HEPARIN CONTROL PLASMA LEVEL 2

K992279 · Pacific Hemostasis · GGN · Aug 26, 1999 · Hematology

Device Facts

• Record ID: K992279
• Device Name: HEPARIN CONTROL PLASMA LEVEL 2
• Applicant: Pacific Hemostasis
• Product Code: GGN · Hematology
• Decision Date: Aug 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Device Story

Pacific Hemostasis Heparin Control Plasma Level 2 is a lyophilized, citrated plasma preparation derived from healthy human donors. It contains sodium heparin, stabilizers, and buffers. The device serves as an unassayed control for clinical laboratory heparin assay procedures and APTT testing. It is used by laboratory professionals to verify the accuracy and precision of coagulation testing systems. By providing a sample with known moderately high abnormal APTT values, it allows clinicians to validate the performance of their testing equipment, ensuring reliable monitoring of heparin therapy. The device is non-reactive for HBsAg and negative for HIV and HCV antibodies.

Clinical Evidence

Bench testing only. Precision studies compared the subject device to the predicate. Between-run precision for APTT testing yielded a CV of <3.0%; within-run precision yielded a CV of <2.0%. No clinical patient data was required or presented.

Technological Characteristics

Lyophilized citrated plasma; contains sodium heparin, stabilizers, and buffers. Form factor is a reagent for in vitro diagnostic use. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as a quality control material in heparin assay procedures and monitoring heparin therapy via Activated Partial Thromboplastin Time (APTT) testing in patients requiring such monitoring.

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

• Dade Ci-Trol Heparin Control High (K771346)

Submission Summary (Full Text)

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K992279

510(k) Summar Heparin Control Plasma, Level 2

#### PREMARKET NOTIFICATION 510(k) SUMMARY 7.0

| Applicant: | Laura A. Worfolk, Ph.D. |
|----------------------|----------------------------------------------------------------------|
| Address: | Pacific Hemostasis<br>11515 Vanstory Drive<br>Huntersville, NC 28078 |
| Phone: | [phone] or [phone] |
| Fax: | [phone] |
| Contact Person: | Same as above. |
| Date: | July 6, 1999 |
| Trade Name: | Heparin Control Plasma Level 2 |
| Common Name: | Heparin Control Plasma Level 2 |
| Classification Name: | Plasma, Coagulation Control |
| Equivalent Device: | Dade Ci-Trol Heparin Control High, K771346 |

## Description of Heparin Control Level 2

Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

### Intended Use of Heparin Control Level 2

Pacific Hemostasis Heparin Control Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

#### Summary of Performance Data for Substantial Equivalence Comparisons

Between-run and within-run precision studies yielded equivalent data for Pacific Hemostasis and Dade Brand Coagulation Heparin control plasmas. For both controls a CV of less than 3.0% was obtained for APTT between-run testing, and less than 2.0% for within-run testing.

Based on the data provided, the similar composition and intended use, it is our conclusion that these two products are substantially equivalent.

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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 26 1990

Laura A. Worfolk, Ph.D. Research Scientist Pacific Hemostasis 11515 Vanstory Drive Suite 125 Huntersville, North Carolina 28078-8144

K992279 Re: Trade Name: Heparin Control Plasma Level 2 Regulatory Class: II Product Code: GGN Dated: August 9, 1999 Received: August 11, 1999

Dear Dr. Worfolk:

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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 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). 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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/dsma/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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# STATEMENT OF INDICATIONS FOR USE

Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use as a control in heparin assay procedures.

Peter E. Madsen

Prescription
Use

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