VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501

K041975 · Maine Standards Co. · JJY · Oct 15, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041975
• Device Name: VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VALIDATE Lipoprotein Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

Device Story

VALIDATE Lipoprotein Calibration Verification Test Set; quality control material for clinical chemistry systems. Input: human serum protein base containing Cholesterol, HDL, LDL, Apolipoprotein A, and Apolipoprotein B. Output: six levels of liquid, ready-to-use samples (including zero) used by laboratory professionals to assess linearity and calibration of automated, semi-automated, or manual chemistry analyzers. Device provides a reference for verifying reportable ranges of specific analytes. Used in clinical laboratory settings; results assist in ensuring accuracy of patient diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated using pre-production lots on Roche Hitachi 911 with Roche reagents; compared against College of American Pathologists (CAP) General Chemistry Survey C/CN-3 B 2004.

Technological Characteristics

Human serum-based multi-analyte control; liquid, ready-to-use; 6 levels including zero; 5 mL volume per bottle; stored at -10 to -20°C. Analyte panel: cholesterol, HDL, LDL, Apo-A, Apo-B.

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of clinical chemistry systems for Cholesterol, HDL, LDL, Apolipoprotein A, and Apolipoprotein B.

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

• VALIDATE Chem 4 Calibration Verification Test Set (k012120)

Submission Summary (Full Text)

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## 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: K041975."

| Submitter: | Maine Standards Company |
|------------|------------------------------------------|
| Address: | 765 Roosevelt Trail<br>Windham, ME 04062 |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Christine Beach, Dir. RA/QA |

Summary prepared on: July 14, 2004

Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device description: Quality control material (assayed and unassayed) Proprietary Name: VALIDATE Lipoprotein Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I

## Predicate Device:

- 1. Chem 4 Calibration Verification Test Set (K012120), manufactured by Maine Standards Company, Windham, ME.
Device description: VALIDATE Lipoprotein Calibration Test Set is a human protein serum 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. There exists a linear relationship among each set of solutions.

Intended use: VALIDATE Lipoprotein Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

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# Comparison of VALIDATE Lipoprotein Calibration Verification Test Set to the l
eather of the consideration Verification Test Set Companson on Calibration Verification Test Set:

The VALIDATE Lipoprotein Calibration Test Set is substantially equivalent to The VALIDATE Lipoprotein Calibration Test Set (K012120) also manufactured by
the VALIDATE Chem 4 Calibration Verification Test Set (K012120), for its sted use the VALIDATE Chem 4 Gallbration Vermoution 1000 The FDA, for its stated use.

| | VALIDATE Lipoprotein Calibration<br>Verification Test Set | VALIDATE Chem 4 Calibration<br>Verification Test Set |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | For in vitro diagnostic use in<br>quantitatively verifying calibration,<br>validating reportable ranges, and<br>determining linearity in automated,<br>semi-automated and manual chemistry<br>systems. | For in vitro diagnostic use in quantitatively<br>verifying calibration, validating reportable<br>ranges, and determining linearity in<br>automated, semi-automated and manual<br>chemistry systems. |
| Analytes | CHOL, HDL, LDL, Apo-A, Apo-B | ALP, ALT, AMY, AST, CK, GGT, LD,<br>LIP, TBIL, DBIL |
| Matrix | human serum | protein |
| Number of<br>Levels | 6 including zero | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 5.0 mL each level | 5.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | -10 to -20°C | -10 to -20°C |

### Summary:

The information provided in this pre-market notification demonstrates that the performance i he information provided in this pre-market is substantially equivalent in form of VALIDATE Lipoprolem Calibration Verification Test Set (K012120) for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 15 2004

Ms. Christine Beach Director QA/RA Maine Standards Co. 765 Roosevelt Trail Windham. ME 04062

Re: k041975

> Trade/Device Name: VALIDATE® Lipoprotein 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: July 22, 2004 Received: July 22, 2004

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).

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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 promated no dicate 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). You may obtain other general information on your responsibilities under the Act 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,

Seain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

**510(k) Number:** K041975

Device Name: VALIDATE® Lipoprotein Calibration Verification Test Set

# Indications for Use:

The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.

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

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041975