MSC LIPID CONTROL

K103271 · Maine Standards Co. · JJY · Jan 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103271
• Device Name: MSC LIPID CONTROL
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo AI), and Apolipoprotein B (Apo B), on the instruments listed in the value sheet.

Device Story

MSC Lipid Control is a human serum-based liquid quality control material. It contains stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B. Used in clinical laboratories to monitor the ongoing precision of analytical instruments. The control is processed alongside patient samples; healthcare providers compare the measured values against the provided value sheet to verify instrument performance and ensure accurate clinical decision-making. Material of human origin is tested at the donor level using FDA-approved methods.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Human serum-based liquid quality control material. Contains stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of clinical laboratory systems for HDL-C, LDL-C, Total Cholesterol, Triglycerides, Apo AI, and Apo B. Intended for professional clinical laboratory use.

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.

Predicate Devices

• Bio-Rad Liquichek™ Lipids Control Level 1 and 2 (K012513)
• MSC Lipid Control (without Apo Al and Apo B) (K082067)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company, LLC. The word "maine" is on the top left, with a horizontal line underneath it. A diagonal line goes from the top right to the bottom left, and the word "standards" is on the bottom right. The words "COMPANY LLC" are underneath the word "standards" in a smaller font.

JAN 2 5 2011

# 510(k) SUMMARY

«This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: k103271."

| Submitter: | Maine Standards Company |
|------------|-------------------------------|
| Address: | 765 Roosevelt Trail |
| | Windham, ME 04062 |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Holly A. Cressman, Mgr. QA/RA |

Summary prepared on: October 29, 2010

| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|-----------------------------|-----------------------------------------------------------|
| Device description: | Quality control material (assayed and unassayed) |
| Proprietary Name: | MSC Lipid Control |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| - Regulatory Class: | Class I |

### Predicate Device:

Bio-Rad Liquichek™ Lipids Control Level 1 and 2 (K012513). MSC Lipid Control (without Apo Al and Apo B) (K082067)

#### Device description:

The MSC Lipid Control is a human serum based liquid quality control containing stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B of human origin.

Material of human origin used in the manufacture of this MSC Lipid Control kit was tested at the donor level using FDA approved methods.

#### Intended use:

The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo Al), and Apolipoprotein B (Apo B), on the instruments listed in the value sheet.

## Summary:

The information provided in this pre-market notification demonstrates that the performance of MSC Lipid Control is substantially equivalent in form and function to the predicate devices for its stated intended use.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Maine Standards Company c/o Holly Cressman, Manager, QA/RA 765 Roosevelt Trail Windham, ME 04062

JAN 2 5 Eutl

Re: k103271/S001 Trade Name: MSC Lipid Control Regulation Number: 21 CFR \$862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: December 21, 2010 Received: December 29, 2010

Dear Ms. Cressman:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. 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: _k103271

Device Name: MSC Lipid Control

Indications for Use:

The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo AI), and Apolipoprotein B (Apo B), on instruments listed in the value sheet.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k103271

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