HEMOSIL FACTOR X DEFICIENT PLASMA

K031122 · Instrumentation Laboratory CO · GJT · May 19, 2003 · Hematology

Device Facts

• Record ID: K031122
• Device Name: HEMOSIL FACTOR X DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: May 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X; used for in vitro diagnostic quantitative determination of Factor X activity in citrated patient plasma. Device operates on IL Coagulation and ELECTRA systems using a modified prothrombin time (PT) assay. Patient plasma is diluted and mixed with Factor X deficient plasma; clotting time correction is measured. Resulting clotting time is proportional to Factor X concentration, determined via interpolation from a calibration curve. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing Factor X deficiencies and evaluating extrinsic pathway abnormalities.

Clinical Evidence

Bench testing only. Method comparison studies performed on citrated plasma samples (n=62-63 per system) comparing subject device to predicates on ELECTRA 1600C, ACL 3000, and ACL Futura systems. Results showed strong correlation (r=0.9840 to 0.9948) and slopes ranging from 0.9461 to 1.0680. Precision studies (n=80) across five instrument models (ACL 300, 6000, 9000, Futura, ELECTRA 1400C) demonstrated within-run CVs of 0.9%–4.2% and total CVs of 2.1%–6.1% for normal and low abnormal controls.

Technological Characteristics

Human plasma immunodepleted of Factor X. Principle of operation: modified prothrombin time (PT) assay. Form factor: liquid reagent for use on automated coagulation analyzers. Connectivity: integrated with IL Coagulation and ELECTRA systems. No specific material standards or software algorithm class provided.

Indications for Use

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

Predicate Devices

• Hemoliance Factor X Deficient Plasma on ELECTRA Series Analyzers (K893523)
• IL Test Factor X Deficient Plasma on ACL Family of Analyzers (K002400)

Reference Devices

• RecombiPlasTin (K012768)
• PT-Fibrinogen Recombinant (K981479)

Submission Summary (Full Text)

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K031122

## Section 3 HemosIL Factor X Deficient Plasma - 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 Director Phone: [phone] / Fax: [phone]

Summary Prepared:

April 7, 2003

### Name of the Device:

HemosIL Factor X Deficient Plasma

### Classification Name(s):

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

### Identification of Predicate Device(s):

| K893523 | Hemoliance Factor X Deficient Plasma on ELECTRA Series Analyzers |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| K002400 | IL Test Factor X Deficient Plasma* on ACL Family of Analyzers |
| *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems, most<br>recently the ACL Advance. | |

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

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

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

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

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

### Summary of Performance Data:

### Method Comparison

In field site studies evaluating citrated plasma samples (normal and abnormal), the slopes and correlation coefficients (r) for HemosIL Factor X Deficient Plasma versus the predicate devices are shown below:

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

| IL System | n | Slope | r | PT Reagent Used |
|---------------|----|--------|--------|--------------------------|
| ELECTRA 1600C | 63 | 0.9461 | 0.9948 | RecombiPlasTin (K012768) |

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

| IL System | an and the first of the first of the first of the first of the first of the first of the first of the first for the first of the first for the first for the first for the fir | Slope | | PT Reagent Used |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|-------------------------------------|
| ACL 3000 | 62 | 1.0328 | 0.9849 | PT-Fibrinogen Recombinant (K981479) |
| ACL Futura | 62 | 1.0680 | 0.9840 | PT-Fibrinogen Recombinant (K981479) |

### 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 X | Within Run<br>CV% | Between Run<br>CV% |
|------------------|----------------------|--------------------|-------------------|--------------------|
| ACL 300 | Normal Control | 113.2 | 3.5 | 4.6 |
| | Low Abnormal Control | 38.9 | 4.1 | 6.0 |
| ACL 6000 | Normal Control | 114.0 | 3.3 | 4.3 |
| | Low Abnormal Control | 29.9 | 3.0 | 4.8 |
| ACL 9000 | Normal Control | 117.7 | 1.4 | 2.1 |
| | Low Abnormal Control | 27.1 | 1.9 | 4.4 |
| ACL Futura | Normal Control | 96.3 | 4.2 | 4.5 |
| | Low Abnormal Control | 38.9 | 5.0 | 6.1 |
| ELECTRA<br>1400C | Normal Control | 96.6 | 0.9 | 2.9 |
| | Low Abnormal Control | 27.5 | 1.7 | 2.4 |

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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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 9 2003

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

> k031122 Trade/Device Name: HemosIL Factor X Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: April 7, 2003 Received: April 8, 2003

Dear Ms. Marble:

Re:

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 X Deficient Plasma

Indications for Use:

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

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | K 031122 |
| 510(k) Number | |

| Prescription Use | |
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OR

| Over-The-Counter Use | |
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HemosIL Factor X Deficient Plasma 510(k)