MODIFICATION TO DOCUMENT THYROID CAL.VER

K993014 · Casco-Nerl Diagnostics Corporation (Maine) · JJY · Nov 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993014
• Device Name: MODIFICATION TO DOCUMENT THYROID CAL.VER
• Applicant: Casco-Nerl Diagnostics Corporation (Maine)
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.

Device Story

DOCUMENT Thyroid CAL•VER consists of assayed serum-based solutions containing T4, T3, TSH, and Cortisol. Provided in 6 levels to establish linear relationships between theoretical and actual instrument performance. Used by clinical laboratory personnel to verify reportable ranges, perform calibration verification, and troubleshoot chemistry systems or reagent anomalies. Not intended for use as a primary calibrator or routine quality control material. Product supports regulatory compliance for periodic linearity studies.

Clinical Evidence

No clinical data. Bench testing only; product performance is established by comparing assayed values against instrument reportable ranges and theoretical linearity targets.

Technological Characteristics

Assayed serum-based solution containing T4, T3, TSH, and Cortisol. Provided in 6 levels, 5.0 mL per bottle. Shelf life of 12 months at -10 to -20°C. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to verify linearity, calibration, and reportable range for T4, T3, TSH, and Cortisol on immunochemistry and clinical chemistry systems.

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® Thyroid CAL•VER™ (K992034)

Submission Summary (Full Text)

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NOV 26 1999

# ATTACHMENT 2

# 510(k) SUMMARY

[Refer to 21 CFR \$807.92]

| | CASCO-NERL Diagnostics |
|----------------------|-----------------------------------------------------|
| Submitted by: | 500 Riverside Industrial Parkway |
| | Portland, ME 04103-1418<br>(207)-878-7550 |
| Contact Person: | Karen Hickey |
| Date Prepared: | September 7, 1999 |
| Proprietary Name: | DOCUMENT® Thyroid CAL•VER™ |
| Common Name: | Calibration Verification Quality Control Material |
| Classification Name: | Control, Multianalyte Assayed<br>(21 CFR §862.1660) |
| Predicate Device: | DOCUMENT® Thyroid CAL•VER™<br>510(k) #K992034 |

#### Description of the Device:

DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.

#### Intended Use of the Device:

DOCUMENT Thyroid CAL • VER contains assaved solutions for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4). Triodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol . This product is not intended for use as a calibration material on instrument systems or as a routine quality control material. ﻪ . . .

## Technological Characteristics:

Many inspection agencies require the documentation of periodic linearity, calibration verification of reportable range studies on procedures in the clinical laboratory, DOCUMENI® Thyroid CAL . VER will assist in this process when used as instructed. In addition, d Thyroid CAL . VER will provide valuable assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.

## Performance Characteristics and Data

DOCUMENT® Thyroid CAL • VER consists of 8 levels which cover the reportable range of instrumentation on the market. Targets cover the clinical reference range for the analytes present. This product has a 12-month shelf life at frozen temperatures (-10 to -20℃).

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 1999

Ms. Karen Hickey Director. Quality Assurance and Regulatory Affairs CASCO®NERL Diagnostics 500 Riverside Industrial Parkway Portland, Maine 04103-1418

Re: K993014

Trade Name: DOCUMENT Thyroid CAL VERTM Regulatory Class: I Product Code: JJY Dated: September 3, 1999 Received: September 8, 1999

Dear Ms. Hickey:

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 against 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 Regulations. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

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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# III. INDICTATIONS FOR USE STATEMENT

510(k) Number (if known): K_993014

Device name: DOCUMENT Thyroid CAL•VER™

Indications for Use:

DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Teta E. Mahini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K993014