VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108

K020450 · Maine Standards Co. · JJY · Mar 21, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020450
• Device Name: VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VALIDATE Chem 8 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium and chloride.

Device Story

VALIDATE Chem 8 Calibration Verification Test Set consists of purified chemicals in an aqueous base; provided in five levels to establish relationship between theoretical operation and actual performance of chemistry analyzers. Used in clinical laboratory settings by trained professionals to verify calibration, validate reportable ranges, and determine linearity of automated chemistry systems employing direct ion selective technology. Output is a set of recovered values compared against expected values to ensure system accuracy. Benefits include improved confidence in clinical chemistry results and regulatory compliance for laboratory quality control.

Clinical Evidence

Bench testing only. Performance evaluated via linear regression analysis comparing recovered values of the subject device against the predicate device on the AVL 9180 Electrolyte Analyzer and Beckman Synchron CX. Correlation coefficients (r) for Li, Na, K, and Cl ranged from 0.9998 to 1.0, demonstrating high correlation and functional equivalence.

Technological Characteristics

Aqueous-based multi-analyte calibrator containing purified Li, Na, K, and Cl. Provided in 5 levels, 3.0 mL per bottle. Ready-to-use liquid format. Storage at 2-8°C. Designed for use with automated chemistry systems employing direct ion selective technology.

Indications for Use

Indicated for use by trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated chemistry systems measuring lithium, sodium, potassium, and chloride.

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 Direct ISE CAL-VER (K881773)

Reference Devices

• AVL 9180 Electrolyte Analyzer
• Beckman Synchron CX

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The words "maine" and "standards" are separated by a diagonal line. Below "standards" is the text "COMPANY LLC". To the right of the logo is the text "MAR 21".

#### 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 807.92.2

"The assigned 510(k) number is: KOLOUSO

| 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: February 6, 2002

| Proprietary Name: | VALIDATE Chem 8 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

#### Predicate Device:

DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.

Device description: VALIDATE Chem 8 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of five (5) levels. Each bottle contains 3.0 milliliters.

Intended use: VALIDATE Chem 8 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium, and chloride.

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Comparison of VALIDATE Chem 8 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 8 Calibration Verification Test Set with those of DOCUMENT Direct ISE CAL•VER.

| | VALIDATE CHEM 8<br>Calibration Verification Test Set | DOCUMENT<br>Direct ISE CAL•VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 108 | M-101 |
| Intended Use | For <i>in vitro</i> diagnostic use in<br>quantitatively verifying calibration,<br>validating reportable ranges, and<br>determining linearity in automated,<br>semi-automated and manual<br>chemistry systems. | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of<br>linearity in manual, automated<br>and semi-automated chemistry<br>systems. |
| Analytes | Li, NA, K, CL | Li, NA, K, CL |
| Matrix | aqueous | aqueous |
| Number of<br>Levels | 5 | 5 |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use |
| Packaging | 3.0 mL each level | 10.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | 2-8°C | 18-25°C |

#### Comparison of Products TABLE 1.

The performance of VALIDATE Chem 8 Calibration Verification Test Set solutions on the AVL 9180 Electrolyte Analyzer, AVL Scientific Corporation, Roswell, GA, for lithium, sodium and potassium and the Beckman Synchron CX, Beckman Coulter, Inc. Fullerton. CA. for chloride as compared to DOCUMENT Direct ISE CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 8 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 8 Calibration Verification Test Set and the predicate devices are presented in Table 2.

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| TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 8 | |
|----------------------------------------------------------------------|--|
| Calibration Verification Test Set to the predicate devices. | |

| | VALIDATE<br>Chem 8<br>Calibration Verification Test Set | | DOCUMENT<br>Direct ISE<br>CAL·VER | |
|---------|---------------------------------------------------------|-----------------------------------------------|-----------------------------------|-----------------------------------------------|
| Analyte | Correlation Coefficient<br>(r) | Regression Equation<br>Y=intercept + slope(X) | Correlation Coefficient<br>(r) | Regression Equation<br>Y=intercept + slope(X) |
| Li | 1.0 | 1.0011x - 0.0102 | 1.0 | 1.0162x - 0.0685 |
| NA | 1.0 | x + 0.0867 | 0.9999 | 1.0437x + 0.1 |
| K | 0.9999 | 1.0004x - 0.0607 | 0.9999 | 1.1243x - 0.2693 |
| CL | 0.9998 | 1.0047x - 0.0248 | 0.9996 | 0.9601x + 7.5 |

### Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each Lifical Tegression analysic Mac camou but on Chem 8 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Direct ISE CAL•VER.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAR 2 1 2002

Ms. Christine Beach Manager, OA/RA Maine Standards Company 765 Roosevelt Trail - Suite 9A Windham, ME 04062

k020450 Re:

Trade/Device Name: VALIDATE Chem 8 Calibration Verification 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 6, 2002 Received: February 11, 2002

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 11 your de roo is exactive (controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/cdrb/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: KOZOYSO________________________________________________________________________________________________________________________________________________________

Device Name: VALIDATE Chem 8 Calibration Verification Test Set

Indications for Use:

The VALIDATE Chem 8 Calibration Verification Test Set is used by trained The VALIDATE onom o ounditatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems reportable ranges, and determinely more the following analytes: lithium, sodium, potassium and chloride.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 402 450

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