VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

K022021 · Vital Scientific N.V. · GFO · Nov 1, 2002 · Hematology

Device Facts

• Record ID: K022021
• Device Name: VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
• Applicant: Vital Scientific N.V.
• Product Code: GFO · Hematology
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

Device Story

Vital Scientific APTT is an in-vitro diagnostic reagent; utilizes rabbit brain cephalin suspension with surface activator; added to patient plasma samples to initiate intrinsic coagulation pathway; measures time to fibrin clot formation. Used in clinical laboratories; operated by laboratory technicians/personnel. Reagent functions in conjunction with standard coagulometers (e.g., MLA 900C, ACL-100) to detect coagulation abnormalities; results assist clinicians in monitoring heparin therapy and diagnosing intrinsic pathway defects; provides quantitative clotting time data to inform clinical decision-making regarding anticoagulation management.

Clinical Evidence

Bench testing only. Correlation studies performed on 107 patient plasmas (30 normal, 77 heparin-treated) using MLA 900C (r=0.938) and ACL-100 (r=0.930) coagulometers. Precision studies (within-run and day-to-day) showed %CV < 5% for normal, low abnormal, and high abnormal controls, demonstrating equivalence to predicate.

Technological Characteristics

In-vitro diagnostic reagent; composition includes rabbit brain cephalin suspension and surface activator. Principle of operation: activation of intrinsic coagulation pathway to measure fibrin clot formation time. Form factor: liquid reagent for manual or automated laboratory use. No software or electronic components integral to the reagent itself; functions with external coagulometer hardware.

Indications for Use

Indicated for clinical laboratory use to detect coagulation abnormalities in the intrinsic pathway via Activated Partial Thromboplastin Time (APTT) testing.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• APTT-LS manufactured by Fisher Diagnostics (formerly Pacific Hemostasis) (K891337)

Reference Devices

• MLA 900C coagulometer (K884863)
• ACL-100 coagulometer (K881367)

Submission Summary (Full Text)

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NOV 1 2002

# vital scientific

USA: One Gateway Center, Suite 415 Newton, MA 02158
1-617-527-9933, Ext. 22 Fax: [phone]

NL: van Rensselaerweg 4, Spankeren 6956AV, NL
-31-313-43500 Fax:[phone]

### 510(k) Summary

Vital Scientific APTT

The assigned 510K number is: K022021

Applicant: Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158 Phone: [phone] x41 Fax: [phone]

Contact: Israel M. Stein MD

October 30, 2002 Date:

#### Device Name:

Vital Scientific APTT (In-vitro diagnostic reagent). The Vital Scientific APTT is also tradenamed the QuikCoag APTT, and APTT. References in this document submission may use these names interchangeably.

#### Common Name:

Activated Partial Thromboplastin Time (APTT)

#### Classification Name:

Activated Partial Thromboplastin - has been classified as Class II device, as per 21 CFR 864.7925 (Product Code GFO). This device is intended for clinical use in conjunction with an analyzer to measure clot formation.

#### Description of the APTT

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a

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modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

#### Intended Use

The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

#### Labeling:

This device is labeled in accordance with 21 CFR 801.

#### Substantial Equivalence:

The safety and effectiveness of APTT has been demonstrated by showing its substantial equivalence to APTT-LS manufactured by Fisher Diagnostics (formerly Pacific Hemostasis) K891337.

A correlation study was performed using a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The assays were performed on the MLA 900C coagulometer (K884863). The correlation coefficient for all plasmas was 0.938 and the slope is 0.727 and the intercept is 6.96, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.

Image /page/1/Figure/10 description: This image is a scatter plot titled "APTT reagent Correlation on MLA Electra 800C". The x-axis is labeled "Vital APTT clotting time (sec.)" and ranges from 20.0 to 80.0. The y-axis is labeled "Reference APTT-LS clotting time (sec.)" and ranges from 20.0 to 90.0. The data points show a positive correlation between the two APTT clotting times, and a trend line is drawn through the data.

A correlation study of these reagents was also performed on an ACL-100 coagulometer (K881367) in the clinical laboratory of a community hospital using

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October 30, 2002

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a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The correlation coefficient for all plasmas was 0.930, the slope was 0.952 and the intercept was 3.76, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.

Image /page/2/Figure/3 description: The figure is a scatter plot titled "APTT Correlation on ACL 100". The x-axis is labeled "BioMadica APTT" and ranges from 20 to 140. The y-axis is labeled "Pacific Hemostasis APTT-LS" and ranges from 20 to 120. There is a positive correlation between the two variables.

Day to Day and Within-run Precision studies were performed. All within-run %CV values were less than 5 %. The day to day precision is the %CV of the average APTT value obtained over five days. All day to day %CV values were less than 5%. The day to day and within run precision of Vital APTT and the predicate device APTT reagent were equivalent. The results for the within-run precision are shown in Table 1 and for the day to day precision is shown in Table 2 below:

| Controls | Vital APTT | | Reference APTT-LS | |
|-------------------|----------------|-------|-------------------|-------|
| | Average (n=16) | % CV | Average (n=16) | %CV |
| Normal | 24.2 | 1.1 % | 25.0 | 2.3 % |
| Low Abnormal | 43.3 | 4.3 % | 55.0 | 2.3 % |
| High Abnormal | 73.8 | 4.3 % | 94.7 | 2.4 % |
| Average Precision | | 3.2 % | | 2.3 % |

Table 1 Within-run Precision

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| | Vital APTT | | Reference APTT-LS | |
|-----------------|------------|-------|-------------------|-------|
| | Average | %CV | Average | %CV |
| Normal Control | | | | |
| Average (n=5) | 24.2 | 1.4 % | 25.0 | 2.4 % |
| Day to Day % CV | 3.6 % | | 0.2 % | |
| Low Abnormal | | | | |
| Average (n=5) | 41.9 | 2.7 % | 54.4 | 2.1 % |
| Day to Day % CV | 2.5 % | | 1.9 % | |
| High Abnormal | | | | |
| Average (n=5) | 70.2 | 3.3 % | 93.8 | 1.9 % |
| Day to Day % CV | 4.0 % | | 2.6 % | |

Table 2: Day to Day Precision

Vital Scientific concludes that the APTT has a similar intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution and is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Israel M. Stein, M.D. Managing Director Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158

Re: k022021

> Trade/Device Name: Vital Scientific APTT Regulation Number: 21 CFR 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: Class II Product Code: GFO Dated: September 30, 2002 Received: October 3, 2002

Dear Dr. Stein:

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/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): K022021

Device Name: Vital Scientific APTT

Indications For Use:

The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Thushine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K02262

Prescription Use (Per 21 CFR 801.109)

OR

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