VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005

K012122 · Maine Standards Co. · JJX · Aug 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012122
• Device Name: VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VALIDATE Chem 5 Calibration Verification Test Set is used by trained professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: iron.

Device Story

VALIDATE Chem 5 Calibration Verification Test Set is a liquid, human serum-based, ready-to-use test set; contains six levels of iron analyte, including zero. Used in clinical laboratory settings by trained professionals to verify calibration, validate reportable ranges, and determine linearity of chemistry systems. Device provides known concentrations to compare against instrument output; results allow clinicians to ensure accuracy of patient iron testing. Benefits include improved confidence in diagnostic results and maintenance of instrument performance standards.

Clinical Evidence

Bench testing only. Performance compared to predicate device using pre-production lots on Roche Diagnostics Hitachi 911 instrument. Linear regression analysis performed on iron analyte tested in triplicate. Results showed high correlation (r=0.99999) and functional equivalence to the predicate.

Technological Characteristics

Liquid, human serum-based matrix; ready-to-use. Six levels including zero. Storage at 2-8°C. Analyte: Iron. No electronic or software components; purely a chemical calibration verification test set.

Indications for Use

Indicated for use by trained professionals to verify calibration, validate reportable ranges, and determine linearity of iron 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 Iron/Magnesium/Triglyceride CAL-VER (K893142)

Submission Summary (Full Text)

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## 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: ________ "

| 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: June 29, 2001

| Proprietary Name: | VALIDATE Chem 5 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

### Predicate Devices:

- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, 1. manufactured by CASCO NERL Diagnostics.
Device description: VALIDATE Chem 5 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used 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 5 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: iron.

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## Comparison of VALIDATE Chem 5 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 5 Calibration Verification Test Set with those of the DOCUMENT Iron/Magnesium/Triglyceride CAL.�VER.

| | VALIDATE CHEM 3<br>Calibration Verification Test<br>Set | DOCUMENT<br>Iron, Magnesium, Triglyceride<br>CAL·VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10003 | M-103 |
| 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 | FE | FE |
| 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 | 10.0 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 5 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Iron/Magnesium/Triglyceride CAL.�VER, has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 5 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 5 Calibration Verification Test Set and the predicate device are presented in Table 2.

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

| VALIDATE<br>Chem 5<br>Calibration Verification Test Set | | DOCUMENT<br>Iron, Magnesium, Triglyceride<br>CAL•VER | | |
|---------------------------------------------------------|-----------------------------|------------------------------------------------------|-----------------------------|-----------------------------------------------|
| Analyte | Correlation Coefficient (r) | Regression Equation<br>Y=intercept + slope(X) | Correlation Coefficient (r) | Regression Equation<br>Y=intercept + slope(X) |
| FE | 0.99999 | 1.498 + .992 | 0.99992 | -3.464 + 1.021 |

## Summary:

Linear regression analysis was carried out on recovered values for iron. The analyte was tested in triplicate. The VALIDATE Chem 5 Calibration Verification Test Set has been shown to be functionally equivalent for calibration venfication and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL•VER.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

510(k) Number: K012122 Re: Trade/Device Name: VALIDATE Chem 5 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJX Dated: July 3, 2001 Received: July 6, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Amendments, 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 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 (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 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 Butman

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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## INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: VALIDATE Chem 5 Calibration Verification Test Set

Indications for Use:

The VALIDATE Chem 5 Calibration Verification Test Set is used by trained I the VALIDATE onomals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: iron.

# Concurrence of CDRH, Office of Device Evaluation (ODE)

\$\checkmark\$ Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Kesia Alexander de Jean Conper

510(k) Number