VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

K012120 · Maine Standards Co. · JJY · Aug 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012120
• Device Name: VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE Chem 4 Calibration Verification 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: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin, and direct bilirubin.

Device Story

VALIDATE Chem 4 Calibration Verification Test Set consists of six levels of purified enzymes in a bovine albumin solution stabilized with ethylene glycol. Used in clinical laboratory settings by trained professionals to verify calibration, validate reportable ranges, and determine linearity of chemistry analyzer systems. The device provides a known relationship between theoretical performance and actual instrument output. By testing these samples, laboratory staff compare recovered values against expected values to ensure instrument accuracy and linearity across the reportable range. This process helps maintain the reliability of clinical chemistry results, supporting accurate diagnostic decision-making for patients.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing recovered values of the VALIDATE Chem 4 Test Set against predicate devices using the Roche Diagnostics Hitachi 911 instrument. Linear regression analysis across ten analytes (ALT, AST, GGT, CK, LD, ALP, AMY, LIP, Total Bilirubin, Direct Bilirubin) showed correlation coefficients (r) ranging from 0.99113 to 0.99999, confirming functional equivalence to the predicate devices.

Technological Characteristics

Matrix: Bovine serum albumin stabilized with ethylene glycol. Form: Liquid, ready-to-use. Levels: 6 (including zero). Volume: 5 mL per bottle. Storage: -10 to -20°C. Analyte list: ALT, AST, CK, LD, ALP, AMY, LIP, GGT, Total Bilirubin, Direct Bilirubin.

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 alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin, and direct bilirubin.

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 Enzyme Linearity Test Set (K932458)
• DOCUMENT Total/Direct Bilirubin Test Set (K924493)
• Lipase LIN-TROL (K863751)

Submission Summary (Full Text)

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# MAINE STANDARDS COMPANY, LLC

AUG 2 0 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: Holalao .."

| 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 4 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

## Predicate Devices:

- DOCUMENT Enzyme Linearity Test Set, K932458, manufactured by 1. CASCO NERL Diagnostics.
- DOCUMENT Total/Direct Bilirubin Test Set, K924493, manufactured by 2. CASCO NERL Diagnostics.
- Lipase LIN-TROL, K863751, manufactured by Sigma Diagnostics, Inc. ന്

Device description: VALIDATE Chem 4 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin stabilized with ethylene glycol. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 4 Calibration Verification 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: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin, and direct bilirubin.

> Office location . 765 Roosevelt Trail . Windham, Maine 04062 Mailing address · P.O. Box 8360 · Portland, ME 04104-8360 Tel. [phone] · Fax [phone] · Toll Free 800-377-9684

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# Comparison to Predicate Devices:

| | VALIDATE | DOCUMENT | DOCUMENT | Sigma |
|--------------|--------------------------|-------------------|-----------------------|-----------------------------|
| | CHEM 4 | Enzyme | Total/Direct | Lipase Lin-Trol |
| | Calibration | Linearity Test | Bilirubin<br>Test Set | |
| | Verification Test<br>Set | Set | | |
| | | | | |
| Catalog # | 10004 | E-100 | M-107 | L 1401 |
| | For in vitro | For in vitro | For in vitro | For estimating the |
| | | diagnostic use in | diagnostic use in | limits of linearity |
| | | the quantitative | the quantitative | and/or calibration |
| | | determination of | determination of | verification of |
| | | linearity in | linearity in | reagent/ |
| | | manual, | manual, | instrument |
| | | automated and | automated and | systems. |
| Intended Use | | semi-automated | semi-automated | |
| | | ranges, and | chemistry | chemistry |
| | | determining | systems. | systems. |
| | | linearity in | | |
| | | automated, semi- | | |
| | | automated and | | |
| | | manual chemistry | | |
| | systems. | | | |
| | ALT, AST, CK, | | | |
| | LD, ALP, AMY, | ALT, AST, CK, | Total Bilirubin | Lipase |
| Analytes | LIP, GGT, Total | LD, ALP, AMY, | Direct Bilirubin | |
| | Bilirubin, and | GGT | | |
| | Direct Bilirubin | | | |
| | Bovine Serum | Bovine Serum | | Human Serum |
| Matrix | Albumin | Albumin | Human Serum | Base with Porcine<br>Lipase |
| | stabilized with | stabilized with | Albumin | |
| | Ethylene Glycol | Ethylene Glycol | | |
| | | | | |
| Number of | | | | 1 Preparation |
| Levels | 6 including Zero | 8 including Zero | 5 | with various<br>dilutions |
| Preparation | Liquid, | Liquid, | Liquid, | |
| | ready to use | ready to use | ready to use | Lyophilized |
| | | | | 3 mL freeze dried |
| Packaging | 5.0 mL each level | 5.0 mL each level | 4.0 mL each level | concentrate |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | -10 to -20° C. | -10 to -20° C. | -10 to -20° C. | 2- 4° C. |

