ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05

K990608 · Bio-Rad · JJX · Mar 30, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990608
• Device Name: ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Architect CEA MasterCheck is a liquid control product used in clinical laboratory settings to verify the performance of the CEA assay on the Abbott Architect i System. The device consists of multiple levels (0-4) containing human CEA in a HEPES buffer with bovine protein stabilizers and antimicrobial agents. It is used by laboratory technicians to assess calibration linearity, sensitivity, and the reportable range of the assay. By comparing the measured values of the MasterCheck levels against expected values, the healthcare provider ensures the accuracy and reliability of patient test results, facilitating appropriate clinical decision-making for patients undergoing CEA monitoring.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid control material; contains human CEA, HEPES buffer, bovine protein stabilizers, and antimicrobial agents. Storage at 2-8°C. Designed for use on the Abbott Architect i System.

Indications for Use

Indicated for use as a calibration verification material for the CEA 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

• Document Serum Multi-Analyte Verification Test Set (K950469)

Submission Summary (Full Text)

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K 940608

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Bio-Rad Laboratories

500 Jeronimo F vine California 92618-20 elephone: (949) 598-12

## 510(k) Summary

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

Contact Person Elizabeth Platt

Date of Summary Preparation February 23, 1999

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

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

Description of the Device

Architect CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.

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

Preservative: Antimicrobial Agent.

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

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 300 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re: K990608 Trade Name: Architect™ CEA MasterCheck Regulatory Class: I Product Code: JJX Dated: February 23, 1999 Received: February 24, 1999

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

Sincerely yours.

Steven Putman

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 CEA MasterCheck

Indications for Use:

Architect CEA MasterCheck is intended for use in the verification of Arenitoot OEA Mactor Should Shourity, and reportable range of the CEA assay on the Abbott Architect i System.

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(Concurrence of CDRH, Office of Device Evaluation)

| | <div> <img alt="Signature" src="signature.png"/> </div> |
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| | (Division Sign-Off) |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990608 |

| Prescription Use | <img alt="Check Mark" src="check_mark.png"/> | OR Over-The Counter Use |
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