VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

K110880 · Maine Standards Company, LLC · JJY · Jul 5, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110880
• Device Name: VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
• Applicant: Maine Standards Company, LLC
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

Device Story

VALIDATE® GC3 is a quality control test kit containing purified chemicals in a human serum albumin base; used to verify linearity, calibration, and reportable range of automated, semi-automated, and manual chemistry systems. Kit consists of five levels of material with known concentrations to establish the relationship between theoretical and actual analyzer performance. Used by laboratory professionals in clinical settings. Output is a comparison of observed versus target values for specific enzymes, allowing clinicians to confirm instrument accuracy and reportable ranges. Benefits include ensuring reliable diagnostic results for patient testing.

Clinical Evidence

No clinical data. Bench testing only. Sponsor provided stability data for up to 8 months and value assignment data for Cholinesterase (CHE) across five levels, demonstrating target recovery within acceptable limits (max 8.0% difference).

Technological Characteristics

Matrix: Human serum albumin. Form: Liquid, ready-to-use. Levels: 5 levels. Analytes: ALP, ALT, AMY, AST, CK, GGT, LD, LIP, CHE. Storage: -10 to -25°C. Standard: NCCLS EP6-A.

Indications for Use

Indicated for in vitro diagnostic use to determine linearity, verify calibration, and verify reportable range for clinical laboratory testing of specified analytes.

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

• VALIDATE® GC3 Calibration Verification / Linearity Test Kit (k091225)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The word "maine" is on the top line, with a horizontal line underneath it. The word "standards" is on the second line, with the word "company" underneath it in smaller letters.

JUL - 5 201

## 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: 长川の母 8D

| Submitter: | Maine Standards Company |
|------------|------------------------------------------|
| Address: | 765 Roosevelt Trail<br>Windham, ME 04062 |

207-892-1300 Telephone: [phone] Fax:

Holly Cressman Contact:

Summary prepared on: March 23, 2011

Multi-Analyte Controls. All Kinds (Assayed and Unassayed) Device classification name: Device description: Quality control material (assaved and un-assayed)*

VALIDATE® GC3 Calibration Verification / Linearity Test Kit Proprietary Name:

Regulation Number: 21 CFR 862.1660

: : Product Code: JJY*

*Note: There is no FDA product code for calibration verification / linearity materials. Therefore, as with previous submissions by Maine Standards Company and other calibration / linearity manufacturers, JJY has been selected as the "best fit" FDA code for this product.

Regulatory Class: Class I

## Predicate Devices:

VALIDATE® GC3 Calibration Verification / Linearity Test Kit, Maine Standards Company, Windham, ME.

Device description: Each VALIDATE® GC 3 Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum albumin base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

Intended use: VALIDATE® GC3 Calibration Verification / Linearity Test Kits are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

{1}------------------------------------------------

## Summary:

The VALIDATE® GC3 Calibration Verification / Linearity Test Kits behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® GC3 Calibration Verification / Linearity Test Kits are as safe, as effective, and perform as well as or better than the predicate device.

:

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUL 0 5 2011

Maine Standards Company, LLC c/o Ms. Holly Cressman Manager Quality Assurance/Regulatory Affairs 765 Roosevelt Trail Windham, Maine 04062

Re: k110880

Trade Name: Validate ® GC3 Calibration Verification/Linearity Test Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class I, reserved Product Codes: JJY Dated: May 26, 2011 Received: June 01, 2011

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).

{3}------------------------------------------------

Page 2 -

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,

C.C.

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

{4}------------------------------------------------

## Indications for Use

KILO880 510(k) Number:

Device Name: VALIDATE® GC3 Calibration Verification / Linearity Test Kit

Indications For Use:

VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

Prescription Use × (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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) KIID 880

Page 1 of

2-1