PURPLE/BLACK HEPARIN ASSAY CONTROL

K042206 · Medtronic Vascular · GGN · Oct 18, 2004 · Hematology

Device Facts

• Record ID: K042206
• Device Name: PURPLE/BLACK HEPARIN ASSAY CONTROL
• Applicant: Medtronic Vascular
• Product Code: GGN · Hematology
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

To verify the performance of the HMS instrument and HMS Heparin Assay cartridges

Device Story

Purple/Black Heparin Assay Control is an in vitro diagnostic control used to verify performance of HMS (Hemostasis Management System) instruments and associated Purple/Black HMS Heparin Assay cartridges. Device serves as quality control material to ensure system accuracy during heparin monitoring. Operated by clinical laboratory personnel or healthcare providers in clinical settings. Output is a verification of instrument/cartridge performance, ensuring reliability of heparin assay results used for clinical decision-making regarding anticoagulation therapy.

Clinical Evidence

Bench testing only. Verification testing performed on three control lots in Channels 5/6 of HMS cartridges (N=50). All lots met acceptance criteria of < 249 seconds.

Technological Characteristics

Quality control reagent containing USP porcine heparin. Used with Medtronic HMS cartridges. Verification testing conducted per ISO 14971 risk management standards and 21 CFR Part 820 quality system regulations.

Indications for Use

Indicated for verifying the performance of the HMS instrument and HMS Heparin Assay cartridges.

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

• Purple/Black HMS Control (K922031)

Submission Summary (Full Text)

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OCT 1 8 2004

K042206

### 510(k) Summary

| Date Prepared: | August 13, 2004 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Dawn M. Stenstrom<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

# Device Name and Classification:

| Trade Name: | Purple/Black Heparin Assay Control |
|--------------------|------------------------------------|
| Common Name: | Analyzer, Heparin, Automated |
| Classification: | Class II |
| Predicate Devices: | Purple/Black HMS Control, K922031 |

Hepcon® HMS Coagulation System and its Associated Cartridges and Controls, K894317

#### Device Description

The Purple/Black Heparin Assay control is an in vitro diagnostic device. This control is intended to verify the performance of the HMS instrument and the Purple/Black HMS Heparin Assay cartridge. The cartridge is for use in the HMS Plus (Hemostasis Management System) instrument.

#### Indication for Use

This product is intended to verify the performance of the HMS instrument and HMS Heparin Assay cartridges.

# Comparison to Predicate Device

The predicate devices are the currently marketed Purple/Black HMS control and the other colored HMS controls. The currently marketed Purple/Black control has the same indications for use and is the same in all aspects to the modified control with exception of the source of heparin.

## Summary of Performance Data

Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.

## Conclusion

Medtronic has demonstrated that the Purple/Black Heparin Assay control is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Dawn M. Stenstrom Principal Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

OCT 1 8 2004

k042206 Re:

Trade/Device Name: Purple/Black Heparin Assay Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN, JOX, GFT Dated: September 28, 2004 Received: September 29, 2004

Dear Ms. Stenstrom:

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 for associated in the encreatment 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 he 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 nredicate 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, of to If you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the VITO Diagnostic Dovice Draiaaten and manager and premarket notification" (21CFR Part 807.97). regulation entitled, "Misolanding by reiseous on your responsibilities under the Act from the You may outlif only 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

4042206 510(k) Number (if known):

Device Name:

# Purple/Black Heparin Assay Control

Indications for Use:

To verify the performance of the HMS instrument and HMS Heparin Assay cartridges

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arzeline Bautista

Division Sign-Off

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) KD42206