VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

K013119 · Maine Standards Co. · JJX · Nov 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013119
• Device Name: VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE Chem 6 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: uric acid.

Device Story

VALIDATE Chem 6 Calibration Verification Test Set is an aqueous-based, ready-to-use liquid test set containing six levels of uric acid (including zero). Used in clinical laboratories by trained professionals to verify calibration, validate reportable ranges, and determine linearity of chemistry analyzer systems. The device provides known concentrations of uric acid to compare against the analyzer's output. Healthcare providers use these results to ensure the accuracy and performance of their chemistry systems, ensuring reliable patient test results for uric acid levels.

Clinical Evidence

Bench testing only. Performance evaluated using pre-production lots on a Beckman Synchron CX instrument system. Linear regression analysis of uric acid recovery (tested in triplicate) demonstrated a correlation coefficient (r) of 0.99995, confirming functional equivalence to the predicate device.

Technological Characteristics

Aqueous-based liquid test set; 6 levels including zero; 5.0 mL per bottle; stored at 2-8°C. Ready-to-use. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use by trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of uric acid 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

• DOCUMENT Uric Acid CAL-VER (K893139)

Submission Summary (Full Text)

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NOV 1 6 2001

### 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: Kol3119

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

Summary prepared on: September 11, 2001

| Proprietary Name: | VALIDATE Chem 6 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Single Analyte |

### Predicate Devices:

- DOCUMENT Uric Acid CAL-VER, K893139, manufactured by CASCO 1. NERL Diagnostics.
Device description: VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analyte. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 6 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: uric acid.

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# Comparison of VALIDATE Chem 6 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 6 Calibration Verification Test Set with those of the DOCUMENT Uric Acid CAL.•VER.

| | VALIDATE CHEM 6<br>Calibration Verification Test<br>Set | DOCUMENT<br>Uric Acid CAL•VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10006 | M-106 |
| Intended Use | For in vitro diagnostic use in<br>quantitatively verifying<br>calibration, validating reportable<br>ranges, and determining<br>linearity in automated, semi-<br>automated and manual<br>chemistry systems. | For in vitro diagnostic use in the<br>quantitative determination of<br>linearity in manual, automated<br>and semi-automated chemistry<br>systems. |
| Analytes | Uric Acid | Uric Acid |
| Matrix | aqueous | aqueous |
| Number of<br>Levels | 6 including Zero | 5 |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use |
| Packaging | 5.0 mL each level | 5.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C |

#### Comparison of Products TABLE 1.

The performance of VALIDATE Chem 6 Calibration Verification Test Set solutions on the Beckman Synchron CX instrument system as compared to DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 6 Calibration Verification Test Sets. The results of correlation comparisons between the VALIDATE Chem 6 Calibration Verification Test Set and the predicate device are presented in Table 2.

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#### Linear Regression Statistical Comparison of VALIDATE Chem 5 TABLE 2. Calibration Verification Test Set to the predicate device.

| | VALIDATE<br>Chem 6<br>Calibration Verification Test Set | | DOCUMENT<br>Uric Acid<br>CAL·VER | |
|---------|---------------------------------------------------------|-----------------------------------------------|-----------------------------------|-----------------------------------------------|
| Analyte | Correlation<br>Coefficient (r) | Regression Equation<br>Y=intercept + slope(X) | Correlation<br>Coefficient<br>(r) | Regression Equation<br>Y=intercept + slope(X) |
| UA | 0.99995 | $.031 + .956(x)$ | 0.99996 | $.155 + .91(x)$ |

### Summary:

Linear regression analysis was carried out on recovered values for uric acid. The analyte was tested in triplicate. The VALIDATE Chem 6 Calibration Verification andition was been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Uric Acid CAL•VER.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

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

K013119 Re:

Trade/Device Name: VALIDATE Chem 6 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 - 862.1660 - 862.1775 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: I Reserved Product Code: JJX Dated: September 11, 2001 Received: September 18, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general of 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 6 2001

### INDICATIONS FOR USE STATEMENT

510(k) Number: Kol3119

Device Name: VALIDATE Chem 6 Calibration Verification Test Set

## Indications for Use:

The VALIDATE Chem 6 Calibration Verification Test Set is 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 following analyte: uric acid.

Jean Cooper
(Division Si
Division of (

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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Over-The-Counter Use