HEMOSIL FACTOR V DEFICIENT PLASMA

K023839 · Instrumentation Laboratory CO · GJT · Jan 14, 2003 · Hematology

Device Facts

• Record ID: K023839
• Device Name: HEMOSIL FACTOR V DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Jan 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V. Used in clinical laboratories on IL Coagulation and ELECTRA systems. Principle of operation: modified prothrombin time (PT) assay. Patient plasma is diluted and mixed with factor V deficient plasma; clotting time correction is measured. Output is factor V activity percentage, interpolated from a calibration curve. Results assist clinicians in diagnosing factor V deficiencies and evaluating extrinsic pathway abnormalities. Benefits include standardized, quantitative assessment of coagulation factor activity.

Clinical Evidence

Bench testing only. Method comparison study evaluated 60 citrated plasma samples (30 normal/30 abnormal) across various IL and ELECTRA systems, yielding correlation coefficients (r) between 0.9814 and 0.9945. Precision assessed over 80 runs (n=80) across multiple instruments, with total CV% ranging from 1.7% to 7.6%.

Technological Characteristics

Human plasma immunodepleted of factor V. Reagent used with PT reagent (HemosIL RecombiPlasTin). Designed for use on automated IL Coagulation and ELECTRA systems. Quantitative assay based on prothrombin time.

Indications for Use

Indicated for the quantitative determination of factor V activity in citrated plasma for patients requiring assessment of extrinsic pathway coagulation factors.

Predicate Devices

• Hemoliance Factor V Deficient Plasma (K893533)
• IL Test Factor V Deficient Plasma (K002400)

Reference Devices

• HemosIL RecombiPlasTin (K012768)

Submission Summary (Full Text)

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K023839

JAN 1 4 2003

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

### Submitted by:

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

### Contact Person:

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

## Summary Prepared:

November 15, 2002

## Name of the Device:

HemosIL Factor V Deficient Plasma

## Classification Name(s):

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

## Identification of Predicate Device(s):

| K893533 Hemoliance Factor V Deficient Plasma on ELECTRA Series Analyzers |
|--------------------------------------------------------------------------|
| K002400 IL Test Factor V Deficient Plasma* on ACL Family of Analyzers |
| *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems |

*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 V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V 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 V. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor V in the patient plasma, interpolated from a calibration curve.

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

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

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## Section 3 HemosIL Factor V 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 V Deficient Plasma versus the predicate devices are shown below:

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

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

| IL System | Slope | r |
|-----------|--------|--------|
| E1400C | 1.0161 | 0.9877 |

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

| IL System | Slope | r |
|------------|--------|--------|
| ACL 300 | 1.0005 | 0.9932 |
| ACL 6000 | 0.9771 | 0.9940 |
| ACL 9000 | 0.9746 | 0.9945 |
| ACL Futura | 1.1331 | 0.9814 |

### 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 V | Within run<br>CV% | Total<br>CV% |
|------------------|----------------------|--------------------|-------------------|--------------|
| ACL 300 | Normal Control | 110.6 | 1.0 | 3.1 |
| | Low Abnormal Control | 30.1 | 1.8 | 3.5 |
| ACL 6000 | Normal Control | 115.1 | 1.5 | 3.0 |
| | Low Abnormal Control | 31.5 | 1.9 | 2.8 |
| ACL 9000 | Normal Control | 113.7 | 1.2 | 1.7 |
| | Low Abnormal Control | 29.0 | 4.0 | 5.6 |
| ACL Advance | Normal Control | 132.4 | 6.0 | 7.6 |
| | Low Abnormal Control | 27.1 | 4.1 | 5.7 |
| ELECTRA<br>1400C | Normal Control | 101.0 | 2.1 | 3.5 |
| | Low Abnormal Control | 24.0 | 1.5 | 2.6 |

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 1 4 2003

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

Re: k023839

> Trade/Device Name: HemosIL Factor V Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency tests Regulatory Class: II Product Code: GJT Dated: November 15, 2002 Received: November 18, 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.

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#### Page 2

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.

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). 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 vours.

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): _ 50 93839

Device Name: HemosIL Factor V Deficient Plasma

Indications for Use:

HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V 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

(División Sigh-Off)

Division of Clinical Laboratory Devices K023839

510(k) Number

Prescription Use

OR Over-The-Counter Use

The-Counter Use

HemosIL Factor V Deficient Plasma 510(k)