The performance of VALIDATE Chem 4 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Bilirubin Test Set, and Sigma Diagnostics Lipase LIN-TROL has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 4 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 4 Calibration Verification Test Set and the predicate devices are presented in Table 2.

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K012120

| Table 2. | Linear Regression Statistical Comparison between VALIDATE Chem 4<br>Calibration Verification Test Set and the predicate devices. |
|----------|----------------------------------------------------------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------------------------------------------------------|

| | VALIDATE Chem 4<br>Calibration<br>Verification Test Set | | DOCUMENT<br>Enzyme Linearity<br>Test Set | | DOCUMENT<br>Total/Direct Bilirubin<br>Test Set | | Sigma Diagnostics<br>Lipase LIN-TROL | |
|---------|---------------------------------------------------------|-----------------------------------------------------|------------------------------------------|-----------------------------------------------------|------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------|
| Analyte | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) |
| ALT | 0.999945 | 6.121 +<br>.928 | 1.00000 | -.141 +<br>.996 | N/A | N/A | N/A | N/A |
| AST | 0.99964 | 4.351 +<br>.949 | 0.99992 | -4.055 +<br>1.022 | N/A | N/A | N/A | N/A |
| GGT | 0.99995 | -.026 +<br>.989 | 0.99997 | -2.83 +<br>1.006 | N/A | N/A | N/A | N/A |
| CK | 0.99113 | -8.94 +<br>.937 | 0.99992 | 10.354 +<br>.951 | N/A | N/A | N/A | N/A |
| LD | 0.99971 | 8.228 +<br>.953 | 0.99988 | 3.402 +<br>.954 | N/A | N/A | N/A | N/A |
| ALP | 0.99999 | -1.285 +<br>1.001 | 0.99999 | -.59 +<br>1.001 | N/A | N/A | N/A | N/A |
| AMY | 0.99998 | -3.311 +<br>1.003 | 0.99979 | 27.07 +<br>.945 | N/A | N/A | N/A | N/A |
| LIP | 0.99879 | -1.399 +<br>.965 | N/A | N/A | N/A | N/A | 0.99935 | 6.885 +<br>1.001 |
| T. BILI | 0.99956 | .236 +<br>.952 | N/A | N/A | 1.00000 | .02 +.99X | N/A | N/A |
| D.BILI | 0.99627 | .477 +.86 | N/A | N/A | 0.99999 | .027 +<br>1.018 | N/A | N/A |

## Summary:

Linear regression analysis was carried out on recovered values for each analyte and the VALIDATE Chem 4 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Billrubin Test Set, and Sigma Diagnostics Lipase LIN-TROL.

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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: K012120 Re: Trade/Device Name: VALIDATE Chem 4 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJY 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/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: Kolalao

Device Name: VALIDATE Chem 4 Calibration Verification Test Set

## Indications for Use:

The VALIDATE Chem 4 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin and direct bilirubin .

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Kesia Alexander Inchan Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K012120

OR

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