ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05

K984073 · Bio-Rad · JJX · Nov 25, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984073
• Device Name: ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Architect Total ß-hCG MasterCheck is a multi-level liquid control product used in clinical laboratory settings. It consists of a Level 0 (HEPES buffer with bovine protein) and Levels 1-4 (human ß-hCG in HEPES buffer with bovine protein and antimicrobial agents). The device is used by laboratory technicians to verify the performance of the Abbott Architect i System, specifically for sensitivity, calibration linearity, and reportable range. By running these assayed controls, the user compares the system's output against expected values to ensure the analyzer is functioning within specifications. This verification process supports accurate clinical decision-making by ensuring the reliability of patient ß-hCG test results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control product; contains HEPES buffer, bovine protein stabilizers, and antimicrobial agents. Levels 1-4 contain human ß-hCG. Storage at 2-8°C. Open vial stability of 3 days at 2-8°C.

Indications for Use

Indicated for in vitro diagnostic use to verify sensitivity, calibration linearity, and reportable range of the Total ß-hCG 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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Image /page/0/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 in white text on a black background. The text is in a bold, sans-serif font. The logo is simple and recognizable.

Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: [phone]

JC984073

NOV 25 1998

# 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 Total ß-hCG 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 ArchitectTotal ß-hCG 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/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is in white, bold, sans-serif font. The text is set against a black, rounded rectangle.

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

Description of the Device

Architect Total ß-hCG MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.

Architect Total ß-hCG MasterCheck Levels 1, 2, 3 and 4 contain ß-hCG (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 Total ß-hCG MasterCheck and the devices to which substantial equivalence is claimed.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 25 1998

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

Re: K984073

> Trade Name: Architect Total β-hCG MasterCheck Requlatory Class: I Product Code: 75 JJX Dated: November 10, 1998 November 16, 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 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 requlatory 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 Butman

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 Total β-hCG MasterCheck

Indications for Use:

Architect Total ß-hCG 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 | K984013 |

| Prescription Use | OR Over-The Counter Use |
|------------------|-------------------------|
|------------------|-------------------------|