ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05

K984072 · Bio-Rad · JJX · Nov 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984072
• Device Name: ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Architect TSH MasterCheck is an in vitro diagnostic control product used to verify the performance of the Abbott Architect i System. The device consists of a set of liquid controls (Level 0 containing TRIS buffer/bovine protein; Levels 1-4 containing human TSH in TRIS buffer/bovine protein). It is used by laboratory personnel to assess calibration linearity, sensitivity, and the reportable range of the TSH assay on the Architect i System. By comparing the system's measured values against the expected values of the MasterCheck, clinicians verify that the analyzer is operating within specifications, ensuring accurate patient test results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control product. Matrix: TRIS buffer with bovine protein stabilizers. Preservative: Sodium Azide. Storage: 2-8°C. Open vial stability: 3 days at 2-8°C. Analyte: TSH (human).

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 Serum Multi-Analyte Verification Test Set (K950469)

Submission Summary (Full Text)

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NOV 2 5 1998

Image /page/0/Picture/1 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 displayed in white text on a black, rounded rectangular background. The text "BIO-RAD" is written in a bold, sans-serif font, with a plus sign between "BIO" and "RAD".

Bio-Rad Laboratories 9500 Jeronimo Road Irvine, 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 November 10, 1998

Device (Trade & Common Name) Architect TSH 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 TSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System

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Image /page/1/Picture/3 description: The image shows the logo for BIO-RAD. The logo is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.

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

## Description of the Device

Architect TSH MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.

Architect TSH MasterCheck Levels 1, 2, 3 and 4 contain TSH (human) prepared in TRIS buffer with protein (bovine) stabilizers.

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 TSH MasterCheck and the devices to which substantial equivalence is claimed.

| | Architect TSH 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 on the<br>Abbott Architect i 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 | TRIS buffer with protein<br>(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | TSH | Multiple |
| Open Vial<br>Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the<br>Architect TSH assay | Calibration verifier for<br>multiple analytes. |

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized human figure with three arms or extensions reaching upwards. The text is arranged in a circular fashion around the symbol.

NOV 25 J

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: K984072 Trade Name: Architect TSH MasterCheck Regulatory Class: I Product Code: 75 JJX Dated: November 10, 1998 Received: November 16, 1998

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 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 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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Paqe 2

This letter will allow you to beqin 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 diaqnostic 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 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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Page 1 of 1

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect TSH MasterCheck

Indications for Use:

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

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

(Concurrence of CDRH, Office of Device Evaluation)

| | (Division Sign-Off)<br>Division of Clinical Laboratory Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | K984072 |

| Prescription Use | OR Over-The Counter Use |
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