ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05

K984325 · Bio-Rad · JJY · Dec 17, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984325
• Device Name: ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Architect Ferritin MasterCheck is a liquid, multi-level control product used in clinical laboratory settings to verify the performance of the Ferritin assay on the Abbott Architect i System. The device consists of five levels (Level 0-4); Level 0 contains HEPES buffer with bovine protein stabilizers, while Levels 1-4 contain human-derived ferritin in the same buffer matrix with antimicrobial preservatives. Laboratory technicians use the product to assess calibration linearity, sensitivity, and reportable range. By comparing the measured values of the MasterCheck against expected ranges, clinicians verify the accuracy and reliability of the Ferritin assay, ensuring consistent diagnostic results for patient ferritin levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid control; matrix: HEPES buffer with bovine protein stabilizers; contains human-derived ferritin (Levels 1-4); antimicrobial preservative; storage 2-8°C; open vial stability 3 days at 2-8°C.

Indications for Use

Indicated for use as an in vitro diagnostic control to verify sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.

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 (K950469)

Submission Summary (Full Text)

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K984325

DEC 1 7 1998

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Bio-Rad Laboratories

Diagnostics Group 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 December 02, 1998

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

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### Description of the Device

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

Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (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 similanties between the Bio-Rad Architect Ferritin MasterCheck and the devices to which substantial equivalence is claimed.

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

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 1 7 1998 Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K984325 Architect Ferritin MasterCheck Trade Name: Regulatory Class: I Product Code: JJY Dated: December 2, 1998 Received: December 3, 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 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 qeneral 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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation 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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Page 1 of 1

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

Indications for Use:

Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay 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) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984315 |

| Prescription Use | <div> <span></span> </div> | OR | Over-The Counter Use | <div> <span></span> </div> |
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