VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901

K062501 · Maine Standards Co. · JJX · Sep 29, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062501
• Device Name: VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol. VALIDATE Thyroid Calibration Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.

Device Story

VALIDATE Thyroid Calibration Verification Test Set consists of six levels of human serum-based solutions containing T3, T4, human TSH, and Cortisol. Used in clinical chemistry laboratories to verify the linearity and reportable range of automated, semi-automated, or manual chemistry systems. Clinicians or laboratory technicians use the test set to compare theoretical values against actual system performance. This verification ensures the accuracy of patient diagnostic testing for thyroid function and cortisol levels.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Traceability to NIST Standard Reference Materials (SRM) or primary analytical standards was established.

Technological Characteristics

Human serum-based matrix; multi-level (6 levels) liquid test set; 3.0 mL per bottle. Designed for in vitro diagnostic use in chemistry systems. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use in clinical chemistry systems to verify linearity, calibration, and reportable ranges for T3, T4, TSH, and Cortisol. Prescription use only.

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

• Thyroid CAL●VER (k992034)

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 diagonally by a thick black line. The word "maine" is in the upper left corner, and the word "standards" is in the lower right corner. Below "standards" is the word "COMPANY LLC" in smaller letters.

SEP 2 9 2006

### 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: K062501."

| 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 |

August 16, 2006 Summary prepared on:

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

#### Predicate Device:

DOCUMENT Thyroid CAL VER (K992034), Microgenics Corp, Fremont, CA

Device description: VALIDATE Thyroid Calibration 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 six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. There exists a linear relationship among each set of solutions.

Intended use: The VALIDATE Thyroid Calibration Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol. VALIDATE Thyroid Calibration Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.

#### Summarv:

The information provided in this pre-market notification demonstrates that the performance of VALIDATE Thyroid Calibration 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

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Holly Cressman, OA/RA Manager Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062

EP 2 9 2006

Re: k062501

> Trade/Device Name: VALIDATE® Thyroid Calibration Verification Test Set Regulation Number. 21 CFR 862.1660 --Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 22, 2006 Received: August 25, 2006

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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#### Page 2 -

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/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Guticirez, 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 (if known): K 0 6 2 50 L

VALIDATE® Thyroid Calibration Verification Test Set Device Name:

Indications For Use:

VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.

**Prescription Use**
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Division Sign-Off

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Office of In Vitro Diagnostic Device
Evaluation and Safety
K062501