VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

K090475 · Maine Standards Co. · JJY · Apr 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090475
• Device Name: VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE CM2 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, semi-automated, and manual chemistry systems. Each VALIDATE CM2 Calibration Verification/Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-I, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

Device Story

VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of human serum-based solutions containing multiple levels of analytes (TnI, TnT, BNP, NT-proBNP, hsCRP, MPO). Used in clinical laboratories by trained professionals to verify the performance of automated, semi-automated, and manual chemistry analyzers. Device establishes relationship between theoretical operation and actual performance of analytes; confirms linearity and reportable ranges. Not for routine quality control or calibration. Healthcare providers use output to validate analyzer accuracy and ensure reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Value assignment process involves triplicate assays of high/low levels and final bottled product to ensure linear relationship.

Technological Characteristics

Human serum-based matrix; liquid, ready-to-use form factor. Multi-level test set (2 sets of 6 levels). Storage at -10 to -20°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for in vitro diagnostic use in clinical chemistry systems to verify linearity, calibration, and reportable ranges for Troponin-I, Troponin-T, BNP, NT-proBNP, hsCRP, and MPO. Not for use as routine quality control or calibration materials. Not for use on systems employing reflectance spectroscopy.

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® CM1 Calibration Verification / Linearity Test Set (K090475)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The logo consists of the word "maine" above a horizontal line that is intersected by a diagonal line. Below the horizontal line is the word "standards" and below that is the word "COMPANY" in smaller letters.

## 510(k) SUMMARY

APR 1 6 2009

"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: k 090475."

Submitter: Maine Standards Company Address: 765 Roosevelt Trail Windham, ME 04062 Telephone: [phone] Fax: [phone] Contact:

Summary prepared on: February 23, 2009

| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|-----------------------------|----------------------------------------------------------------|
| Device description: | Quality control material (assayed and unassayed)* |
| Proprietary Name: | VALIDATE® CM2 Calibration Verification / Linearity Test<br>Set |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJY* |

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

Regulatory Class: Class I

#### Predicate Device:

VALIDATE® CM1 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME.

Device description: VALIDATE® CM2 Calibration / Linearity Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.

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Intended use: The VALIDATE® CM2 Calibration Verification / Linearity Test Sets are used by trained laboratory professionals for quantitatively verifying calibrating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert. These materials are not intended for use as routine quality control materials or as calibration materials.

### Comparison of VALIDATE® CM2 Calibration Verification / Linearity Test Set to the predicate device:

Table 1 compares characteristics of the VALIDATE® CM2 Calibration Verification / Linearity Test Set with those of the VALIDATE® CM1 Calibration Verification / Linearity Test Set.

| | VALIDATE®<br>CM1 | VALIDATE®<br>CM2 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 401 | 402 |
| Intended<br>Use | For in vitro diagnostic use<br>in quantitatively verifying<br>calibration, validating<br>reportable ranges, and<br>determining linearity in<br>automated, semi-<br>automated and manual<br>chemistry analyzers. | For in vitro diagnostic use<br>in quantitatively verifying<br>calibration, validating<br>reportable ranges, and<br>determining linearity in<br>automated, semi-<br>automated and manual<br>chemistry analyzers. |
| Analytes | CK-MB, MYO | Tnl, TnT, BNP, NT-<br>proBNP,hsCRP,MPO |
| Matrix | Human Serum | Human Serum |
| Number of<br>Levels | 5 | 2 sets of 6 including base<br>matrix |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 5 x 3.0mL | 12 x 2.0 mL |
| Stability | Until expiration | Until expiration |
| Storage | -10 to -20°C | -10 to -20°C |

### TABLE 1 - Comparison of Devices

The performance of VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions on the Beckman Access II (Tnl, BNP), the Beckman Immage 800 (hsCRP), the Beckman Synchron DxC with Diazyme reagent (MPO), the Roche e411 (TNT, NTproBNP), and the Roche Integra 400+ (hsCRP) has been shown to be substantially equivalent using pre-production lots of VALIDATE® CM2 Calibration Verification / Linearity Test Sets to the VALIDATE® CM1 Calibration Test Set.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

APR ] 6 2009

k090475 Re:

Trade/Device Name: VALIDATE CM2 Calibration Verification/Linearity 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 23, 2009 Received: February 24, 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.

Corg 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

k090475 510(k) Number:

VALIDATE® CM2 Calibration Verification / Linearity Test Set Device Name:

Indications For Use:

VALIDATE® CM2 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, semi automated, and manual chemistry systems. Each VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-1, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

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)

Lucy Phillips
Division City Off

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 199 0475

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