HEMOSIL FIBRINOGEN-C

K073367 · Instrumentation Laboratory CO · KQJ · Dec 27, 2007 · Hematology

Device Facts

• Record ID: K073367
• Device Name: HEMOSIL FIBRINOGEN-C
• Applicant: Instrumentation Laboratory CO
• Product Code: KQJ · Hematology
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Intended Use

HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.

Device Story

HemosIL Fibrinogen-C reagent modification for use on ACL TOP instrument; optimizes test parameters including reflex testing, direct dilution, and incubation time; expands linearity and interference claims; intended for clinical laboratory use to measure fibrinogen levels; provides quantitative results to healthcare providers for coagulation assessment.

Clinical Evidence

Bench testing only. Performance data compared current and modified parameters on the ACL TOP system. Linearity was expanded from 80-700 mg/dL to 35-1000 mg/dL. Precision studies showed improved within-run CVs (Normal: 4.5% vs 7.9%; Low: 5.1% vs 7.7%). Interference testing confirmed performance for Heparin, Hemoglobin, and Bilirubin; FDP interference was identified and addressed via labeling updates.

Technological Characteristics

In vitro diagnostic reagent kit; Clauss method (thrombin-based coagulation assay). Designed for use on IL Coagulation Systems (ACL TOP). Optimized math model and incubation parameters. Linearity range: 35-1000 mg/dL.

Indications for Use

Indicated for quantitative determination of fibrinogen in human citrated plasma using the Clauss method on IL Coagulation Systems for in vitro diagnostic use.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• HemosIL Fibrinogen-C (K931721)

Submission Summary (Full Text)

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K073367

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

#### Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207

Prepared:

November 29, 2007

#### Device Name:

HemosIL Fibrinogen-C

#### Regulatory Information:

| KQJ | System, Fibrinogen Determination | | | |
|----------|----------------------------------|----------|--|--|
| 864.7340 | Fibrinogen Determination System | Class II | | |

#### Predicate Device:

K931721 HemosIL Fibrinogen-C

#### Device Intended Use:

HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

#### Device Description:

The Fibrinogen-C kit uses an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of the fibrinogen concentration.

#### Reason for Submission:

The HemosIL Fibrinogen-C test parameters on the ACL TOP are being modified as follows:

- . Separate low-end and high-end reflex test parameters are being added to expand the linearity claims on the ACL TOP from the current labeled 80-700 mg/dL to 35-1000 mg/dL.
- . The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).
- The robustness of the assay is increased by optimizing the incubation time and math model. .

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

The performance of the optimized test parameters for HemosIL Fibrinogen-C on the ACL TOP is substantially equivalent to the performance of the current legally marketed test parameters.

- . There are no changes in the reagent's intended use, formulation or operating principle and no changes to the instrument system software, intended use, operating principle or labeled performance claims with this submission.
DEC 2 7 2007

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# 510(k) Summary (Cont.)

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### Summary of Performance Data:

| Limitations | | | | | | |
|--------------------|----------------------------------------------------|-----------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|---------------|
| Current Parameters | | | Modified Parameters | | | |
| No Interference | | | | | | |
| • | Heparin | Up to 1 U/mL | • | Heparin | Up to 1 U/mL | |
| • | Hemoglobin | Up to 375 mg/dL | • | Hemoglobin | Up to 375 mg/dL | |
| • | Triglycerides | Up to 890 mg/dL | • | Triglycerides | Up to 750 mg/dL | |
| • | Bilirubin | Up to 21 mg/dL | • | Bilirubin | Up to 21 mg/dL | |
| • | Fibrinogen Degradation Products<br>Up to 100 µg/mL | | • | Fibrinogen Degradation Products:<br>New testing showed interference from FDP.<br>Therefore, the insert will indicate that<br>Fibrinogen-C assay results on the ACL TOP<br>may be affected by degradation products<br>(fibrin or fibrinogen) in the plasma assayed.<br>This statement is consistent with the<br>language already in use for the other ACL<br>instrument platforms. An associated<br>literature reference regarding FDP<br>interference will be added. | | |
| Precision | | | | | | |
| Current Parameters | | | Modified Parameters | | | |
| Control Level | Mean | Within Run CV | | Control Level | Mean | Within Run CV |
| Normal | 365 mg/dL | 7.9% | | Normal | 303 mg/dL | 4.5% |
| Low Fibrinogen | 93 mg/dL | 7.7% | | Low Fibrinogen | 107 mg/dL | 5.1% |
| Linearity | | | | | | |
| Current Parameters | | | Modified Parameters | | | |
| 80 - 700 mg/dL | | | 35 - 1000 mg/dL | | | |

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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 consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA". The text is arranged around the circumference of the circle, with the bird symbol placed in the center.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 7 2007

Instrumentation Laboratory Co. C/O Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421

Re: k073367

Trade/Device Name: Hemosil Fibrinogen-C Regulation Number: 21 CFR 864.7340 Regulation Name: Fibrinogen Determination System Regulatory Class: Class II Product Code: KQJ Dated: November 29, 2007 Received: November 30, 2007

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

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Page 2 - Instrumentation Laboratory Co.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Tabat Broderf

Robert L. Becker, Jr., M.D., 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 Fibrinogen-C

Indications for Use:

HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

For in vitro diagnostic use.

ﮯ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ____________ (21 CFR 801 Subpart C)

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

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

Jacqueline Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Ko73367

Special 510(k): HemosIL Fibrinogen-C