VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

K033879 · Maine Standards Co. · DKB · Feb 27, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033879
• Device Name: VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
• Applicant: Maine Standards Co.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The VALIDATE TDM Calibration Verification Test Set is used by trained laboratory professions 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 analytes: Acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin

Device Story

VALIDATE TDM Calibration Verification Test Set consists of purified chemicals in human serum matrix; provided in six levels including zero; 5 mL per bottle. Used by laboratory professionals in clinical chemistry systems to verify instrument performance, linearity, and reportable ranges for therapeutic drug monitoring. Device serves as a calibration verification tool; does not perform clinical diagnosis directly. Benefits include ensuring accuracy and reliability of clinical chemistry system results for therapeutic drug monitoring.

Clinical Evidence

No clinical data provided. Bench testing only; traceability established via NIST Standard Reference Materials (SRM 900 and 1599) or primary analytical standards.

Technological Characteristics

Purified chemicals in human serum matrix; liquid, ready-to-use form. 6 levels per set, 5 mL per bottle. Storage at 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by trained laboratory professionals to verify calibration, linearity, and reportable ranges for therapeutic drug monitoring analytes in clinical chemistry systems. No specific patient population or contraindications defined.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• TDM I CAL-VER (K913309)

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 word "maine" is on the top left, with a line going through it. The word "standards" is on the bottom right, and the words "COMPANY LLC" are below it in smaller letters.

FEB 2 7 2004

## 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: _ < 03387

| 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 |

December 11, 2003 Summary prepared on:

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

### Predicate Devices:

- 1. DOCUMENT TDM | CAL-VER. K913309. manufactured by CASCO NERL Diagnostics.
- 2. Human serum spiked with salicylate

Device description: VALIDATE TDM Calibration Verification Test Set contains purified chemicals in a human serum 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 six (6) levels including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE TDM 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 seventeen analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, tobramycin, valproic acid, and vancomycin.

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

Table 1 compares characteristics of the VALIDATE TDM Calibration Verification Test Set with those of the DOCUMENT TDM I CAL•VER.

| Catalog # | VALIDATE TDM Calibration<br>Verification Test Set | DOCUMENT<br>TDM<br>CAL•VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 126 | For <i>in vitro</i> diagnostic use in<br>quantitatively verifying calibration,<br>validating reportable ranges, and<br>determining linearity in automated,<br>semi-automated and manual<br>chemistry systems | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of<br>linearity in manual, automated and<br>semi-automated chemistry<br>systems. |
| Analytes | acetaminophen, amikacin,<br>carbamazepine, digoxin, gentamicin,<br>lidocaine, N-acetylprocainamide,<br>phenobarbital, phenytoin, primidone,<br>procainamide, quinidine, salicylate,<br>theophylline, tobramycin, valproic acid,<br>and vancomycin | acetaminophen, amikacin,<br>carbamazepine, chloramphenicol,<br>disopyramide, ethosuximide, digoxin,<br>gentamicin, lidocaine,<br>N-acetylprocainamide, phenobarbital,<br>phenytoin, primidone, procainamide,<br>quinidine, theophylline, tobramycin,<br>valproic acid, and vancomycin |
| Matrix | human serum | human serum |
| Number of<br>Levels | 6 | 8 |
| 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 | 2 to 8°C | 2 to 8°C |

#### TABLE 1. Comparison of Products

The performance of VALIDATE TDM Calibration Test Set solutions on the VITROS instrument system as compared to DOCUMENT TDM I CAL.aVER and human serum spiked with salicylate has been shown to be substantially equivalent using preproduction lots of VALIDATE TDM Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE TDM Calibration Test Set and the predicate devices are presented in Table 2.

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| | VALIDATE®<br>TDM | | DOCUMENT®<br>TDM I<br>CAL·VER | |
|---------|-----------------------------------|-------------------------------------------------|--------------------------------|-------------------------------------------------|
| | Calibration Verification Test Set | | | |
| Analyte | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept |
| ACET | 0.9981 | 0.936x + 2.65 | 0.9974 | 0.8718x + 10.14 |
| AMI | 0.9940 | 1.099x - 0.79 | 0.9971 | 1.0469x - 0.4331 |
| CARB | 0.9989 | 1.009x - 0.01 | 0.9973 | 1.04x + 0.15 |
| DIG | 0.9976 | 1.026x - 0.01 | 0.9979 | 1.015x - 0.02 |
| GENT | 0.9968 | 0.898x + 0.19 | 0.9939 | 0.8639x + 0.26 |
| LIDO | 0.9987 | 1.025x - 0.07 | 0.997 | 1.0727x - 0.1567 |
| NAPA | 0.9975 | 0.995x + 0.01 | 0.9971 | 1.0363x - 0.42 |
| PHENO | 0.9981 | 0.999x - 0.22 | 0.9974 | 0.9919x + 0.39 |
| PHENY | 0.9986 | 0.972x + 0.34 | 0.999 | 1.0025x + 0.10 |
| PRIM | 0.9994 | 1.036x - 0.18 | 0.9993 | 0.9831x - 0.0014 |
| PROC | 0.9971 | 1.015x - 0.06 | 0.9965 | 1.1413x - 1.0 |
| QUIN | 0.9994 | 1.043x - 0.05 | 0.9981 | 1.0541x - 0.08 |
| THEO | 0.9994 | 0.981x + 0.17 | 0.9992 | 0.9933x - 0.11 |
| TOB | 0.9985 | 1.077x - 0.16 | 0.9935 | 0.9278x + 0.38 |
| VPA | 0.999 | 1.037x - 1.17 | 0.9983 | 1.0231x - 0.65 |
| VANC | 0.9995 | 1.018x - 0.3 | 0.992 | 0.9688x + 0.12 |

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

| VALIDATE<br>TDM<br>Calibration Verification Test Set | | Spiked Human Serum | | |
|------------------------------------------------------|--------------------------------|-------------------------------------------------|--------------------------------|-------------------------------------------------|
| Analyte | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept | Correlation Coefficient<br>(r) | Regression Equation<br>Y = slope(X) + intercept |
| SALI | 0.9985 | $0.958x + 7.21$ | 0.9916 | $0.902x + 17.99$ |

## Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE TDM Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT TDM I CAL•VER and human serum spiked with salicylate.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird-like shape.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 27 2004

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

Re: k033879

> Trade/Device Name: Validate® TDM Calibration Verification Test Set Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: December 11, 2003 Received: December 16, 2003

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 (OS) regulation (21 CFR Part 820).

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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). 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.

Jean M. Cooper, MS, DVM.

Yean 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:** K033871

Device Name: Validate® TDM Calibration Verification Test Set

### Indications for Use:

The VALIDATE TDM 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 analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5704k k033879