VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110

K023410 · Maine Standards Co. · JJY · Jan 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023410
• Device Name: VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE Chem 10 Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.

Device Story

VALIDATE Chem 10 Calibration Verification Test Set consists of purified enzymes in bovine albumin solution; provided in five levels per set. Used by trained laboratory professionals in clinical settings to verify calibration, validate reportable ranges, and determine linearity of automated/manual chemistry analyzers. Device serves as a quality control tool; provides known analyte concentrations to compare against analyzer output. Healthcare providers use results to confirm instrument performance and ensure accuracy of patient test results. Benefits include improved confidence in clinical chemistry measurements and adherence to laboratory quality standards.

Clinical Evidence

Bench testing only. Performance established via linear regression analysis comparing subject device to predicate devices. Correlation coefficients (r) for all analytes (ALP, ALT, AMY, AST, CK, GGT, LD, LIP, TBIL, Bu, Bc) ranged from 0.9932 to 0.9999, demonstrating functional equivalence.

Technological Characteristics

Purified enzymes in bovine serum albumin matrix. Liquid, ready-to-use form factor. Five levels per set. Storage at -10 to -20°C. Stability of 9 months. Analyte list: ALT, AST, CK, LD, ALP, AMY, LIP, GGT, TBIL, Bu/Bc.

Indications for Use

Indicated for use by trained laboratory professionals to determine linearity, verify calibration, and verify reportable ranges in automated, semi-automated, and manual clinical chemistry systems for specified enzymes and 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 Reflectance II Test Set (K910440)
• Ortho-Clinical Diagnostics VITROS Calibrator Kit 4

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The word "Maine" is written in a light color above a horizontal line. A thick black diagonal line crosses through the logo, intersecting the word "standards" written in bold black letters. Below "standards" is the text "COMPANY LLC" in smaller, spaced-out letters.

K623410

AN U 6 2003

### 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:

Maine Standards Company Submitter: 765 Roosevelt Trail Address: Windham, ME 04062 207-892-1300 Telephone: Fax: [phone] Contact: Christine Beach, Mgr. RA/QA

Summary prepared on: October 7, 2002

| Proprietary Name: | VALIDATE Chem 10 Calibration Verification Test Set |
|----------------------|----------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

### Predicate Device:

- DOCUMENT Reflectance II Test Set, K910440, manufactured by 1. CASCO NERL Diagnostics.
- Ortho-Clinical Diagnostics VITROS Calibrator Kit 4 2.

Device description: VALIDATE Chem 10 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains five (5) levels. Each bottle contains 5.0 milliliters.

Intended use: VALIDATE Chem 10 Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.

{1}------------------------------------------------

# Comparison to Predicate Devices:

| | VALIDATE CHEM 10<br>Calibration Verification<br>Test Set | DOCUMENT<br>Reflectance II<br>Test Set | Ortho-Clinical<br>Diagnostics VITROS<br>Calibrator Kit 4 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 110 | R-102 | 1204668 |
| Intended Use | For in vitro diagnostic use<br>in quantitatively verifying<br>calibration, validating<br>reportable ranges, and<br>determining linearity in<br>automated, semi-<br>automated and manual<br>chemistry systems. | For in vitro diagnostic<br>use in the<br>quantitative<br>determination of<br>linearity in manual,<br>automated and semi-<br>automated chemistry<br>systems. | For use in the<br>calibration of VITROS<br>chemistry systems for<br>the quantitative<br>measurement<br>of total and direct<br>bilirubin. |
| Analytes | ALT, AST, CK, LD, ALP,<br>AMY, LIP, GGT, TBIL,<br>Bu/Bc | ALT, AST, CK, LD,<br>ALP, AMY, GGT | TBIL, Bu/Bc |
| Matrix | Bovine Serum Albumin | Human Serum | Bovine Serum Albumin |
| Number of<br>Levels | 5 | 5 | 3 (TBIL)<br>4 (Bu/Bc) |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use | Lyophilizied |
| Packaging | 5.0 mL each level | 2 x 2.0 mL each level | 3 mL each level |
| Stability | 9 months | 9 months | 24 hours after<br>reconstitution |
| Storage | -10 to -20° C. | -10 to -20° C. | -10 to -20° C. |

The performance of VALIDATE Chem 10 Calibration Verification Test Set solutions on the Ortho-Clinical Diagnostics VITROS instrument system as compared to DOCUMENT Reflectance II Test Set and Ortho-Clinical Diagnostics Calibrator Kit 4 has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 10 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 10 Calibration Verification Test Set and the predicate devices are presented in Table 2.

{2}------------------------------------------------

| Table 2. | Linear Regression Statistical Comparison between VALIDATE Chem |
|----------|-----------------------------------------------------------------|
| | 10 Calibration Verification Test Set and the predicate devices. |

| | VALIDATE<br>Chem 10<br>Calibration Verification Test Set | | DOCUMENT<br>Reflectance II Test Set | |
|---------|----------------------------------------------------------|-------------------------------------------------|-------------------------------------|-------------------------------------------------|
| Analyte | Correlation<br>Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation<br>Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept |
| ALP | 0.9973 | 0.8898x + 42.375 | 0.994 | 0.978x - 35.071 |
| ALT | 0.9995 | 0.9722x - 0.0781 | 0.999 | 1.029x - 9.414 |
| AMY | 0.9983 | 0.9189x + 26.206 | 0.999 | 1.002x - 16.822 |
| AST | 0.9990 | 1.0521x - 11.729 | 0.998 | 0.982x - 4.709 |
| CK | 0.9932 | 0.814x + 59.839 | 0.999 | 0.974x + 8.122 |
| GGT | 0.9975 | 1.0994x - 17.786 | 0.999 | 0.987x + 4.625 |
| LD | 0.9997 | 1.0462x - 26.754 | 0.998 | 0.914x + 65.613 |
| LIP | 0.9999 | 0.9779x + 10.265 | 0.998 | 1.019x - 51.514 |

| VALIDATE<br>Chem 10<br>Calibration Verification Test Set | | Ortho-Clinical Diagnostics VITROS<br>Calibrator Kit 4 | | |
|----------------------------------------------------------|-----------------------------------|-------------------------------------------------------|-----------------------------------|-------------------------------------------------|
| Analyte | Correlation<br>Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation<br>Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept |
| TBIL | 0.9999 | 0.9887x + 0.0423 | 0.9999 | 0.9537x + 0.1719 |
| Bu | 0.999 | 0.9463x + 0.0471 | 0.9999 | 0.9765x + 0.0402 |
| Bc | 0.9995 | 0.9662x + 0.1465 | 0.9996 | 0.9899x - 0.0115 |

## Summary:

Linear regression analysis was carried out on recovered values for each analyte and Elliour rogression and Jels was cation Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to Tanonally - Squrrater.ce II Test Set and Ortho-Clinical Diagnostics Calibrator Kit 4.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a simple, modern design. The text "DEPARTMENT OF HEALTH" is arranged in a circular pattern around the left side of the logo.

# Rockville MD 20850

# JAN 0 6 2003

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

Re: k023410

> Trade/Device Name: Validate Chem 10 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 8, 2002 Received: October 10, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{4}------------------------------------------------

Page 2 - -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Validate Chem 10 Calibration Verification Test Set

#### Indications for Use:

The VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.

Sean Cooper

---

(Division Sign-Off)
Division of Clinical Laboratory Devices

023410

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use