HEMOSIL FACTOR XII DEFICIENT PLASMA

K043459 · Instrumentation Laboratory CO · GJT · Feb 9, 2005 · Hematology

Device Facts

• Record ID: K043459
• Device Name: HEMOSIL FACTOR XII DEFICIENT PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

HemosIL Factor XII Deficient Plasma is intended for the quantitative determination of factor XII activity on IL and ELECTRA Coagulation Systems.

Device Story

HemosIL Factor XII Deficient Plasma is an immunodepleted human plasma reagent used for in vitro diagnostic testing. It is utilized in clinical laboratories on IL Coagulation and ELECTRA systems to measure Factor XII activity. The device functions by mixing patient citrated plasma with the Factor XII-deficient plasma; the resulting clotting time, measured via an APTT assay, is compared against a calibration curve to determine the percentage of Factor XII activity. This quantitative output assists clinicians in diagnosing intrinsic pathway coagulation factor abnormalities. The device provides a standardized reagent for automated coagulation analyzers, facilitating accurate assessment of patient coagulation profiles.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical bench testing and method comparison studies. Precision studies (n=80 and n=40) across multiple instrument/reagent combinations showed total CVs between 5.3% and 5.6%. Method comparison studies (n=70 and n=60) against predicate devices demonstrated correlation coefficients (r) of 0.971 to 0.986, meeting the acceptance criterion of ≥ 0.95. Reagent comparison studies (n=56) confirmed performance across various APTT reagents.

Technological Characteristics

Lyophilized human plasma immunodepleted of factor XII. Quantitative clotting assay based on APTT. Compatible with IL Coagulation and ELECTRA Systems. Reconstituted stability: 24 hours at 2-8°C. Analyte: Factor XII activity.

Indications for Use

Indicated for the quantitative determination of Factor XII activity in citrated human plasma using APTT-based assays on IL Coagulation and ELECTRA systems. Intended for use in clinical laboratory settings for patients requiring assessment of intrinsic pathway factor abnormalities.

Predicate Devices

• Hemoliance Factor XII Deficient Plasma on the ELECTRA Series Analyzers (K893534)
• HemosIL Factor XII Deficient Plasma on the ACL Family of Analyzers (K002400)

Submission Summary (Full Text)

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K043559

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

### Submitted by:

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

## Contact Person:

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

## Summary Prepared:

December 14, 2004

#### Name of the Device:

HemosIL Factor XII Deficient Plasma

#### Regulatory Information:

| Regulation Section: | Factor Deficiency Test (864.7290) |
|---------------------|-----------------------------------|
| Classification: | Class II |
| Product Code: | GJT |
| Panel: | Hematology |

## Identification of Predicate Device(s):

| K893534 | Hemoliance Factor XII Deficient Plasma on ELECTRA Series Analyzers |
|-------------------------------------------------------------------|--------------------------------------------------------------------|
| K002400 | HemosIL Factor XII Deficient Plasma* on ACL Family of Analyzers |
| *NOTE: FDA cleared as part of the each ACL instrument 510(k): for | |
| example, the ACL Advance (K002400) | |

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

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

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

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

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

## Summary of Performance Data:

## Method Comparison

In an in-house method comparison study evaluating approximately 70 citrated plasma samples, the slopes and correlation coefficients (r) for HemosIL Factor XII Deficient Plasma versus the predicate devices are shown below:

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

# New HemosIL Factor XII Deficient Plasma vs. Predicate HemosIL Factor XII Deficient Plasma on ACL Family

| IL System | n | Slope | r |
|-------------|----|--------|--------|
| ACL 3000 | 71 | 0.9284 | 0.9882 |
| ACL 10000 | 71 | 0.9116 | 0.9704 |
| ACL Advance | 70 | 1.0065 | 0.9687 |
| ACL TOP | 72 | 1.0739 | 0.9551 |

# New HemosIL Factor XII Deficient Plasma vs. Predicate Hemoliance Factor XII Deficient Plasma on ELECTRA

| IL System | n | Slope | r |
|-----------|----|--------|--------|
| E1600C | 73 | 0.9918 | 0.9863 |

## 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 controls.

| Instrument | Control | Mean<br>% Factor XII | Within run<br>%CV | Between Run<br>%CV |
|------------------|------------------------------|----------------------|-------------------|--------------------|
| ACL 9000 | Normal Control | 100.0 | 1.9 | 3.4 |
| ACL 9000 | Special Test Control Level 2 | 30.4 | 2.6 | 3.3 |
| ACL Futura | Normal Control | 95.1 | 3.0 | 2.9 |
| ACL Futura | Special Test Control Level 2 | 31.4 | 2.3 | 3.8 |
| ACL TOP | Normal Control | 103.0 | 4.7 | 3.1 |
| ACL TOP | Special Test Control Level 2 | 33.9 | 6.1 | 3.2 |
| ELECTRA<br>1600C | Normal Control | 102.4 | 3.4 | 7.8 |
| ELECTRA<br>1600C | Special Test Control Level 2 | 36.0 | 3.5 | 4.3 |

HemosIL Factor XII Deficient Plasma 510(k)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

FEB - 9 2005

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

Re: k043459

> Trade/Device Name: HemosIL Factor XII Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Plasma, coagulation deficient Regulatory Class: II Product Code: GJT Dated: December 14, 2004 Received: December 15, 2004

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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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/industry/support/index.html

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology 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 XII Deficient Plasma

# Indications for Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-
(21 CFR 8

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K043459

HemosIL Factor XII Deficient Plasma 510(k)