DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS

K042941 · Dade Behring, Inc. · GIZ · Dec 2, 2004 · Hematology

Device Facts

• Record ID: K042941
• Device Name: DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
• Applicant: Dade Behring, Inc.
• Product Code: GIZ · Hematology
• Decision Date: Dec 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

Device Story

Lyophilized calibrator and quality control materials derived from citrated human plasma and porcine-sourced unfractionated heparin; used to calibrate and monitor performance of Berichrom® Heparin assay on photo-optical coagulation analyzers; provides reference values for heparin measurement; assists laboratory personnel in ensuring assay accuracy and quality control; supports clinical monitoring of heparin therapy.

Clinical Evidence

Bench testing only. Traceability established using USP Heparin Sodium Reference Standard. Method comparison performed on Dade Behring BCS® and Sysmex® CA-1500 analyzers showed high correlation (r=0.9985 and r=0.9996 respectively) against USP standard-spiked plasma samples. Reconstitution stability confirmed for 8 hours at 2-8°C.

Technological Characteristics

Lyophilized product; citrated human plasma base; porcine-sourced unfractionated heparin. Used as an accessory for coagulation analyzers. No electronic or software components.

Indications for Use

Indicated for use as a calibrator and quality control material for the Berichrom® Heparin assay to measure unfractionated heparin in human plasma samples.

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

• aca® Heparin Calibrator (K843202)
• Ci-Trol® Heparin Controls, Low and High (K812424)

Submission Summary (Full Text)

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K04294/

1.

DEC - 2 2004

# 510(k) Summary Heparin Calibrator and Controls Manufacturer's Name, Address, Telephone, and Contact Person,

Date of Preparation: Dade Behring Inc. Manufacturer: P.O. Box 6101

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714 Attn: Radames Riesgo Tel: [phone]

October 22, 2004 Preparation date:

#### 2. Device Name/ Classification:

Dade Behring Heparin Calibrator and Controls / Multipurpose system for in vitro coagulation studies, Class II (864.5425)

Newark, Delaware 19714

#### 3. Identification of the Legally Marketed Device:

aca® Heparin Calibrator (K843202)

Ci-Trol® Heparin Controls, Low and High (K812424)

#### 4. Device Description:

Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.

#### 5. Device Intended Use:

The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

### 6. Medical device to which equivalence is claimed and comparison information:

The Heparin Calibrator is substantially equivalent in intended use to Dade Behring aca® Heparin Calibrator, Level 3 (K843202). The Controls are substantially equivalent to Dade Behring Ci-trol® Heparin Controls, Low and High (K812424).

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#### 7. Device Performance Characteristics:

Using at least duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values when stored for eight (8) hours at 2 to 8°C.

Different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples and the heparin recovery evaluated using a calibration curve established using the USP Heparin Sodium Reference Standard. The same samples were then measured using a calibration curve established with the new Heparin calibrator. Results were compared using regression analysis and the following statistics were obtained:

| Dade Behring BCS® Analyzer: | $Y = 1.07 X - 0.01, r = 0.9985$ |
|-----------------------------|---------------------------------|
| Sysmex® CA-1500 Analyzer: | $Y = 0.97 X + 0.01, r = 0.9996$ |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

DEC - 2 2004

k042941 Re:

Trade/Device Name: Dade Behring Heparin Calibrator and Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GIZ Dated: October 22, 2004 Received: October 25, 2004

Dear Mr. Riesgo:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

Dade Behring Heparin Calibrator and Controls Device Name:

Indications for Use:

Prescription Use

(Part 21 CFR 801 Subpart D)

The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

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AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801)

510(k) K042941