DADE THROMBOPLASTIN C PLUS

K013155 · Dade Behring, Inc. · GJS · Jan 18, 2002 · Hematology

Device Facts

• Record ID: K013155
• Device Name: DADE THROMBOPLASTIN C PLUS
• Applicant: Dade Behring, Inc.
• Product Code: GJS · Hematology
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays.

Device Story

Dade® Thromboplastin C Plus is a lyophilized reagent containing dried rabbit brain, calcium, and stabilizers. Used in clinical laboratories to initiate clotting via the extrinsic common pathway. Input consists of citrated human plasma samples; device transforms these into a clotting time measurement. Used on automated coagulation analyzers to detect single or combined deficiencies of the extrinsic coagulation system. Output is a prothrombin time (PT) value or derived fibrinogen concentration. Healthcare providers use these results to monitor oral anticoagulation therapy and diagnose coagulation disorders, facilitating clinical management of patient hemostasis.

Clinical Evidence

Method comparison studies performed on 103-176 samples across multiple photo-optical coagulation analyzers (BCT, BCS, Sysmex CA-1500, CA-6000, CA-500). Correlation coefficients (r) ranged from 0.935 to 0.975. Precision studies on the Sysmex CA-1500 showed total %CV between 1.1% and 5.4% across various control levels (CPN, CPP, NPP, PPP).

Technological Characteristics

Lyophilized reagent composed of dried rabbit brain, calcium, and stabilizers. Operates via extrinsic common pathway initiation. Designed for use with photo-optical coagulation analyzers. No specific materials standards or software architecture details provided.

Indications for Use

Indicated for determination of prothrombin time (PT) and PT-based assays in patients requiring assessment of the extrinsic coagulation system, including monitoring of oral anticoagulation therapy and detection of hereditary or acquired coagulation disorders.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• Multifibren™ U (K934326)

Submission Summary (Full Text)

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## JAN 1 8 2002

K013155

## 510(k) Summary of Safety and Effectiveness Dade® Thromboplastin C Plus September 20, 2001

Dade Behring Inc. 13251 NW 9th Terrace Miami, FL 33182 Contact Person: Radames Riesgo at 305.480.7558 or by facsimile at 305.552.5288.

| Trade or Proprietary Name: | Dade® Thromboplastin C Plus |
|----------------------------|-------------------------------------------|
| Common or Usual Name: | Prothrombin time assay |
| Classification Name: | Prothrombin Time Test (21 CFR § 864.7750) |
| Registration Number: | Location |

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

9610806

Distributor Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

2517506

The modified product is an in vitro diagnostic test for the determination of prothrombin time and prothrombin time-based assays. Dade® Thromboplastin C Plus is a lyophilized preparation of dried rabbit brain with calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.

Dade® Thromboplastin C Plus is substantially equivalent in intended use for fibrinogen determination to Multifibren™ U (K934326). Both the proposed product and the predicate device are intended to provide results of the fibrinogen concentration present in citrated human plasma.

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Comparative performance studies involving different photo-optical coagulation analyzers were conducted to evaluate the performance of both reagents for the determination of fibrinogen concentration in specimens.

The results of the performance studies are summarized in the tables below.

| Analyzers | Sample<br>Number (n) | Coefficient of<br>Correlation (r) | Regression<br>Equation |
|---------------------|----------------------|-----------------------------------|------------------------|
| BCTTM/BCTTM | 171 | 0.951 | Y = 1.03X - 0.40 |
| BCSTM/BCTTM | 165 | 0.935 | Y = 1.09X - 0.59 |
| Sysmex® CA-1500/BCT | 166 | 0.965 | Y = 1.09X - 0.32 |
| Sysmex® CA-6000/BCT | 103 | 0.943 | Y = 1.08X - 0.65 |
| Sysmex® CA-500/BCT | 176 | 0.975 | Y = 1.12X - 0.41 |

## Summary of Method Comparison Studies between Dade® Thromboplastin C Plus and Multifibren™ U

## Summary of Precision Study Derived Fibrinogen Determination on Sysmex® Automated Coagulation Analyzer CA-1500

| Assay | Control<br>Level | n | Mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV | Max.<br>Error<br>Criteria<br>%CV |
|-----------------------------------------------------------|------------------|----|------|----------------------|-----------------------|--------------|----------------------------------|
| Derived Fibrinogen<br>(Dade®<br>Thromboplastin C<br>Plus) | CPN | 40 | 1.8 | 5.5 | 1.6 | 5.4 | 10 |
| | CPP | 40 | 0.7 | 1.1 | 0.4 | 1.1 | |
| | NPP | 40 | 2.9 | 4.6 | 1.7 | 4.6 | |
| | PPP | 40 | 4.6 | 4.7 | 1.1 | 4.5 | |

CPN: Control Plasma N CPP: Control Plasma P NPP: Normal plasma pool PPP: Pathological plasma pool

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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Director, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site, P.O. Box 6101 Newark, DE 19714-6101

JAN 1 8 2002

Re: k013155

Trade/Device Name: Dade® Thromboplastin C Plus Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: December 13, 2001 Received: December 14, 2001

Dear Ms. Ayash:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Korziss 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Dade® Thromboplastin C Plus

Indications for Use:

Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays. '

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Bautista

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K013153

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)