ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05

K984319 · Bio-Rad · JJX · Dec 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984319
• Device Name: ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.

Device Story

Architect Free T3 MasterCheck is a multi-level liquid control product consisting of human serum; Level 0 contains human serum; Levels 1, 2, and 3 contain Free T3 prepared in human serum with sodium azide preservative. The device is used in clinical laboratory settings to verify the performance of the Free T3 assay on the Abbott Architect i System. By testing these levels, laboratory personnel can verify the sensitivity, calibration linearity, and reportable range of the assay. This verification process ensures the accuracy and reliability of patient test results, assisting healthcare providers in making informed clinical decisions regarding thyroid function.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid form; human serum matrix; contains sodium azide preservative; stored at 2-8°C. Designed for use with the Abbott Architect i System. No specific ASTM standards or software algorithms described.

Indications for Use

Indicated for use as a calibration verification material for the Free T3 assay on the Abbott Architect i System to verify sensitivity, calibration linearity, and reportable range.

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

• Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME (K950469)

Submission Summary (Full Text)

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DEC 2 2 1998

K9843/9

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Bio-Rad Laboratories

A Jamnimo Road e, California 92618-2017 Telephone: [phone]

# 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 02, 1998

Device (Trade & Common Name) Architect Free T3 MasterCheck

Classification Name Class 1, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed),

Devices to Which Substantial Equivalence is Claimed

Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469

#### Statement of Intended Use

Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a simple, bold design that features the company name in white letters against a black background. The logo is easily recognizable and is used on a variety of Bio-Rad products and marketing materials.

Bio-Rad Laboratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

Description of the Device Architect Free T3 MasterCheck Level 0 contains human serum. Architect Free T3 MasterCheck Levels 1, 2 and 3 contain Free T3 prepared in human serum.

Preservative: Sodium Azide.

### Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Architect Free T3 MasterCheck and the devices to which substantial equivalence is claimed.

| | Architect Free T3 MasterCheck | Casco Standards Document<br>Serum Multi-Analyte<br>Verification Test Set |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Verification of sensitivity,<br>calibration linearity, and<br>reportable range of the Free T3<br>assay on the Abbott Architect i<br>System. | In vitro diagnostic use in the<br>quantitative determination of<br>linearity, calibration<br>verification and verification<br>of reportable range using<br>automated, semi-automated<br>and manual methods. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Free T3 | Multiple |
| Open Vial<br>Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the<br>Architect Free T3 assay | Calibration verifier for<br>multiple analytes. |

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DEC 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984319 Trade Name: Architect Free T3 MasterCheck Regulatory Class: I Product Code: JJX Dated: December 2, 1998 December 3, 1998 Received:

Dear Ms. Platt:

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 leqally 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 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 requlations.

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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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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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510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect Free T3 MasterCheck

Indications for Use:

Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.

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(Concurrence of CDRH, Office of Device Evaluation)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984319 |

| Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> |
|-------------------------|-------------------------------------------------------------------|
| OR Over-The Counter Use | |