VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

K013265 · Maine Standards Co. · JJY · Nov 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013265
• Device Name: VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VALIDATE Chem 7 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 analytes; iron, creatinine, ammonia, and ethanol.

Device Story

VALIDATE Chem 7 Calibration Verification Test Set is an aqueous-based, multi-level (6 levels including zero) test set. Used in clinical laboratory settings by trained professionals to verify calibration, validate reportable ranges, and determine linearity of chemistry systems. Device provides known concentrations of iron, creatinine, ammonia, and ethanol. Laboratory professionals compare instrument-measured values against expected values to assess system performance and accuracy. This process ensures clinical chemistry analyzers are operating within specifications, supporting reliable diagnostic testing for patients.

Clinical Evidence

Bench testing only. Performance evaluated via linear regression analysis comparing subject device to predicates on a Beckman CX instrument system. Analytes (iron, creatinine, ammonia, ethanol) tested in triplicate. Results showed high correlation (r values ranging from 0.99952 to 0.99998), confirming functional equivalence for calibration verification and linearity assessment.

Technological Characteristics

Aqueous-based, multi-analyte calibration verification test set. Contains 6 levels (including zero) in 5 mL bottles. Analytes: iron, creatinine, ammonia, ethanol. Storage: 2-8°C. Ready-to-use liquid form factor. No energy source or software components.

Indications for Use

Indicated for use by trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual chemistry systems for iron, creatinine, ammonia, and ethanol analysis.

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

• Iron/Magnesium/Triglyceride CAL-VER (K893142)
• Multi-Analyte CAL-VER (K870252)
• Ammonia/Ethanol CAL-VER (K962629)

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 logo is divided by a diagonal line, with "maine" on the top left and "standards" on the bottom right. The text "NOV 20 2001" is also visible on the right side of the image.

#### 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: September 27, 2001

| Proprietary Name: | VALIDATE Chem 7 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

#### Predicate Devices:

- DOCUMENT Iron/Magnesium/Triglyceride 1. CAL-VER. K893142. manufactured by CASCO NERL Diagnostics.
- 2. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO-NERL Diagnostics.
- DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by 3. CASCO-NERL Diagnostics.

Device description: VALIDATE Chem 7 Calibration Verification Test Set is an aqueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 7 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 analytes: iron, creatinine, ammonia, and ethanol.

7 6 5 R O O S E V E L T T A I L . W I N D H A M , M A I N E 0 4 0 6 2 TEL:[phone] · FAX:[phone] · TOLL-FREE:800.377.968 www.mainestandards.com

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## Comparison of VALIDATE Chem 7 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 7 Calibration Verification Test Set with those of the DOCUMENT Iron/Magnesium/Triglyceride CAL�VER, Multi-Analyte CAL.VER, and DOCUMENT Ammonia/Ethanol DOCUMENT CAL·VER.

| | VALIDATE<br>CHEM 7<br>Calibration<br>Verification<br>Test Set | DOCUMENT<br>Iron,<br>Magnesium,<br>Triglyceride<br>CAL•VER | DOCUMENT<br>Multi-Analyte<br>CAL•VER | DOCUMENT<br>Ammonia /<br>Ethanol<br>CAL•VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10007 | M-103 | M-100 | M-108 |
| Intended<br>Use | For in vitro<br>diagnostic use in<br>quantitatively<br>verifying<br>calibration,<br>validating<br>reportable<br>ranges, and<br>determining<br>linearity in<br>automated, semi-<br>automated and<br>manual<br>chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. |
| Analytes | FE, CRE, NH3,<br>ETOH | FE, MG, TRIG | GLU, BUN, NA,<br>K, CL, CRE, CA,<br>PO4 | NH3, ETOH |
| Matrix | aqueous | aqueous | aqueous | aqueous |
| Number of<br>Levels | 6 including Zero | 5 | 5 | 5 |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use | Liquid,<br>ready to use | Liquid,<br>ready to use |
| Packaging | 5.0 mL each<br>level | 10.0 mL each<br>level | 15 mL each level | 3.0 mL each<br>level |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 18-25°C | 2-8°C |

| TABLE 1. | Comparison of Products |
|----------|------------------------|
|----------|------------------------|

The performance of VALIDATE Chem 7 Calibration Verification Test Set solutions Beckman CX instrument system as compared to DOCUMENT on the Iron/Magnesium/Triglyceride CAL•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL.•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 7 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 7 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 7 Calibration Verification Test Set to the predicate devices.

| VALIDATE<br>Chem 7<br>Calibration Verification Test Set | | | DOCUMENT<br>Iron, Magnesium, Triglyceride<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) |
| FE | 0.99997 | .327 + 1.001X | 0.99979 | -5.539 + 1.007X |
| | VALIDATE<br>Chem 7<br>Calibration Verification Test Set | | DOCUMENT<br>Multi-Analyte<br>CAL•VER | |
| Analyte | Correlation<br>Coefficient (r) | Regression Equation<br>Y = intercept + slope(X) | Correlation<br>Coefficient (r) | Regression Equation<br>Y = intercept + slope(X) |
| CRE | 0.99952 | .091 + .983X | 0.99987 | -.099 + 1.007X |

| | VALIDATE<br>Chem 7<br>Calibration Verification Test Set | | DOCUMENT<br>Ammonia/Ethanol<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) |
| NH3 | 0.99994 | -.363 + 1.019X | 0.99809 | -11.616 + 1.074X |
| ETOH | 0.99998 | -.159 + 1.009X | 0.99872 | -1.261 + 1.04X |

#### Summary:

Linear regression analysis was carried out on recovered values for iron, creatinine, ammonia, and ethanol. The analytes were tested in triplicate. The VALIDATE Chem 7 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL.•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL•VER.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 2 0 2001

k013265 Re:

R013205
Trade/Device Name: VALIDATE Chem 7 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: September 27, 2001 Received: October 1, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 for use sualed in the encreating of the enactment date of the Medical Device Amendments, or to conimores prior to ria) 20, 20, 20, 20, 2017 11:25 provisions of the Federal Food, Drug, de nees that have been route approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , there core, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or babyer to oach as out 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 r loase of actived that i Drivination that your device complies with other requirements of the Act that I Dri has made a avad regulations administered by other Federal agencies. You must or any I 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 Of It in the quality systems (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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Page 2 -

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 nredicate 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 2 0 2001

### INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: VALIDATE Chem 7 Calibration Verification Test Set

#### Indications for Use:

The VALIDATE Chem 7 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 analytes; iron, creatinine, ammonia, 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 and ethanol. STIN

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013265

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use