PROSTATE SPECIFIC ANTIGEN CONTROL

K973099 · Dade Chemistry Systems, Inc. · JJX · Sep 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973099
• Device Name: PROSTATE SPECIFIC ANTIGEN CONTROL
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

PSA Control is intended to be used as an assayed quality control product for the PSA Methods for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module and the aca® plus immunoassay system.

Device Story

PSA Control is a frozen, assayed quality control product used in clinical laboratory settings to monitor the performance of PSA immunoassay methods. The product consists of human PSA-ACT in a bovine serum albumin (BSA) base, provided in twelve 5 mL vials across two levels. It is intended for use by laboratory professionals operating the Dimension® RxL clinical chemistry system or the aca® plus immunoassay system. By providing a known control sample, the device allows clinicians to verify the accuracy and precision of PSA assay results, ensuring reliable diagnostic information for patient monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Frozen product containing human PSA-ACT in bovine serum albumin (BSA) base. Provided in 5 mL vials at two levels. Designed for use with Dimension® RxL and aca® plus immunoassay systems.

Indications for Use

Indicated for use as an in vitro diagnostic quality control product for Prostate Specific Antigen (PSA) methods on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogeneous immunoassay module.

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

• aca® plus Prostate Specific Antigen Control

Submission Summary (Full Text)

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

SEP 2 9 1997

Chemistry Systems P.O. Box 6101

Newark, DE 19714

Image /page/0/Picture/1 description: The image shows the number K973099 in black font. Below the number is a black rectangle with the words DADE INTERNATIONAL in white font. The words are stacked on top of each other.

## Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Rebecca S. Ayash<br>Dade International Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 8/15/97 |
| Device Name: | Prostate Specific Antigen (PSA) Control |
| Classification Name: | Control, Single (Specified) Analyte Controls<br>(Assayed and Unassayed) |
| Predicate Device: | aca® plus Prostate Specific Antigen Control |

Device Description: PSA Control is a frozen product containing human PSA-ACT in a bovine serum albumin base. The kit consists of twelve vials, six at each of two levels, containing 5 mL each.

Intended Use: PSA Control is intended to be used as an assayed quality control product for the PSA Methods for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module and the aca® plus immunoassay system.

## Comparison to Predicate Device:

| | Dimension® RxL PSA Control | aca® plus PSA Control |
|--------------|----------------------------|-----------------------|
| Intended Use | Control | Control |
| Analyte | PSA-ACT | PSA-ACT |
| Matrix | BSA | BSA |
| Form | frozen | liquid |
| Volume | 5.0 mL per vial | 5.0 mL per vial |
| Levels | 2 levels | 2 levels |

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

## Comments on Substantial

Equivalence: PSA Control is the aca® plus PSA Control with the expanded intended use for the Dimension® RxL clinical chemistry system and with a recommended storage temperature of -10 to -20°C. Both the PSA Control for the Dimension® RxL system and the aca® plus PSA Control are manufactured using the same matrix and contain PSA-ACT as the analyte source. Both products are intended to be used as controls for prostate specific antigen assays.

Conclusion: PSA Control for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Control based on the companson summarized above.

Rebecca S. Ayersh

Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 8/15/97

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Requlatory Affairs and Compliance Manager

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a group of people.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 9 1997

Newark, DE 19714-6101 Re: K973099 Trade Name: Prostate Specific Antigen (PSA) Control Requlatory Class: I Product Code: JJX Dated: August 15, 1997 Received: August 19, 1997

Dear Ms. Ayash:

Rebecca S. Ayash

P.O. Box 6101

Dade International Inc. Building 500, mailbox 514

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 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 requirement, 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 requlations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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

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

25/97

## Indications Statement

Device Name: Prostate Specific Antigen (PSA) Control

Indications for Use: The PSA Control is an in vitro diagnostic product intended to be used as a quality control product for the Prostate Specific Antigen (PSA) method on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogeneous immunoassay module.

Rebecca S. Ayash

ebecca S. Ava Requiatory Affairs and Compliance Manager Date: 9/25/97

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 973099

510(k) Number

Peter E. Martini

Division Sign-Off Office of Device Evaluation

Preayston ke - ✓