MDA SIMPLASTIN HTF

K974566 · Organon Teknika Corp. · GJS · Feb 24, 1998 · Hematology

Device Facts

• Record ID: K974566
• Device Name: MDA SIMPLASTIN HTF
• Applicant: Organon Teknika Corp.
• Product Code: GJS · Hematology
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.

Device Story

MDA® Simplastin® HTF is a tissue thromboplastin reagent used in clinical laboratories to determine prothrombin time (PT) in anticoagulated human plasma. The reagent is derived from cultured human cells. In operation, the reagent is added to patient plasma samples to initiate clot formation. The time required for clot formation is measured, providing a diagnostic indicator of the extrinsic coagulation pathway. Results are used by clinicians to assess coagulation status and monitor therapy. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Clinical evidence includes method comparison studies for PT, INR, and coagulation factors (II, V, VII, X) against the predicate device. Precision studies were conducted on normal, borderline abnormal, and coumadin plasma pools. Interference studies evaluated lipemic, icteric, and hemolyzed samples. Heparin tolerance was assessed using heparin-spiked plasma. Reference ranges were established using normal plasma pools. Results support substantial equivalence.

Technological Characteristics

Tissue thromboplastin reagent derived from cultured human cells. Principle of operation: clot formation assay. Preservative: nitrobromodioxide. Intended for use with anticoagulated human plasma. No electronic or software components.

Indications for Use

Indicated for the determination of prothrombin time (PT) in human plasma for patients requiring coagulation monitoring.

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

• Ortho RecombiPlasTin® Reagent

Submission Summary (Full Text)

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K974566

510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

FEB 24 1908

..

# 510(k) Summary MDA@Simplastin® HTF

## The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;

Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA

Submitter's Telephone: [phone]

Submitter's Contact: Rebecca Rivas

Date 510(k) Summary Prepared: 12/4/97

### The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known;

Trade or Proprietary Name: MDA®Simplastin® HTF

Common or Usual Name: Thromboplastin reagent

Classification Name: Prothrombin time test

### An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;

Device Equivalent to: Ortho RecombiPlasTin® Reagent

#### A description of the device. (a)(4)

Device Description: Tissue Thromboplastin reagent for use in determination of the prothrombin (PT) in human plasma.

#### (a)(5) A statement of the intended use of the device.

Device Intended Use: Determination of the prothrombin time (PT) in human plasma.

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## 510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

## A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.

| Assay Feature | MDA®Simplastin® HTF | Ortho<br>RecombiPlasTin® |
|---------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Thromboplastin Source | Cultured Human Cells | Recombinant Human<br>Tissue Factor |
| Intended Use | Determination of<br>Prothrombin time in<br>human plasma | Determination of<br>Prothrombin time in human<br>plasma |
| Samples | Anticoagulated Plasma | Anticoagulated<br>Plasma |
| Technology | Clot formation | Clot formation |
| Normal Patient Mean(sec.) | 12.1 seconds | 11.7 second |
| Preservative | Nitrobromodioxide | Sodium Azide |
| Controls | Routine Coagulation | Routine Coagulation |

## A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics of the new device including: Precision studies on three levels of plasma controls, and open vial stability studies.

## A brief discussion of the clinical tests submitted, referenced, or relied on in the (b)(2) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics and substantial equivalence of the new device including: Prothrombin Time method comparison; INR method comparisons; Factor II,V,VII and X method comparison; precision studies on normal plasma pool, borderline abnormal plasma pool and coumadin plasma pool; interference studies on lipemic, icteric and hemolyzed samples; reference ranges on normal plasma pool; and heparin tolerance evaluation utilizing heparin spiked plasma samples.

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## 510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

## The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The data shown in this submission supports:

- The safety and efficacy of MDA® Simplastin® HTF through the following studies: 1. precision studies on controls and clinical specimens, interference studies utilizing clinical specimens, normal donor reference range and open vial stability data.
- Substantial equivalence to the predicate device Ortho RecombiPlasTin® through the 2. following studies: method comparisons for Prothrombin times, INR values; Factor II; Factor V; Factor VII; and Factor X all utilizing clinical specimens.

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Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle's head and neck, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 4 1998

Rebecca A. Rivas Requlatory Affairs Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

Re : K974566 MDA® Simplastin® HTF Requlatory Class: II Product Code : ... GJS ... ... Dated: December 4, 1997 December 5, 1997 Received:

Dear Ms. Rivas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current-Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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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510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HT

510(k) Number (If known): <994566

Device Name: MDA®SinplastiN® HTF

Indications For Use:

MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Lab 510(k) Number Over-The-Counter OR Prescription Use v Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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