CONTROL PLASMA LMW HEPARIN

K030965 · Instrumentation Laboratory CO · GGN · Jun 6, 2003 · Hematology

Device Facts

• Record ID: K030965
• Device Name: CONTROL PLASMA LMW HEPARIN
• Applicant: Instrumentation Laboratory CO
• Product Code: GGN · Hematology
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.

Device Story

Control Plasma LMW Heparin is an in vitro diagnostic quality control material used to verify the performance of chromogenic heparin assays. It provides known low and high heparin levels to assess the precision and accuracy of laboratory instrumentation. It is intended for professional use in clinical laboratory settings. By running these controls alongside patient samples, clinicians can ensure the reliability of heparin assay results, which are critical for monitoring anticoagulant therapy.

Clinical Evidence

Bench testing only. A precision study was conducted over multiple days with multiple runs (n=60) using IL reagents and instrumentation. Results for Low Level (0.42 IU/mL) showed 3.81% within-run CV, 1.70% between-run CV, and 4.65% total CV. Results for High Level (0.75 IU/mL) showed 2.26% within-run CV, 0.71% between-run CV, and 3.34% total CV.

Technological Characteristics

In vitro diagnostic quality control material; liquid plasma-based; designed for use with chromogenic heparin assays on automated coagulation analyzers. No specific materials of construction or software algorithms are described.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material for chromogenic heparin assays to monitor precision and accuracy at low and high heparin levels.

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

• Assess Low and High Heparin Controls (K002400)

Submission Summary (Full Text)

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K030965

# Section 3 Control Plasma LMW Heparin - 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax:

### Contact Person:

Carol Marble, Regulatory Affairs Director Phone: [phone] / Fax: [phone]

### Summary Prepared:

March 26, 2003

### Name of the device:

Control Plasma LMW Heparin

### Classification names:

| Common Name | Plasma, Coagulation Control |
|-------------------|-----------------------------|
| Product Code | GGN |
| Regulation Number | 864.5425 |
| Classification | Class II |

# Identification of predicate devices:

K002400 Assess Low and High Heparin Controls NOTE: These control levels were 510(k) cleared as part of analyzer systems. most recently the ACL Advance.

# Description of the device/intended uses:

Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.

#### Statement of Technological Characteristics of the Device Compared to Predicate Devices:

Control Plasma LMW Heparin is substantially equivalent in intended use to the predicate controls: Assess Low and High Heparin Controls.

# Summary of Performance Data:

A precision study was performed with Control Plasma LMW Heparin (Low and High Levels) over multiple days with multiple runs (n=60) using specific lots of IL reagents on IL instrumentation:

| Description | Mean<br>IU/mL | Within Run<br>%CV | Between Run<br>%CV | Total<br>CV% |
|-------------|---------------|-------------------|--------------------|--------------|
| Low Level | 0.42 | 3.81 | 1.70 | 4.65 |
| High Level | 0.75 | 2.26 | 0.71 | 3.34 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, each slightly offset from the other. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 2003

Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: k030965

Ms. Carol Marble

Trade/Device Name: Control Plasma LMW Heparin Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGN, KFF Dated: May 19, 2003 Received: May 30, 2003

Dear Ms. Marble:

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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Control Plasma LMW Heparin

Indications for Use:

Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division/Sign-Off | |

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K030965 |
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| Prescription Use<br>(Per 21 CFR 801.019) | <div> <img alt="Checkmark" src=""/> </div> | OR | Over-The-Counter Use | |
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