VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

K022046 · Vital Scientific N.V. · GGN · Jul 23, 2002 · Hematology

Device Facts

• Record ID: K022046
• Device Name: VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
• Applicant: Vital Scientific N.V.
• Product Code: GGN · Hematology
• Decision Date: Jul 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Coagulation Controls Levels 1, 2, and 3 are intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 vields results in the moderately abnormal range. Level 3 is intended to vield results in the extremely abnormal range.

Device Story

Coagulation Control Levels 1, 2, and 3 are lyophilized, citrated plasma preparations derived from healthy donors; processed with added buffer and stabilizer. Used in clinical laboratory settings by technicians to monitor performance of PT and APTT coagulation assays. Controls serve as reference points to verify instrument/reagent accuracy; Level 1 represents normal range; Level 2 represents moderately abnormal range; Level 3 represents extremely abnormal range. Healthcare providers use these controls to validate daily testing reliability, ensuring patient coagulation results are accurate and clinically actionable. Plasma is certified negative for HBsAG, HIV antibodies, and HCV antibodies.

Clinical Evidence

Bench testing only. Precision studies (within-run and between-run) conducted with n=20 samples per level. Compared PT and APTT performance against predicate controls. Results demonstrated comparable precision (CV%) across normal, low abnormal, and high abnormal ranges.

Technological Characteristics

Lyophilized citrated plasma; includes buffer and stabilizer. Multi-level (1, 2, 3) formulation for PT/APTT monitoring. In vitro diagnostic reagent. No electronic or software components.

Indications for Use

Indicated for clinical use as an in-vitro diagnostic control to monitor Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT) coagulation testing performance. Levels 1, 2, and 3 provide normal, moderately abnormal, and extremely abnormal ranges, respectively.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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

• Precision Biologic Pooled Normal Plasma (K952662)
• Assess Low Abnormal Control from Instrumentation laboratory (K931117)
• Assess High Abnormal Control from Instrumentation Laboratory (K931118)

Reference Devices

• MLA-900C Coagulometer (K884863)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Vital Scientific. The logo consists of a stylized graphic to the left of the company name. The company name, "vital scientific", is written in a sans-serif font, with the word "vital" in a slightly larger font size than "scientific".

USA: One Gateway Center, Suite 415 New 1-617-527-9933. Ext. 22 Fax: 1-617-5

L: van Rensselaerweg 4. Spankeren 6 Fax:[phone]

# 510(k) Summary

## Coaqulation Control Level 1, 2, 3

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 510K number is: _ h022040

- Vital Scientific NV Applicant: One Gateway Center, Suite 415 Newton, MA 02158 Phone: [phone] x41 Fax: [phone]
Israel M. Stein MD Contact:

Date: June 18, 2002

#### Device Name:

Coagulation Control Level 1, 2, 3 (Coaqulation Control Plasma). The Coagulation Control is also tradenamed the Vital Scientific Coagulation Control, and Quikcoag Coagulation Control. References in this document submission may use any of these names interchangeably.

#### Common Name:

Coagulation Control Plasma

#### Classification Name:

Coagulation Control Plasma has been classified as Class II device, 21 CFR 864.5425 (Product Code GGN). This device is intended for clinical use as a

{1}------------------------------------------------

control to monitor coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT).

### Description of the Coagulation Control

The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.

#### Intended Use

The Coagulation Controls Levels 1, 2, and 3 are intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 vields results in the moderately abnormal range. Level 3 is intended to vield results in the extremely abnormal range.

#### Labeling:

This device is labeled in accordance with 21 CFR 801.

## Substantial Equivalence:

The Coagulation Control Level 1 was compared to Precision Biologic Pooled Normal Plasma (K952662). The Coagulation Control 2 was compared with the Assess Low Abnormal Control from Instrumentation laboratory (K931117). The Coagulation Control 3 was compared with the Assess High Abnormal Control from Instrumentation Laboratory (K931118) on the MLA-900C Coagulometer (K884863).

Within-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 1 and 2 below.

| Control Level | PT Vital Controls<br>Average ± %CV, n = 20 | PT Reference Controls<br>Average ± %CV, n = 20 |
|-------------------------|--------------------------------------------|------------------------------------------------|
| Level 1 (Normal) | 12.0 ± 1.1% | 11.6 ± 0.7% |
| Level 2 (Low abnormal) | 18.8 ± 1.4% | 18.7 ± 1.2% |
| Level 3 (High abnormal) | 32.6 ± 3.5% | 32.6 ± 2.7% |

Table 1: Within-run Precision Results using PT Reagents

{2}------------------------------------------------

Page 3

# Table 2: Within-run Precision Results using APTT Reagents

| Control Level | APTT values of Vital Controls<br>Average ± %CV, n = 20 | APTT values of Reference Controls<br>Average ± %CV, n = 20 |
|-------------------------|--------------------------------------------------------|------------------------------------------------------------|
| Level 1 (Normal) | 28.5 ± 2.3% | 24.9 ± 2.3% |
| Level 2 (Low abnormal) | 47.0 ± 1.7% | 54.8 ± 2.2% |
| Level 3 (High abnormal) | 61.2 ± 1.9% | 95.7 ± 2.3% |

Between-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 3 and 4.

Table 3: Day to Day Precision Results using PT Reagent

| Day | PT values of Vital Controls<br>Average ± %CV | | | PT values of Reference Controls<br>Average ± %CV | | |
|--------------------------|----------------------------------------------|---------|---------|--------------------------------------------------|--------------|------------------|
| | Level 1 | Level 2 | Level 3 | Normal | Low Abnormal | High<br>Abnormal |
| Average<br>(all days) | 11.9 | 18.3 | 31.8 | 11.5 | 18.3 | 31.6 |
| %CV<br>(between<br>days) | 1.5% | 3.5% | 4.5% | 1.2% | 2.0% | 3.3% |

Table 4: Day to Day Precision Results using APTT Reagent

| Day | APTT values of Vital Controls<br>Average ± %CV | | | APTT values of Reference Controls<br>Average ± %CV | | |
|--------------------------|------------------------------------------------|---------|---------|----------------------------------------------------|--------------|------------------|
| | Level 1 | Level 2 | Level 3 | Normal | Low Abnormal | High<br>Abnormal |
| Average<br>(all days) | 28.5 | 46.7 | 61.8 | 25.0 | 54.5 | 94.1 |
| %CV<br>(between<br>days) | 1.8% | 0.7% | 3.9% | 0.5% | 2.0% | 2.7% |

Vital Scientific concludes that the Coagulation Controls Levels 1,2, and 3 have a similar intended use, technological characteristics and performance data which

{3}------------------------------------------------

support the statement that the Coagulation Controls Levels 1,2, and 3 are substantially equivalent to the predicate devices.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 2 3 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# Israel M. Stein, MD Managing Director US Branch OfficeVital Scientific One Gateway Center Suite 415

k022046 Re:

Newton, MA 02158

Trade/Device Name: Coagulation Control Levels 1, 2, and 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: June 21, 2002 Received: June 24, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 -

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/cdrb/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

{6}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K O2 30 40 40 ______________________________________________________________________________________________________________________________________

Device Name: Coagulation Control Levels 1, 2, and 3

Indications For Use:

(Per 21-CFR-801.109)

The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign (Off) 02204 Division of Clinical Laboratory Devices 510(k) Number -Prescription Use Over-The-Counter Use

OR

(Optional Format 1-2-96)