ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05

K990393 · Bio-Rad · JJX · Mar 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990393
• Device Name: ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Architect Progesterone MasterCheck is a multi-level control product consisting of human serum (Level 0) and human serum spiked with progesterone (Levels 1-4). It is used in clinical laboratory settings to verify the performance of the Abbott Architect i System progesterone assay, specifically assessing sensitivity, calibration linearity, and reportable range. The device is a liquid, ready-to-use control. Laboratory personnel use the product to ensure the accuracy and reliability of the assay system. By comparing the measured values of the MasterCheck levels against expected ranges, clinicians can validate that the assay is performing within specifications, thereby supporting accurate diagnostic decision-making for patients requiring progesterone testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid, human serum-based control. Contains progesterone (Levels 1-4) and antimicrobial preservative. Storage at 2-8°C. Designed for use with the Abbott Architect i System. No specific ASTM standards or software algorithms mentioned.

Indications for Use

Indicated for use in clinical laboratories to verify the sensitivity, calibration linearity, and reportable range of the Progesterone 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a handwritten date, "8/22/99", in black ink. Below the date, there is a faded, illegible stamp or marking, which appears as a blurred, textured area. The date is written with a slightly slanted style, and the stamp is positioned directly beneath it.

K920393

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 February 8, 1999

Device (Trade & Common Name) Architect Progesterone MasterCheck

Classification Name Class I, 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 Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image is a black and white photograph that appears to be a landscape. The bottom portion of the image contains a series of dark, irregular shapes that could be interpreted as trees or bushes. The upper portion of the image is mostly white, suggesting a sky or a bright, featureless background.

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

Description of the Device Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum.

Preservative: Antimicrobial Agent.

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Abbott Architect Progesterone MasterCheck and the devices to which substantial equivalence is claimed.

| | Architect Progesterone<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 of the<br>Progesterone assay 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 | Human Serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Progesterone | Multiple |
| Open Vial<br>Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the<br>Architect Progesterone assay. | Calibration verifier for<br>multiple analytes. |

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

MAR 2 2 1994

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K990393 Trade Name: Architect Progesterone MasterCheck Regulatory Class: I Product Code: JJX Dated: February 8, 1999 February 9, 1999 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, Druq, 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 regulations.

{3}------------------------------------------------

Page 2

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 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

{4}------------------------------------------------

Page 1 of 1

510(k) Number: __ K990 393 Device Name: Architect Progesterone MasterCheck

Indications for Use:

Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone 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 | K990393 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The Counter Use |
|------------------|-----------------------------------------|----|----------------------|
|------------------|-----------------------------------------|----|----------------------|

29