VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16

K062615 · Vision Biosystems, Inc. · MXZ · Jan 29, 2007 · Hematology

Device Facts

• Record ID: K062615
• Device Name: VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
• Applicant: Vision Biosystems, Inc.
• Product Code: MXZ · Hematology
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.

Device Story

PGR Clone 16 is a mouse monoclonal antibody designed for immunohistochemistry (IHC) staining. It targets the progesterone receptor (PGR) antigen located in the nuclei of normal and neoplastic cells. The device is used in a laboratory setting by trained personnel. It is applied to formalin-fixed, paraffin-embedded tissue sections. The antibody binds to the PGR antigen, which is then visualized via light microscopy. The resulting staining pattern is interpreted by a qualified pathologist in conjunction with morphological studies, patient clinical history, and other diagnostic tests. This information assists clinicians in the management, prognosis, and therapy prediction for breast cancer patients. The device is available in various formats, including lyophilized, liquid, and ready-to-use configurations, optimized for manual use or specific automated staining systems (Ventana NexES/BenchMark or Vision BioSystems Bond-max).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mouse monoclonal antibody; immunohistochemistry reagent. Formats: lyophilized, liquid, and ready-to-use. Compatible with manual staining or automated systems (Ventana NexES/BenchMark, Bond-max). Principle: specific binding to nuclear PGR antigen followed by light microscopy visualization. Class II device (21 CFR 864.1860).

Indications for Use

Indicated for the qualitative identification of progesterone receptor (PGR) antigen in formalin-fixed, paraffin-embedded breast tissue sections to aid in the management, prognosis, and prediction of therapy outcome for breast cancer patients. Intended for use by qualified pathologists.

Regulatory Classification

Identification

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Special Controls

(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.

Predicate Devices

• Dako Mouse Anti-Human Progesterone Receptor Clone PgR 636 (K020023)

Submission Summary (Full Text)

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

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

JAN 2 9 2007

+

-

## 510(k) SUMMARY

and the comments of the comments of the comments of the comments of

and the comments of the comments of

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the fir

:

and the comments of the comments of

.

:

| Date Prepared | August 25, 2006 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Submitter | Vision BioSystems, Inc.<br>1833 Portola Rd.<br>Ventura, CA 93003 |
| Contact | Ron Lagerquist<br>Director, Regulatory Affairs |
| Device Name | Vision BioSystems Progesterone Receptor Clone 16 |
| Common/Usual/<br>Classification Name | Progesterone Receptor<br>Immunohistochemistry Reagents and Kits |
| Device Description | PGR Clone 16 is a monoclonal mouse antibody that<br>detects a human progesterone receptor epitope<br>located in the nucleus of PGR positive cells. |
| Intended Use | PGR Clone 16 is intended for <i>in vitro</i> diagnostic use<br>for the qualitative detection of progesterone receptor<br>in formalin-fixed paraffin embedded tissues. PGR<br>Clone 16 is indicated as an aid in the management,<br>prognosis and prediction of therapy outcome of<br>breast cancer within the context of the patient's<br>clinical history and other diagnostic tests evaluated<br>by a qualified pathologist. |
| Substantial Equivalence | PGR Clone 16 is substantially equivalent to DAKO<br>Corporation Mouse Monoclonal Progesterone<br>Receptor PgR 636 |

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 9 2007

Re: k062615

VISION Biosystems Inc.

C/O Ronald F. Lagerquist

Ventura, California 93003

1833 Portola Road

Trade/Device Name: Vision BioSystems Progesterone Receptor Clone 16 Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: Class II Product Code: MXZ Dated: August 25, 2006 Received: September 5, 2006

Dear Mr. Lagerquist:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.

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

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Rafa Becker/

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Page 3 -

. . . . . .

:

:

## cc: HFZ-401 DMC

:

HFZ-404 510(k) Staff HFZ- 440 Division

and the comments of the comments of

:

11 - 11 - 11 - 11

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

## Indications for Use

510(k) Number k062615

Device Name:

Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone16)

- Novocastra™ Lyophilized Mouse Monoclonal Antibody .
- Novocastra™ Liquid Mouse Monoclonal Antibody
- Novocastra™ Ready-to-Use Primary Antibody .
- Origin™ Ready-to-Use Primary Antibody
- Bond™ Ready-to-Use Primary Antibody

Indications for Use:

Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.

PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.

Prescription Use

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

PAGE IF NEEDED)

Division Sigh-Off Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062615