HEMOSIL FACTOR VIII DEFICIENT PLASMA

K034007 · Instrumentation Laboratory CO · GJT · Feb 13, 2004 · Hematology

Device Facts

• Record ID: K034007
• Device Name: HEMOSIL FACTOR VIII DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII; used for quantitative determination of factor VIII activity in citrated patient plasma. Device operates on IL Coagulation and ELECTRA systems using modified activated partial thromboplastin time (APTT) assay. Patient plasma is diluted and mixed with deficient plasma; clotting time correction is proportional to factor VIII concentration. Results are interpolated from calibration curve. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing intrinsic pathway factor abnormalities and managing factor VIII deficiencies.

Clinical Evidence

Bench testing only. Method comparison studies performed on ~60 citrated plasma samples (30 normal, 30 abnormal) comparing subject device to predicates on various IL systems (ACL 300, ACL Advance, E1400C). Results showed strong correlation (r=0.9873 to 0.9942) and slopes (0.9391 to 1.0073). Precision assessed over 80 runs; within-run CV% ranged 2.2-4.8%, between-run CV% ranged 3.1-6.0%.

Technological Characteristics

Human plasma immunodepleted of factor VIII. Reagent for use in APTT-based coagulation assays. Compatible with IL Coagulation and ELECTRA systems. No specific materials or software algorithms described; functions as a biological reagent in automated coagulation analyzers.

Indications for Use

Indicated for in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma using APTT assay on IL Coagulation and ELECTRA systems. Patient population includes individuals requiring assessment of intrinsic pathway factor abnormalities.

Predicate Devices

• Hemoliance Factor VIII Deficient Plasma (K893525)
• IL Test Factor VIII Deficient Plasma (K002400)

Submission Summary (Full Text)

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## Section 3 HemosIL Factor VIII 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 Director Phone: [phone] / Fax: [phone]

#### Summary Prepared:

December 23, 2003

### Name of the Device:

HemosIL Factor VIII Deficient Plasma

### Classification Name(s):

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

### Identification of Predicate Device(s):

- K893525 Hemoliance Factor VIII Deficient Plasma on ELECTRA Series Analyzers
- K002400 IL Test Factor VIII 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 VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.

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

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

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# Section 3 HemosIL Factor VIII 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 and 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VIII Deficient Plasma versus the predicate devices are shown below:

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

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

| IL System | n | Slope | r |
|-----------|----|--------|--------|
| E1400C | 59 | 0.9518 | 0.9873 |

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

| IL System | n | Slope | r |
|-------------|----|--------|--------|
| ACL 300 | 60 | 0.9391 | 0.9942 |
| ACL Advance | 63 | 1.0073 | 0.9906 |

#### 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 and SynthASil) and both normal and abnormal samples.

| Instrument | Control | Mean<br>% Factor VIII | Within run<br>CV% | Between Run<br>CV% |
|------------------|----------------------|-----------------------|-------------------|--------------------|
| ACL 9000 | Normal Control | 72.6 | 3.1 | 3.1 |
| ACL 9000 | Low Abnormal Control | 32.2 | 2.2 | 3.3 |
| ACL Futura | Normal Control | 78.3 | 2.7 | 3.6 |
| ACL Futura | Low Abnormal Control | 31.5 | 3.4 | 4.0 |
| ELECTRA<br>1600C | Normal Control | 93.9 | 4.8 | 6.0 |
| ELECTRA<br>1600C | Low Abnormal Control | 37.2 | 4.1 | 4.6 |

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Re:

FEB 1 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

> k034007 Trade/Device Name: HemosIL Factor VIII Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Plasma, Coagulation Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: December 23, 2003 Received: December 24, 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 I'DA 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,

Joseph L. Arblett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices 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): Kø 3 4007

Device Name: HemosIL Factor VIII Deficient Plasma

### Indications for Use:

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|---------|----|----------------------|
| Division Sign-Off | | | |
| Office of In Vitro Diagnostic Device | | | |
| Evaluation and Safety | | | |
| 510(k) | K034007 | | |
| Prescription Use | | OR | Over-The-Counter Use |

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