VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109

K023352 · Maine Standards Co. · JJY · Nov 22, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023352
• Device Name: VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes. albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.

Device Story

VALIDATE Chem 9 Calibration Verification Test Set consists of purified chemicals in bovine serum albumin matrix; provided in five levels to establish relationship between theoretical and actual performance of 18 clinical chemistry analytes. Used in clinical laboratories by trained professionals to verify calibration, validate reportable ranges, and determine linearity of chemistry systems. Device is liquid, ready-to-use. Healthcare providers use output to confirm instrument accuracy and reportable range, ensuring reliable patient test results. Benefits include improved quality control and confidence in clinical chemistry measurements.

Clinical Evidence

Bench testing only. Linear regression analysis performed on pre-production lots comparing subject device to predicates. Each analyte tested in triplicate. Results demonstrated high correlation coefficients (r > 0.99) for all analytes, confirming functional equivalence for calibration verification and linearity assessment.

Technological Characteristics

Matrix: Bovine serum albumin. Form: Liquid, ready-to-use. Levels: 5. Storage: -10 to -20°C. Analytes: 18 (ALB, CA, CHOL, CL, CO2, CRE, GLU, FE, LAC, LI, MG, PO4, K, NA, TP, TRIG, BUN, UA).

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual clinical chemistry systems for 18 specific analytes (ALB, CA, CHOL, CL, CO2, CRE, GLU, FE, LAC, LI, MG, PO4, K, NA, TP, TRIG, BUN, UA).

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 Serum Multi-Analyte CAL-VER (K950469)
• Ortho-Clinical Diagnostics VITROS Calibrator Kit 1

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 on the top left, and the word "standards" is on the bottom right. A diagonal line separates the two words, and the words "COMPANY LLC" are below the word "standards".

1023352

NOV 22 2002

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

Summary prepared on: September 30, 2002

| Proprietary Name: | VALIDATE Chem 9 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |

### Predicate Devices:

- 1. DOCUMENT Serum Multi-Analyte CAL-VER, K950469, manufactured by CASCO NERL Diagnostics.
- 2. Ortho-Clinical Diagnostics VITROS Calibrator Kit 1

Device description: VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. 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 5 milliliters.

Intended use: VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).

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

# Comparison of VALIDATE Chem 9 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 9 Calibration Verification Test Set with those of the DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.

| | VALIDATE CHEM 9<br>Calibration<br>Verification Test Set | DOCUMENT Serum<br>Multi-Analyte<br>CAL·VER | Ortho-Clinical<br>Diagnostics VITROS<br>Calibrator Kit 1 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Catalog # | 109 | M-115 | 1882208 |
| Intended Use | For in vitro diagnostic<br>use in quantitatively<br>verifying calibration,<br>validating reportable<br>ranges, and<br>determining linearity in<br>automated, semi-<br>automated and manual<br>chemistry systems | For in vitro diagnostic<br>use in the 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 lactate. |
| Analytes | ALB, CA, CHOL, CL,<br>CO2, CREAT, GLU, FE,<br>LAC, LITH, MG, PO4,<br>K, NA, TPROT, TRIG,<br>BUN, URIC ACID | ALB, CA, CHOL, CL,<br>CO2, CREAT, GLU, FE,<br>LITH, MG, PO4, K, NA,<br>TPROT, TRIG, BUN,<br>URIC ACID | LAC |
| Matrix | Bovine serum albumin | Human serum | Bovine serum albumin |
| Number of<br>Levels | 5 | 5 | 3 |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use | Lypholized |
| Packaging | 5.0 mL each level | 2 x 3.0 mL each level | 3.0 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 |

#### Comparison of Products TABLE 1.

The performance of VALIDATE Chem 9 Calibration Verification Test Set solutions on the VITROS instrument system as compared to DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1 been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 9 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 9 Calibration Verification Test Set and the predicate devices are presented in Table 2.

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

| | | VALIDATE | DOCUMENT | |
|--------------|------------------------------------------|-------------------------------------------------|--------------------------------|-------------------------------------------------|
| | Chem 9 Calibration Verification Test Set | | Serum Multi-Analyte CAL•VER | |
| Analyte | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept |
| ALB | 0.9942 | x - 0.1 | 0.998 | 0.997x + 0.022 |
| BUN | 0.9999 | 1.0138x - 0.4276 | 0.999 | 1.005x + 0.618 |
| CA | 0.9974 | 1.01x + 0.288 | 0.999 | 0.995x + 0.035 |
| CHOL | 0.9999 | 0.9935x + 1.8102 | 0.995 | 1.058x - 6.192 |
| CL | 0.9996 | 0.9581x + 3.6226 | 0.998 | 1.010x - 1.389 |
| CO2 | 0.9971 | 0.875x + 1.675 | 0.998 | 1.009x - 0.176 |
| CRE | 0.9986 | 0.9364 + 0.1791 | 0.999 | 0.974x + 0.073 |
| FE | 0.9988 | 0.9205x + 14.617 | 0.998 | 1.119x - 14.492 |
| GLU | 0.9999 | 1.0132x - 0.7707 | 0.999 | 1.050x - 9.370 |
| K | 0.9987 | 0.9984x - 0.2576 | 0.999 | 0.983 + 0.170 |
| LITH | 0.9997 | 0.9733x + 0.0187 | 0.994 | 0.924x + 0.015 |
| MG | 0.9993 | 0.9832 + 0.1053 | 0.998 | 1.051x - 0.082 |
| NA | 0.9991 | 1.0042x + 1.8979 | 0.998 | 1.076x - 7.561 |
| PO4 | 0.9998 | 0.975x + 0.035 | 0.999 | 0.992x + 0.093 |
| TP | 0.9986 | 1.097x - 0.5097 | 0.998 | 1.086x - 0.261 |
| TRIG | 0.9999 | 1.0226x - 3.6259 | 0.999 | 1.018x + 2.292 |
| URIC<br>ACID | 0.9997 | 0.97x + 0.161 | 0.999 | 0.992x + 0.040 |

| | | TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 9 | | |
|--|--|----------------------------------------------------------------------|--|--|
| | | Calibration Verification Test Set to the predicate devices. | | |

| VALIDATE<br>Chem 9<br>Calibration Verification Test Set | | | Ortho-Clinical Diagnostics VITROS<br>Calibrator Kit 1 | | |
|---------------------------------------------------------|--------------------------------|-------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|--|
| Analyte | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | |
| LAC | 1.0000 | 1.012x - 0.0272 | 0.9995 | 0.9398x + 0.0692 | |

## Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 9 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Serum Multi-Analyte CAL.�VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of three birds in flight, one behind the other. The birds are black and have a simple, abstract design.

od and Drug Administra 98 Gaither Road ckville MD 20850

## OV 22 2002

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

Re: k023352

> Trade/Device Name: Validate Chem 9 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: September 30, 2002 Received: October 7, 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. Iisting 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 – 2017 - 12:00 PM - 12 - 11:00 PM - 12 - 11 - 12 - 11 - 11 - 11 - 11 - 1
- 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -

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 Sutman

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 9 Calibration Verification Test Set

#### Indications for Use:

The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes. albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.

Gran Crogn

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023352

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use