HEMOSIL FACTOR IX DEFICIENT PLASMA

K031829 · Instrumentation Laboratory CO · GJT · Jul 31, 2003 · Hematology

Device Facts

• Record ID: K031829
• Device Name: HEMOSIL FACTOR IX DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Jul 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

HemosIL Factor IX Deficient Plasma consists of human plasma immunodepleted of Factor IX. Used in clinical laboratories on IL Coagulation and ELECTRA systems to perform modified activated partial thromboplastin time (APTT) assays. Patient plasma is diluted and mixed with the deficient plasma; the degree of correction of the clotting time is proportional to the Factor IX activity in the patient sample. Results are interpolated from a calibration curve to quantify Factor IX activity. This quantitative determination aids clinicians in diagnosing and monitoring intrinsic pathway factor abnormalities. The device provides standardized reagents for automated coagulation analyzers, facilitating consistent diagnostic testing.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison studies against predicate devices on multiple analyzer systems (ACL 3000, E1600C). Results demonstrated strong correlation (r=0.9584 to 0.9793) and slopes (1.0049 to 1.1076). Precision assessed over 80 runs using normal and abnormal controls; within-run CVs ranged from 2.3% to 8.8%, and between-run CVs ranged from 2.6% to 8.3%.

Technological Characteristics

Human plasma immunodepleted of Factor IX. Principle of operation: modified APTT assay. Form factor: liquid reagent for use on automated coagulation analyzers (IL Coagulation and ELECTRA systems).

Indications for Use

Indicated for in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma for patients requiring assessment of intrinsic pathway factor abnormalities. Used on IL Coagulation and ELECTRA Systems.

Predicate Devices

• Hemoliance Factor IX Deficient Plasma (K893524)
• IL Test Factor IX Deficient Plasma (K002400)

Submission Summary (Full Text)

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Ko3/829

# Section 3 HemosIL Factor IX 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:

June 12, 2003

#### Name of the Device:

HemosIL Factor IX Deficient Plasma

#### Classification Name(s):

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

### Identification of Predicate Device(s):

K893524 Hemoliance Factor IX Deficient Plasma on ELECTRA Series Analyzers K002400 IL Test Factor IX Deficient Plasma* on ACL Family of Analyzers *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 IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX 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 IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.

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

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

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#### Section 3

## HemosIL Factor IX Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)

#### Summary of Performance Data:

#### Method Comparison

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

NOTE: APTT-C and SynthASil were used as the APTT reagents in testing.

#### HemosIL Factor IX Deficient Plasma vs. Predicate Hemoliance Factor IX Deficient Plasma on ELECTRA IT Cast ci

| IL System | n | Slope | r |
|-----------|----|--------|--------|
| E1600C | 65 | 1.0049 | 0.9584 |

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

| IL System | n | Slope | r |
|-----------|----|--------|--------|
| ACL 3000 | 76 | 1.1076 | 0.9793 |

#### 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 (APTT-SP or SynthASil) and both normal and abnormal samples.

| Instrument | Control | Mean<br>% Factor IX | Within run<br>CV% | Between Run<br>CV% |
|------------------|----------------------|---------------------|-------------------|--------------------|
| ACL 6000 | Normal Control | 102.3 | 5.8 | 2.6 |
| ACL 6000 | Low Abnormal Control | 24.2 | 8.5 | 4.1 |
| ACL 9000 | Normal Control | 121.2 | 3.0 | 3.8 |
| ACL 9000 | Low Abnormal Control | 32.8 | 2.3 | 5.9 |
| ACL Futura | Normal Control | 118.2 | 4.4 | 2.9 |
| ACL Futura | Low Abnormal Control | 38.2 | 6.0 | 2.7 |
| ELECTRA<br>1400C | Normal Control | 111.5 | 8.4 | 8.3 |
| ELECTRA<br>1400C | Low Abnormal Control | 28.9 | 8.0 | 7.6 |
| ELECTRA<br>1800C | Normal Control | 119.2 | 8.8 | 5.7 |
| ELECTRA<br>1800C | Low Abnormal Control | 30.2 | 8.8 | 6.4 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Ms. Carol Marble Regulatory Affairs Manager JUL 3 1 2003 Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k031829

Trade/Device Name: HemosIL Factor IX Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT, GGP Dated: June 12, 2003 Received: June 13, 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. Iisting 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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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,

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 IX Deficient Plasma

Indications for Use:

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

Quitte y. Michane C m.D. FOR J. BAPTISTA

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