NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)

K040352 · Bioresource Technology, Inc. · JJY · Apr 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040352
• Device Name: NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
• Applicant: Bioresource Technology, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

NOVA-One Control is intended for use in the laboratory to monitor the accuracy and precision of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

Device Story

NOVA-ONE Lipid Control is a human-derived liquid quality control material; used in clinical laboratories to verify accuracy and precision of lipid analysis assays; functions as a reference material to monitor instrument performance and analytical stability; provides known values for constituents to allow comparison against laboratory results; assists healthcare providers in validating diagnostic test reliability; ensures consistent clinical decision-making by confirming assay performance.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via accelerated temperature studies (acceptance criterion ±15% of zero time value). Value assignment performed by assaying samples over three days with acceptance criteria of SD ≤15%.

Technological Characteristics

Liquid control material; human serum base with purified human proteins/chemicals. Two-level (Normal/Abnormal) form factor. Stability: 2 years at -20°C; 90 days unopened at 2-8°C; 30 days opened at 2-8°C. No electronic components or software.

Indications for Use

Indicated for laboratory use to monitor accuracy and precision of lipid constituent analysis. No specific patient population or contraindications described.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

APR - 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Alan Posner, Ph. D. Execute Vice President Bioresource Technology Inc. 1531 NW 65th Avenue Fort Lauderdale, FL 33313

k040352 Re: Trade/Device Name: NOVA- ONE Lipid Control Human Liquid Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 11, 2004 Received: February 12, 2004

Dear Dr. Posner:

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 vour 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 (OS) regulation (21 CFR Part 820).

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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.

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.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040352

Device Name: NOVA-ONE Lipid Control Human Liquid Lipid Control

Indications For Use:

NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

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 IF NEEDED)

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

Carol C Benson
Division Sign-Off

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Office of In Vitro Diagnostic
Device Evaluation and Safety

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