VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS

K050504 · Maine Standards Co. · JJY · Mar 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050504
• Device Name: VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

Device Story

VALIDATE® Urine Chemistry Calibration Verification Test Sets consist of three kits (UC1, UC2, OSMO) containing multi-level liquid samples in human urine or serum matrix. Used by trained laboratory professionals in clinical chemistry settings to verify instrument calibration, reportable ranges, and linearity. Levels 1 and 5 are prepared to match instrument manufacturer's claimed linearity limits; intermediate levels (2, 3, 4) are created via admixture. Samples are assayed on clinical chemistry analyzers; recovered values are compared against expected tolerances to validate system performance. Benefits include ensuring accuracy and reliability of patient test results across the analytical measurement range.

Clinical Evidence

No clinical data. Bench testing only. Performance was validated by assaying levels 1 and 5 in triplicate on clinical chemistry analyzers to confirm they meet manufacturer-claimed linearity limits. Admixtures (levels 2, 3, 4) were subsequently tested in triplicate to verify recovery within required tolerances. Final in-process testing (FIPT) was performed in triplicate for all analytes in each level.

Technological Characteristics

Multi-level calibration verification material; human urine or serum-based matrix; liquid, ready-to-use form factor; stored at 2-8°C. Analytes include UA, ETOH, NA, K, CL, GLU, UUN, UTP, CA, MG, PHOS, CREAT, AMY, p-AMY, MA, and osmolality. No software or electronic components.

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual chemistry systems for specific urine and serum 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® Chemistry 1 Calibration Verification Test Set (k012117)
• Bio-Rad Liquichek™ Urine Chemistry Controls (k934357)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "maine/standards COMPANY LLC". The word "maine" is on the top line, with a line going through it. The word "standards" is on the second line, and the words "COMPANY LLC" are on the third line. There is also a stamp in the upper right corner that says "MAR 25 2005".

## 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: K o 505

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

Summary prepared on: February 18, 2005

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

#### Predicate Device:

- 1. Chem 1 Calibration Verification Test Set (K012117), manufactured by Maine Standards Company, Windham, ME.
- 2. Bio-Rad Liquichek Urine Chemistry Control (K934357), Bio-Rad Laboratories, Irvine, CA
- 3. College of American Pathologists (CAP) Urine Chemistry Survey (Calibration Verification / Linearity) LN6-B 2004, Northfield, IL

Device description: VALIDATE Urine Chemistry Calibration Verification Test Sets are human urine or serum 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 splutions.

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Intended use: The VALIDATE Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

| | VALIDATE Urine<br>Chemistry<br>Callbration<br>Verification Test Sets | CAP Urine<br>Chemistry<br>Survey | VALIDATE Chem<br>1 Calibration<br>Verification Test<br>Set | Bio-Rad<br>Liquichek™<br>Urine Chemistry<br>Control |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 701 / 702 / 703 | LN6-B 2004 | 101 | 398 |
| Intended<br>Use | For in vitro diagnostic<br>use in quantitatively<br>verifying calibration,<br>validating reportable<br>ranges, and<br>determining linearity in<br>automated, semi-<br>automated and manual<br>chemistry systems. | For use in<br>calibration<br>verification /<br>linearity testing of<br>clinical analyzers | For in vitro<br>diagnostic use in<br>quantitatively<br>verifying<br>calibration,<br>validating<br>reportable ranges,<br>and determining<br>linearity in<br>automated, semi-<br>automated and<br>manual chemistry<br>systems. | For in vitro use as<br>an assayed<br>quality control<br>urine to monitor<br>the precision of<br>laboratory testing<br>procedures for the<br>listed analytes. |
| Analytes | 701<br>UA, ETOH, NA, K, CL,<br>GLU, UUN, UTP<br>702<br>CA, MG, PHOS,<br>CREAT<br>AMY, p-AMY, MA,<br>703<br>serum osmo<br>urine osmo | AMY, CA, CREAT,<br>GLU, OSMO,<br>UTP, PHOS, K,<br>NA,<br>UUN, UA | NA, K, CL, CA,<br>PHOS GLU, BUN,<br>CRE, TRIG, MG,<br>LAC, LI | AMY, CA, CL,<br>CORTISOL,<br>CREAT, GLU,<br>MG, MA, OSMO,<br>PHOS, K, UTP,<br>NA, BUN, UUN,<br>UA |
| Matrix | human urine<br>human serum (osmo) | human urine | aqueous | human urine |
| Number of<br>Levels | 701 / 702<br>6 including zero<br>703<br>5 levels | 5 | 6 including zero | 1 |
| Preparation | Liquid, ready to use | Liquid, ready to<br>use | Liquid, ready to use | Liquid, ready to<br>use |
| Packaging | 3.0 mL each level | 5.0 mL each level | 5.0 mL each level | 10 mL |
| Stability | Until Expiration | 14 days | Until Expiration | 30 days after<br>opening |
| Storage | 2 to 8°C | 2 to 8°C | 2 to 8°C | 2 to 8°C |

TABLE 1: Comparison of VALIDATE Urine Chemistry Calibration Verification Test Sets to the predicate devices:

## Summary:

The information provided in this pre-market notification demonstrates that the performance of VALIDATE Urine Chemistry Calibration Test Sets is substantially equivalient I NO D COS . VALD Chemistry Survey (Calibration Verification Verification / Lineanity) LN6-B 2004, VALIDATE Chem 1 Calibration Verification Test Set (K012120), and Bio-Rad Liquichek Urine Chemistry Control (K934357) for its stated intended use

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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 depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 5 2005

Ms. Christine Beach Director, QA/RA Maine Standards Company 765 Roosevelt Trail Windham. ME 04062

Re: k050504

> Trade/Device Name: VALIDATE® Urine Chemistry Calibration Verification Test Sets Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 25, 2005 Received: March 2, 2005

Dear Ms. Beach:

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/industry/support/index.html

Sincerely yours,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, D.V.M. 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): _ K050504

Device Name: VALIDATE® Urine Chemistry Calibration Verification Test Sets

Indications For Use:

The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

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 Device Evaluation (ODE)

Carol Benson
Dixie Off

Diagnostic
and Safety

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