VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET

K091225 · Maine Standards Co. · JJY · Jun 25, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091225
• Device Name: VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the guantitative determination of linearity, calibration verification of reportable range in automated, semi automated, and manual chemistry systems. See attached 510k submission for the list of all analytes claimed.

Device Story

VALIDATE® GC1-GC4 Test Sets are human and aqueous-based quality control materials; used to establish relationship between theoretical operation and actual performance of chemistry analyzers. Device consists of multiple levels of solutions with linear relationships among them. Used in clinical laboratory settings by laboratory technicians/personnel to perform calibration verification and linearity checks. Output is a set of values compared against analyzer performance to ensure accuracy and reportable range validity. Benefits include ensuring clinical chemistry systems provide reliable patient results.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time, open bottle) and value assignment protocols were reviewed and found acceptable. Traceability to NIST SRM established for GC1, GC2, and GC4.

Technological Characteristics

Liquid, ready-to-use solutions. GC1, GC3, GC4: human serum matrix; GC2: aqueous matrix. 5 levels per set with linear relationship. Storage: -10 to -20°C (GC1, GC3, GC4) or 2-8°C (GC2). Value assignment via equal part dilutions per CLSI EP6-A.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to verify linearity, calibration, and reportable range of automated, semi-automated, and manual chemistry systems. No specific patient population or contraindications defined.

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® Chem 1 Calibration Verification / Linearity Test Set
• VALIDATE® Chem 2 Calibration / Linearity Test Set
• VALIDATE® Chem 3 Calibration Verification / Linearity Test Set
• VALIDATE® Chem 4 Calibration Verification / Linearity Test Set (K012120)
• VALIDATE® Chem 5 Calibration Verification / Linearity Test Set

Submission Summary (Full Text)

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

JUN 2 5 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: _ 09 1225

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

Summary prepared on: April 17, 2009

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

VALIDATE® GC1 Calibration Verification / Linearity Test Set Proprietary Name: VALIDATE® GC2 Calibration Verification / Linearity Test Set VALIDATE® GC3 Calibration Verification / Linearity Test Set VALIDATE® GC4 Calibration Verification / Linearity Test Set

| Regulation Number: | 21 CFR 862.1660 |
|--------------------|-------------------------------------------------|
| Product Code: | JJY* |
| | *Note: There is no FDA product code for colibra |

Note: There is no FDA product code for calibration verification / 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 |

### Predicate Devices:

VALIDATE® Chem 1 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. WHEIDATE® Chem 1 Calibration / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 3 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 4 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 5 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chilibration Verification / Linearity Test Set, Maine Standards Company, Windham, M.C.
VALIDATE® Collination Verification / Linearity Test Set, Maine Standards Co 77 Libration of Calibration Verification / Linearity Toot Oot, Maine Standards Company, Windham, ME.

**Note: The VALIDATE® CHEM 4 K012120 that was filed contained the following analytes: ALT, AST, CK, LD, ALP, AMY, GGT, LIP, TBIL, and DBIL. Later, the TBIL and DBIL analytes were split off into a stand alone product called VALIDATE® CHEM 5.

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Device description: VALIDATE® GC Calibration Verification / Linearity Test Sets are human and aqueous 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.

Intended use: Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the guantitative determination of linearity, calibration verification of reportable range in automated, semi automated, and manual chemistry systems. See attached 510k submission for the list of all analytes claimed.

#### Summary:

The VALIDATE® GC Calibration Verification / Linearity Test Sets 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 devices. VALIDATE® GC Calibration Verification / Linearity Test Sets are as safe, as effective, and perform as well as or better than the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 25 2009

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

Re: k091225

Trade/Device Name: VALIDATE GC1 Calibration Verification/Linearity Test Set, GC2 Calibration Verification/Linearity Test Set, GC3 Calibration Verification/Linearity Test Set and GC4 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: April 17, 2009 Received: April 27, 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 advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

G.C.H.

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

Enclosure

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# Indication for Use

510(k) Number (if known): 《○91乙乙5

Device Name:

VALIDATE® GC1 Calibration Verification / Linearity Test Set VALIDATE® GC2 Calibration Verification / Linearity Test Set VALIDATE® GC3 Calibration Verification / Linearity Test Set VALIDATE® GC4 Calibration Verification / Linearity Test Set

Indication For Use:

Validate® GC Calibration Verification / Linearity Test Sets 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. See attached Package Insert labeling for all analytes claimed.

Prescription Use X

And/Or

Over the Counter Use

(21 CFR Part 801 Subpart D)

(21 CFR Part 801

Subpart C)

(Please Do Not WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Dision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091225