DADE THROMBIN REAGENT

K050928 · Dade Behring, Inc. · KQJ · Jun 29, 2005 · Hematology

Device Facts

• Record ID: K050928
• Device Name: DADE THROMBIN REAGENT
• Applicant: Dade Behring, Inc.
• Product Code: KQJ · Hematology
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Intended Use

For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

Device Story

Dade Thrombin Reagent is a diagnostic reagent used to measure fibrinogen concentration in human plasma. It functions based on the Clauss method, where thrombin is added to dilute plasma to convert soluble fibrinogen into an insoluble fibrin clot. The time required for clot formation is inversely proportional to the fibrinogen concentration. The reagent is also used to accelerate coagulation in anticoagulated samples for immunohematology. It is intended for use by laboratory professionals in clinical settings. The output is a clotting time measurement, which is compared against a standardized fibrinogen preparation to determine the patient's fibrinogen level, aiding in the assessment of coagulation status.

Clinical Evidence

Method comparison study performed comparing the modified Dade Thrombin Reagent to the predicate. Study involved 80 samples per lot. Results showed high correlation (r=0.995 and r=0.993) with slopes of 1.03 and 0.946 respectively, demonstrating substantial equivalence in performance.

Technological Characteristics

Reagent-based fibrinogen determination system. Operates via enzymatic conversion of fibrinogen to fibrin clot. Class II device, product code KQJ. No software, electronics, or connectivity features.

Indications for Use

Indicated for the quantitative determination of fibrinogen in human plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.

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

• Dade Fibrinogen Determination Reagents kit (Pre-1976)
• Dade Thrombin Reagent (BK860038)

Submission Summary (Full Text)

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## 510(k) Summary for Dade® Thrombin Reagent

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K050928

### Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

Preparation date:

June 24, 2005

| 2. | Device Name | Dade® Thrombin Reagent and Dade® Owren's Veronal Buffer |
|----|-----------------|------------------------------------------------------------|
| | Classification: | Fibrinogen Determination System, Class II, 21 CFR 864.7340 |
| | Panel: | Hematology |
| | Product Code: | KQJ |

#### ldentification of the Legally Marketed Device: 3.

Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin Reagent (BK860038)

#### Device Description: 4.

Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.

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#### 5. Device Intended Use:

For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

#### Medical device to which equivalence is claimed and comparison information: 6.

The modified Dade Thrombin Reagent is substantially equivalent to the currently marketed Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin mancied Daoc The modified Dade Thrombin Reagent, like the current Dade Fibrinogen Determination Reagents kit is intended for use in the quantitative determination of fibrinogen in human plasma and to accelerate coagulation of anticoagulated samples for immunohematological studies.

#### Device Performance Characteristics: 7 .

### Method Comparison Study Dade® Fibrinogen Determination Reagents vs. Dade® Thrombin Reagent

| Dade® Thrombin<br>Reagent | (n=) | Slope | Intercept | Correlation<br>Coefficient |
|---------------------------|------|-------|-----------|----------------------------|
| SHP Lot # 502587 | 80 | 1.03 | -0.063 | 0.995 |
| SHP Lot # 502589 | 80 | 0.946 | -0.027 | 0.993 |

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JUN 2 9 2005
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

k050928 Re:

Trade/Device Name: Dade® Thrombin Reagent Regulation Number: 21 CFR § 864.7340 Regulation Name: System, Fibrinogen Determination Regulatory Class: II Product Code: KQJ Dated: April 13, 2005 Received: April 14, 2005

Dear Ms. Dray-Lyons:

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 for are cased a a 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 or any I odeful 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 Of It Fart 6077, acceming (21 the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form arketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleate 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, If you destions on the promotion and advertising of your device, please contact the Office of In of quotions on the promise Evaluation and Safety at [phone]. Also, please note the v tro Diagnoution . "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may obtain of Scherar ne 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 Beckerh

Robert L. Becker, Jr., MD, PAD 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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Dade Behring Inc. Dade® Thrombin Reagent 510(k) Notification - Modification

# Indications Statement

K050928

Device Name:

Dade® Thrombin Reagent

Indications for Use:

muleations for Goo.
For use in the quantitative determination of fibrinogen in plasma and to accelerate r or ass in the quantically ated samples for immunohematology studies.

Prescription Use
(Per 21 CFR 801 Subpart D)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

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

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