COAGULATION FACTOR V DEFICIENT PLASMA

K981709 · Dade Behring, Inc. · GJT · Oct 13, 1998 · Hematology

Device Facts

• Record ID: K981709
• Device Name: COAGULATION FACTOR V DEFICIENT PLASMA
• Applicant: Dade Behring, Inc.
• Product Code: GJT · Hematology
• Decision Date: Oct 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

In vitro diagnostic reagent for the determination of the activity of coagulation factor V and for the detection of Factor V Leiden in citrated human plasma when used in conjunction with the Dade Behring ProC APC Method.

Device Story

Coagulation Factor V Deficient Plasma is a lyophilized human plasma reagent used in clinical laboratories to determine Factor V activity and detect Factor V Leiden mutation. It contains <1% residual Factor V activity and >40% of other coagulation factors, plus a heparin antagonist. The reagent is used in conjunction with the Dade Behring ProC APC assay on a coagulation timer. By measuring clotting times in patient plasma samples, the device enables the identification of Factor V Leiden mutations. This diagnostic information assists clinicians in diagnosing congenital or acquired Factor V deficiency states and assessing thrombotic risk.

Clinical Evidence

Study of 300 patient samples (88 Factor V Leiden positive, 212 healthy donors). Subject device with Dade Behring ProC APC assay demonstrated 99% sensitivity and 100% specificity for Factor V Leiden. Reproducibility study on Behring Coagulation Timer (n=8 replicates/day over 5 days) showed 2.3% CV for normal samples and 4.9% CV for pathological samples, consistent with NCCLS EP5 guidelines.

Technological Characteristics

Lyophilized human plasma; residual Factor V activity ≤1%; other coagulation factors >40%; contains heparin antagonist. Used with automated coagulation timer. In vitro diagnostic reagent.

Indications for Use

Indicated for the determination of coagulation factor V activity and detection of Factor V Leiden mutation in citrated human plasma for patients suspected of congenital or acquired Factor V deficiency states.

Predicate Devices

• Chromogenix V-Def Plasma

Reference Devices

• Coatest APC Resistance VS assay

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a date that appears to be written in black ink on a white background. The date is October 13, 1998. The letters and numbers are clearly legible. The date is written in a simple, straightforward style.

1981709

## Dade Behring

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.

Coagulation Factor V Deficient Plasma

## Summary of Safety and Effectiveness

Coagulation Factor V Deficient Plasma is a Class II device and has a classification name of coagulation factor deficient plasma (21 CFR 864.7290 ). It is intended as an in vitro reagent for the determination of the activity of coagulation factor V, as indicated for the diagnosis of congenital or acquired Factor V deficiency states. When used with the Dade Behring ProC APC assay, the factor V deficient plasma is suitable for detecting Factor V Leiden mutation.

Coagulation Factor V Deficient Plasma is a lyophilized human plasma with a residual Factor V activity of less than or equal to 1% and contains activities of the remaining coagulation factors of more than 40%. This composition is similar to the Chromogenix V-Def Plasma, the predicate device, which consists of lyophilized human plasma deficient in Factor V. In addition, both deficient plasmas contain a heparin antagonist. When both reagents are used with an appropriate APC Resistance assay, highly sensitive determination of the Factor V Leiden mutation is possible.

Comparative Analysis: In a study of 300 patient samples (88 Factor V Leiden + 212 healthy blood donors), Coagulation Factor V Deficient Plasma used with the Dade Behring ProC APC assay yielded a specificity of 100% and a sensitivity of 99% for Factor V Leiden. In comparison, the Coatest APC Resistance VS assay (used with the V-Def Plasma) vielded a specificity of 99% and a sensitivity of 100% for Factor V Leiden.

Precision: A reproducibility study for Factor V was run on the Behring Coagulation Timer with samples in both normal and pathological ranges. Samples were run over a five day period with one run per day in replicates of eight. Precision data were calculated in a manner consistent with NCCLS Guideline EP5. The reproducibility study resulted in a 2.3% CV for the normal sample and 4.9% CV for the pathological sample.

Dade Behring considers the Coagulation Factor V Deficient Plasma to be substantially equivalent to the Chromogenix V-Def Plasma in terms of intended use, reagent composition and overall performance characteristics. When used with the Dade Behring ProC APC assay, sensitive determination of Factor V Leiden is possible.

Carolyn K. George

Carolyn K. George Manager, Regulatory Affairs, Biology

September 15, 1998

---

Date

510K
Summer
(Revis.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 3 1998

Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re : K981709 Coagulation Factor V Deficient Plasma Requlatory Class: II Product Code: GJT September 15, 1998 Dated: Received: September 16, 1998

Dear Ms. George:

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 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.

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

Page 2

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 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 Ditman

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 ……………

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

## Indications Statement

Ravi
Ind.
Use

Device Name: Dade Behring Coagulation Factor V Deficient Plasma

Indications for Use: In vitro diagnostic reagent for the determination of the activity of coagulation factor V and for the detection of Factor V Leiden in citrated human plasma when used in conjunction with the Dade Behring ProC APC Method.

Carly K. George

Carolyn K. George Manger, Regulatory Affairs

September 15, 1998
Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Petul. Mauri.

Division of Clinical Laboratory Devices
510(k) Number K981709

510(k) Number

Division Sign-Off Office of Device Evaluation

prescription use