VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

K083891 · Maine Standards Co. · JJY · Mar 23, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083891
• Device Name: VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.

Device Story

VALIDATE® THY Calibration Verification Test Set is a human serum-based quality control material; used to establish relationship between theoretical operation and actual performance of clinical chemistry analyzers. Device consists of two sets: THY set (T3, T4, TSH, cortisol) and FT4 set (Free T4); each provided in five levels with a linear relationship between levels. Used in clinical laboratories by technicians or laboratory staff to verify reportable ranges and calibration of chemistry systems. Output is a set of known-concentration samples; healthcare providers compare measured values against expected values to ensure system accuracy and linearity. Benefits include improved confidence in patient test results and identification of potential system drift or calibration errors.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Traceability to NIST SRM or primary analytical standards is maintained.

Technological Characteristics

Human serum-based matrix; five-level concentration design; liquid form factor. Designed for use in automated, semi-automated, and manual chemistry systems. No specific materials or software algorithms described.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of T3, T4, TSH, cortisol, and Free T4 assays in automated, semi-automated, and manual chemistry systems.

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® Thyroid Calibration Verification/Linearity Test Set (k062501)

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 logo is divided by a diagonal line, with "maine" above the line and "standards" below. The words "COMPANY LLC" are written in smaller letters below "standards".

MAR 2 3 2009

## 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: (K083891"."

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

December 19, 2008 Summary prepared on:

| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|-----------------------------|-----------------------------------------------------------|
| Device description: | Quality control material (assayed and un-assayed) |
| Proprietary Name: | VALIDATE® THY Calibration Verification Test Set |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| Regulatory Class: | Class I |

### Predicate Device:

VALIDATE Calibration Verification Test Set (K062501), Maine Standards Company Windham, Maine

Device description: VALIDATE®THY Calibration Verification Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through 5.

Intended use; Each VALIDATE® THY-Galibration / Linearity Test Set consists / of two sets of bottles, a THY Set and a ET4 Set your set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.

VALIDATE® TH Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, and manual chemistry systems.

### Summary:

The information provided in this pre-market notification demonstrates that the performance of VALIDATE® THUCalibration Verification Test Sets is substantially equivalent in form and function to the predicate device for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 with its wings spread.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 2 3 2009

Maine Standards Company c/o Ms. Holly A Cressman Manager 765 Roosevelt Trail Windham, ME 04062

Re: k083891 Trade/Device Name: VALIDATE® THY Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: February 17, 2009 Received: February 17, 2009

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); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Cott C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Indications for Use

510(k) Number: K083891

VALIDATE® THY Calibration Verification Test Set Device Name:

Indications For Use:

Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.

VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.

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)

Signature of Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K083891

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