VITAL SCIENTIFIC PT WITH CALCIUM

K020840 · Vital Scientific N.V. · GJS · May 15, 2002 · Hematology

Device Facts

• Record ID: K020840
• Device Name: VITAL SCIENTIFIC PT WITH CALCIUM
• Applicant: Vital Scientific N.V.
• Product Code: GJS · Hematology
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

Device Story

Vital Scientific PT with Calcium is an in-vitro diagnostic reagent; consists of lyophilized rabbit brain thromboplastin, calcium salt, buffers, and stabilizers. Used in clinical laboratories to perform Prothrombin Time (PT) testing and quantitative assays for coagulation factors II, V, VII, and X. Reagent added to patient blood samples to initiate extrinsic coagulation pathway; clot formation measured to determine clotting time. Results used by clinicians to monitor oral anticoagulant therapy and evaluate coagulation disorders. Provides quantitative data for clinical decision-making regarding patient anticoagulation status.

Clinical Evidence

Bench testing only. Correlation studies performed at a community hospital comparing subject device to predicate using normal, abnormal, and anticoagulant-treated patient samples. Results: correlation coefficient 0.92; INR slope 1.01, intercept 0.01. Precision studies (within-run and between-run) yielded CVs < 1%.

Technological Characteristics

Lyophilized rabbit brain thromboplastin, calcium salt, buffers, and stabilizers. In vitro diagnostic reagent. Principle: one-stage PT assay measuring extrinsic/common pathway coagulation. No electronic or software components.

Indications for Use

Indicated for in-vitro diagnostic performance of one-stage Prothrombin Time (PT) testing and PT-based factor assays (Factors II, V, VII, X) to monitor oral anticoagulant therapy and assess extrinsic/common coagulation pathways.

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

• Instrumentation Laboratory IL Test PT-Fibrinogen HS (K981479)

Submission Summary (Full Text)

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KO20840

## MAY 1 5 2002

### PREMARKET NOTIFICATION 510(K) SUMMARY

| Applicant: | Vital Scientific NV<br>One Gateway center<br>Suite 411<br>Newton, MA 02458<br>1(617) 527-9933 Ext 42<br>Fax:[phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Israel M. Stein MD |
| Date: | March 14, 2002 |
| Device Name: | Vital Scientific PT with Calcium<br>Quik Coag PT with Calcium<br>Vital Scientific PT<br>PT with Calcium |
| Common Name: | Prothrombin Time Test |
| Classification Name: | Prothrombin Time Test, 21 CFR section 864.7750 (GJS) |
| Comparison Device: | Instrumentation Laboratory Inc.<br>IL Test PT-Fibrinogen HS (K981479) |

### Description of the Device and Intended Use

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

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#### Summary of Substantial Equivalence Comparisons

The Vital Scientific PT with Calcium is substantially equivalent in intended use and performance to Instrumentation Laboratory IL Test PT-Fibrinogen HS (K981479).

Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VII and X (PT and PT-based factor assays). Both are in vitro tests which can be used for monitoring oral anticoagulant therapy.

In correlation studies, PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving anti-coagulant therapy, were tested using both reagent devices at a community hospital and yielded a correlation coefficient 0.92. The average values of the elevated PT samples were within one standard deviation of the predicate device average.

The systematic bias was eliminated when the results were converted to INR. The correlation using INR values, which corrects for differences in reagent sensitivity, shows a slope of 1.01 and the intercept 0.01. This indicates that the PT reagents provide the same INR value as any other calibrated PT reagent.

Within-run and between run precision studies were performed and CV's of less than 1% were obtained for the proposed device.

Vital Scientific NV, submits that the Vital Scientific PT with Calcium has the same intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 5 2002

Israel M. Stein, M.D. Managing Director Vital Scientific One Gateway Center, Suite 415 Newton, Massachusetts 02458

Re: k020840

Trade/Device Name: Vital Scientific PT with Calcium Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: March 14, 2002 Received: March 15, 2002

Dear Dr. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to Hay 2011 11:57 accordance with the provisions of the Federal Food, Drug, de rices unat in re been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may ; alerely mains of the Act include requirements for annual registration, listing of general connolo provisions of the tice, 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 If your device is exasting to words. Existing major regulations affecting your device can may oe subject to back additions, 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 I loast be advised that I Dr i blocative or our device complies with other requirements of the Act that I Dr has made a associations administered by other Federal agencies. You must or any I ecoral statutes and regarients, including, but not limited to: registration and listing (21 comply with an the Fee ore cart 801); good manufacturing practice requirements as set OI A ratt 6077; adoming (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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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you to or substantial equivalence of your device to a legally marketed nonlication. The I Dr I mining of vossification 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 additionally 60911 8 for questions on the promotion and advertising of your device, (2017) 594-4639. I reasonaliance at [phone]. Also, please note the regulation in 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 mormation on 90ar responser Assistance at its toll-free number [phone] or Manufacturers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_Q 30 8 40

Device Name: Vital Scientific PT

Indications For Use:

The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine-Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020 840

Prescription Use (Per 21 CFR 801.109) OR

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