HEMOSIL FACTOR XI DEFICIENT PLASMA

K030287 · Instrumentation Laboratory CO · GJT · Mar 19, 2003 · Hematology

Device Facts

• Record ID: K030287
• Device Name: HEMOSIL FACTOR XI DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Mar 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

HemosIL Factor XI Deficient Plasma consists of human plasma immunodepleted of Factor XI. Used in clinical laboratories to determine Factor XI activity in patient citrated plasma samples. Principle of operation: modified activated partial thromboplastin time (APTT) assay. Patient plasma is diluted and mixed with Factor XI deficient plasma; clotting time correction is measured. Resulting clotting time is compared against a calibration curve to interpolate Factor XI concentration (% activity). Output provides quantitative Factor XI activity levels to assist clinicians in diagnosing intrinsic pathway factor deficiencies. Device is intended for professional use on IL Coagulation and ELECTRA systems.

Clinical Evidence

Bench testing only. Method comparison studies performed on ~60 citrated plasma samples (30 normal/30 abnormal) across various IL and ELECTRA systems. Correlation coefficients (r) ranged from 0.9669 to 0.9886; slopes ranged from 0.9512 to 1.0093. Precision assessed over 80 runs; within-run CVs ranged from 2.4% to 5.4%, between-run CVs ranged from 4.4% to 9.7%.

Technological Characteristics

Human plasma immunodepleted of Factor XI. Reagent used in conjunction with APTT-SP or SynthASil reagents on automated coagulation analyzers. Quantitative measurement based on clotting time interpolation.

Indications for Use

Indicated for in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma for patients requiring assessment of intrinsic pathway factor abnormalities. Used by clinical laboratory professionals on IL Coagulation and ELECTRA systems.

Predicate Devices

• Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers (K893536)
• IL Test Factor XI Deficient Plasma (K002400)

Submission Summary (Full Text)

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# Section 3 HemosIL Factor XI 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:

January 27, 2003

## Name of the Device:

HemosIL Factor XI Deficient Plasma

## Classification Name(s):

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

## Identification of Predicate Device(s):

Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers K893536

IL Test Factor XI 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 XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in Factor XI. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor XI in the patient plasma, interpolated from a calibration curve.

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

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

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

# Summary of Performance Data:

## Method Comparison

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

NOTE: IL Test APTT-SP and SynthASil were used as the APTT reagents in all testing.

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

| IL System | Slope | r |
|-----------|--------|--------|
| E1400C | 1.0063 | 0.9808 |

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

| IL System | Slope | r |
|------------|--------|--------|
| ACL 300 | 0.9605 | 0.9886 |
| ACL 6000 | 1.0093 | 0.9669 |
| ACL 9000 | 0.9512 | 0.9857 |
| ACL Futura | 0.9924 | 0.9722 |

## Within Run Precision

Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of APTT reagent (SynthASil on ELECTRA and APTT-SP on IL Coagulation Systems) and both normal and abnormal samples.

| Instrument | Control | Mean<br>% Factor XI | Within run<br>CV% | Between Run<br>CV% |
|------------------|----------------------|---------------------|-------------------|--------------------|
| ACL 300 | Normal Control | 81.0 | 4.5 | 4.4 |
| ACL 300 | Low Abnormal Control | 41.1 | 4.0 | 5.6 |
| ACL 6000 | Normal Control | 77.1 | 3.5 | 4.7 |
| ACL 6000 | Low Abnormal Control | 40.9 | 5.4 | 7.4 |
| ACL 9000 | Normal Control | 100.5 | 4.5 | 9.7 |
| ACL 9000 | Low Abnormal Control | 49.8 | 4.8 | 7.5 |
| ACL Advance | Normal Control | 97.9 | 4.6 | 7.5 |
| ACL Advance | Low Abnormal Control | 54.2 | 4.6 | 5.5 |
| ELECTRA<br>1400C | Normal Control | 136.7 | 2.4 | 6.8 |
| ELECTRA<br>1400C | Low Abnormal Control | 71.7 | 2.9 | 6.6 |

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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 the department's symbol, which is a stylized caduceus with three intertwined snakes forming a human profile. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2003

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

Re: k030287 Trade/Device Name: HemosIL Factor XI Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: January 24, 2003 Received: January 28, 2003

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): k030387

Device Name: HemosIL Factor XI Deficient Plasma

# Indications for Use:

HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of factor XI and intended for the in vitro diagnostic quantitative determination of factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) 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) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K030287 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use | |
|------------------|-----------------------------------------|----|----------------------|--|
|------------------|-----------------------------------------|----|----------------------|--|