VON WILLEBRAND REAGENT

K972116 · Behring Diagnostics, Inc. · GGP · Jul 25, 1997 · Hematology

Device Facts

• Record ID: K972116
• Device Name: VON WILLEBRAND REAGENT
• Applicant: Behring Diagnostics, Inc.
• Product Code: GGP · Hematology
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

The Von Willebrand Reagent is intended for the determination of the ristocetin cofactor activity in human plasma.

Device Story

Von Willebrand Reagent consists of lyophilized platelets and ristocetin; used for in vitro diagnostic determination of ristocetin cofactor activity in human plasma. Device functions as a reagent kit for laboratory testing; provides quantitative measurement of cofactor activity. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing Von Willebrand's disease and other hemorrhagic diatheses, and in pre-operative screening. Benefits include standardized assessment of platelet-related clotting function.

Clinical Evidence

Comparative analysis performed on 70 normal and pathological human plasma samples against the predicate device. Results showed a correlation coefficient of 0.94, slope of 0.97, and y-intercept of -4.4. Precision studies conducted per NCCLS EP5 guidelines; within-run precision ranged from 6.1% to 16.2%, and total precision ranged from 7.6% to 16.9%.

Technological Characteristics

In vitro diagnostic reagent kit containing lyophilized platelets and ristocetin. Operates via ristocetin cofactor activity measurement. Intended for professional use in clinical laboratories.

Indications for Use

Indicated for the determination of ristocetin cofactor activity in human plasma to aid in the diagnosis of Von Willebrand's disease, diagnosis of diseases characterized by changes in ristocetin cofactor, and pre-operative screening of haemorrhagic diatheses.

Predicate Devices

• Helena Laboratories Ristocetin Cofactor Assay

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paul L. Rogers, Jr. Behring Diagnostics, Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, California as 161

K972116 Re: Von Willebrand Reagent Regulatory Class: II Product Code: GGP Dated: June 4, 1997 Received: June 5, 1997

Dear Mr. Rogers:

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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 Requlations.

Jul 2 5 1997

. . . .

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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 qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Aitman

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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BEHRING

L. Behring

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Von Willebrand Reagent

### 1. Manufacturer and Contact Information:

JUL 25 1997 972116

Behring Diagnostics GmbH Manufacturer: P.O. Box 1149 35001 Marburg, Germany

Paul Rogers Contact Information: Behring Diagnostics Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, CA 95161-9013 Tel: [phone]

## 2. Device Classification Name:

The Von Willebrand Reagent is a Class II device and has a classification name of Test, Qualitative and Quantitative Factor Deficiency.

#### 3. Intended Use:

The Von Willebrand Reagent is intended for the determination of the ristocetin cofactor activity in human plasma.

#### 4. Device Description and Characteristics:

The Von Willebrand Reagent consists of lyophilized platelets and ristocetin. This is similar to the Helena Laboratories Ristocetin Cofactor Assay (the predicate device) which consists of a lyophilized Platelet Reagent and a lyophilized Ristocetin Reagent.

A total of 70 patients (normal and pathological samples) were Comparative Analysis: tested with the Von Willebrand Reagent and compared with the predicate device. Regression analysis of the test results gave a correlation coefficient of 0.94, a slope of 0.97, and a yintercept of -4.4.

Precision: Precision studies were performed following the NCCLS EP5 guideline using normal and pathological plasma samples. The within-run precision ranged from 6.1% to 16.2%. The total precision ranged from 7.6 to 16.9%.

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પંચ Substantial Equivalence:

Behring Diagnostics Inc. considers Von Willebrand Reagent to be substantially equivalent to the Helena Laboratories Ristocetin Cofactor Assay in terms of intended use, reagent composition, and overall performance characteristics.

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510(k) Number (if known):

Von Willebrand Reagent Device Name:

Indications For Use:

Von Willebrand Reagent is used for the determination of ristocetin cofactor activity in human Volt Willebrand Reagent is of ristocetin cofactor activity is important in:

- The diagnosis of Von Willebrand's disease. .
- The diagnosis of diseases characterized by changes in the ristocetin cofactor. .
- Pre-operative screening of haemorrhagic diatheses. .

Concurrence of CDRH,

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

| Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|---------|
| | |
| (Division Sign-Off)<br>Division of Clinical Laboratory Device | |
| 510(k) Number | K972216 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Crunter Use __

(Opennal Format 1-2-96)

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