CALIBRATION PLASMA LMW HEPARIN

K030964 · Instrumentation Laboratory CO · JIS · Jun 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030964
• Device Name: CALIBRATION PLASMA LMW HEPARIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JIS · Clinical Chemistry
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

Device Story

Calibration Plasma LMW Heparin functions as a tri-level calibrator for chromogenic heparin assays. It is used in clinical laboratory settings to establish calibration curves on Instrumentation Laboratory (IL) analyzer systems. By providing known reference values, it enables the quantification of heparin levels in patient samples, assisting clinicians in monitoring anticoagulant therapy. The device is intended for professional use by laboratory personnel.

Clinical Evidence

Bench testing only. A precision study was conducted over multiple days with multiple runs (n=60) using IL reagents and instrumentation. Results showed total %CV ranging from 2.58% to 4.24% across three levels of the calibrator.

Technological Characteristics

Tri-level plasma-based calibrator for chromogenic heparin assays. Designed for use with IL instrumentation. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a tri-level calibrator to prepare calibration curves for chromogenic heparin assays in an in vitro diagnostic setting.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Assess Calibration Plasma (K002400)

Submission Summary (Full Text)

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K030964

## Section 3 Calibration 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 devices:

Calibration Plasma LMW Heparin

#### Classification names:

| Common Name | Primary Calibrator |
|-------------------|--------------------|
| Product Code | JIS |
| Regulation Number | 862.1150 |
| Classification | Class II |

### Identification of predicate devices:

K002400 Assess Calibration Plasma

This calibration plasma 510(k) cleared as part of analyzer systems, NOTE: most recently the ACL Advance.

### Description of the device/intended uses:

Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

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

The new Calibration Plasma LMW Heparin is substantially equivalent in intended use and performance with heparin assays to the predicate calibrator: Assess Calibration Plasma.

#### Summary of Performance Data:

A precision study was performed with Calibration Plasma LMW Heparin (tri-level) 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 |
|-------------|---------------|-------------------|--------------------|--------------|
| Level 1 | -0.03 | 0.018 (SD) | 0.008 (SD) | 0.024 (SD) |
| Level 2 | 0.47 | 2.99 | 1.47 | 4.24 |
| Level 3 | 0.80 | 2.21 | 0.00 | 2.58 |

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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 and Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH • HUMAN SERVICES • USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: k030964

> Trade/Device Name: Calibration Plasma LMW Heparin Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS, 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.

JUN - 6 2003

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 Putman

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): ____________________________________________________________________________________________________________________________________________________

Calibration Plasma LMW Heparin Device Name:

Indications for Use:

Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Division Sign-Off</i> |
|--|--------------------------|
| | |

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K030964 |
|------------------------------------------|-------------------------|
| Prescription Use<br>(Per 21 CFR 801.019) | OR Over-The-Counter Use |

Section 2

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