number: 21 CFR § 864,7290 Regulation Name: Plasma, Coagulation Factor Deficient Regulatory Class: II Product Code: GJT Dated: December 10, 2002 Received: December 11, 2002

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/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): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL Factor VII Deficient Plasma

Indications for Use:

Hemos L Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K024082
510(k) Number

Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

HemosIL Factor VII Deficient Plasma 510(k)