AC/AD LINEARITY VERIFIERS

K982217 · Sc Calibrators & Controls, LLC · DIF · Jul 2, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982217
• Device Name: AC/AD LINEARITY VERIFIERS
• Applicant: Sc Calibrators & Controls, LLC
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jul 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

AC/AD Linearity Verifiers are intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs.

Device Story

AC/AD Linearity Verifiers are a five-level, multiconstituent set of human serum-based calibrators. Used in clinical laboratories to confirm calibration and linearity of therapeutic drug monitoring (TDM) methods. Levels 1-4 are related by linear dilution; Level 1 is zero-concentration; Level 5 is near the upper instrument limit. Assayed like patient samples on automated or manual TDM systems. Results assist clinicians in validating instrument performance and ensuring accurate patient drug concentration measurements. Not compatible with EMIT ethosuximide reagents due to matrix interference.

Clinical Evidence

Bench testing only. Performance validated on three automated TDM systems (Abbott TDx, Dade-Behring EMIT, Roche-Boehringer CEDIA), two colorimetric methods (acetaminophen, salicylate), and HPLC (nordiazepam). Results demonstrated desired functionality for most methods. Identified incompatibility with EMIT ethosuximide reagents due to matrix interference.

Technological Characteristics

Five-level multiconstituent calibrator set; human serum base matrix; non-azide proprietary preservative; gravimetric and traceable calibration; 11 analytes; compatible with automated/manual immunoassays and colorimetric methods (excluding EMIT ethosuximide).

Indications for Use

Indicated for use in clinical laboratories to verify calibration, linear operating range, and reportable range of therapeutic drug monitoring (TDM) methods and instruments. Not indicated for use with EMIT ethosuximide reagents.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• ABC Linearity Verifiers by SC Calibrators & Controls LLC

Submission Summary (Full Text)

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K982217
July 2, 1998

## 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:

Roy F. Schall, Jr., Ph.D. Contact Name:

June 11, 1998 Date:

Product Name: AC/ADtm Linearity Verifiers

Calibration Verifiers, Linearity Verifiers Common Names:

Predicate Devices: ABC:m Linearity Verifiers by SC Calibrators & Controls LLC

Description of the Device: medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). AC/AD Linearity Verifiers is a five level, multiconstituent set of calibrators made in human serum and used to confirm the proper calibration, linear operating range and reportable range (linearity) of TDM methods. The "AC/AD" designation derives from AntiConvulsant, antiAnxiety and other Qrugs. AC/AD Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level 5 has a concentration near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included.

Intended Use: AC/AD Linearity Verifiers are intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs.

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## Technical Characteristics Compared to Predicate Device:

## Comparison of Features of AC/AD Linearity Verifiers and the predicate device: ABC Linearity Veriflers.

| Attribute | AC/AD Linearity Verifiers | ABC Linearity Verifiers |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| No of Analytes | 11 | 12 |
| No of Levels | 5 | 5 |
| Vol per level (mL) | 5 | 5 |
| Type of Analytes | Therapeutic Drugs | Therapeutic Drugs |
| Method(s) | Automated, Manual<br>Immunoassay, other<br>(except EMIT ethosuximide) | Automated, Manual<br>Immunoassay, other |
| Base Matrix | Human Serum | Human Serum |
| Preservative | Non-Azide (proprietary) | Non-Azide (proprietary) |
| Calibration | Gravimetric & Traceable | Gravimetric + Some,<br>Traceable |
| Use | Verification of Calibration,<br>Linear Operating Range (OR),<br>Reportable Range<br>All Methods<br>(except EMIT ethosuximide) | Verification of Calibration,<br>Linear Operating Range (OR),<br>Reportable Range<br>All Methods |

Technical Characteristics by Assessment of Performance: The performance of AC/AD Verifiers has been tested on three commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System, Dade-Behring (formerly Syva) EMIT system, and Roche-Boehringer CEDIA reagents), by two colorimetric methods (GED reagents for acetaminophen and Sigma Diagnostic reagents for salicylate) and by HPLC (for nordiazepam) to validate their use. Most methods tested demonstrated the desired functionality of the product. Carbamazepine by fluorescence polarization immunoassay demonstrated a significant miscallbration believed to be real. GED reagents for acetaminophen gave results which might indicate incompatibility with AC/AD vertfiers. However, the GED reagents gave a level-correlated, proportional colorimetric response with the verifiers, and it was not possible to rule out a miscalibration. EMIT reagents for ethosuximide reacted with an interferent in the AC/AD base matrix, and this product is not useful with the EMIT ethosuximide reagents.

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Based upon the purpose of the device, the descriptions and label-Conclusions: ing of the predicate device, and upon the safety and efficacy using multiple instruments and methods, and stability data generated for the AC/AD Linearity Verifiers, the product is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three curved lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

## 2 1898 JUL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SC Calibrators & Controls LLC C/O Ms. Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K982217 Trade Name: AC/ADTH Linearity Verifiers Requlatory Class: I Product Code: DIF Dated: June 23, 1998 Received: June 24, 1998

Dear Ms. Stamp:

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 (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). 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "[e-mail]".

Sincerely yours.

Steven Sutman

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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Page

510 (k) NUMBER (if KNOWN) : _

DEVICE NAME: AC/AD Linearity Verifiers

Indications for Use of the Subject Device: AC/AD Linearity Verifiers should be used any time it is necessary to confirm the proper callbration and linear operating range of TDM methods and instruments. Quality control/verification requirements should be determined in conformance with local, state and/or Federal regulations or accreditation requirements

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON-ANOTHER PAGE ... IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over - The - Counter - Use (Optional Format 1-2-96)

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