NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

K061360 · Lab Vision Corp. · MYA · Jun 27, 2006 · Hematology

Device Facts

• Record ID: K061360
• Device Name: NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
• Applicant: Lab Vision Corp.
• Product Code: MYA · Hematology
• Decision Date: Jun 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

Neomarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of estrogen receptor (ER) antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer.

Device Story

Rabbit monoclonal antibody (Clone SP1) immunohistochemical assay; identifies estrogen receptor (ER) expression in formalin-fixed, paraffin-embedded breast tissue. Used in clinical laboratories; operated by technicians/pathologists on Lab Vision automated slide stainer. Principle: antibody binds nuclear ER antigen; localized via biotin-conjugated secondary antibody and avidin/streptavidin enzyme conjugate; visualized via precipitating enzyme reaction product under light microscopy. Pathologist evaluates staining intensity and distribution to determine ER status. Output aids clinical decision-making regarding breast cancer therapy response and prognosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparison of intended use and physical properties to the predicate device.

Technological Characteristics

Immunohistochemical assay; rabbit monoclonal antibody (Clone SP1). Ready-to-use (approx. 1.6 µg/mL) or concentrate (approx. 160 µg/mL) formulations in Tris-HCL buffer with sodium azide preservative. Automated staining via Lab Vision Autostainer. Detection via biotin-conjugated secondary antibody and avidin/streptavidin enzyme conjugate.

Indications for Use

Indicated for qualitative detection of estrogen receptor (ER) antigen in formalin-fixed, paraffin-embedded normal and neoplastic breast tissue sections. Used as an aid in assessing therapy response likelihood, prognosis, and management of breast cancer patients.

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

• Ventana ER Primary Antibody (Clone 6F11) (K984567)

Submission Summary (Full Text)

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K061360

# SECTION II

JUN 2 7 2006

# 510(k) SUMMARY

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

#### 510(k) Number:

#### Submitter:

Lab Vision Corporation 47777 Warm Springs Blvd. Fremont, CA 94539 Telephone: [phone] Facsimile: [phone]

#### Contact Person:

Grace Hsiao-Fen Chang Manager, Regulatory Affairs Telephone: [phone] Facsimile: [phone]

#### Preparation Date:

May 11, 2006

#### Device Information:

| Device Classification Name: | Immunohistochemistry Assay, Antibody, Estrogen Receptor |
|-----------------------------|--------------------------------------------------------------------------------|
| Common/Usual Name: | Antibody for detection of estrogen receptor in histological tissue sections |
| Proprietary Name: | NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP1) |
| Regulation Number: | 21 CFR§864.1860 |
| Product Code: | MYA |
| Regulatory Class: | Class II |

#### Predicate Devices:

NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11) (K984567) for its stated intended use.

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#### Device Description:

Lab Vision's NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor (ER) Antibody (Clone SP1) binds to ER in the paraffin embedded tissue section. The specific antibody is localized by a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins. This step is followed by the addition of an avidin/streptavidin enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody secondary antibody avidin/streptavidin enzyme complex is then visualized with a precipitating enzyme reaction product, which is readily detected by light microscopy. Each step is incubated for a precise time and at room temperature. At the end of each incubation step, the Lab Vision automated slide stainer (Lab Vision Autostainer) washes the sections to stop the reaction and remove unbound material that would interfere the desired reaction in subsequent steps.

#### Intended Use:

NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

### Comparison to Predicate Device(s);

NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11) (K984567) for its stated intended use.

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| Device | Subject Device | Predicate Device |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | (K984567) (K990618) |
| Intended Use | NeoMarkers Rabbit Monoclonal Anti-<br>Human ER Antibody (Clone SP1) is<br>an immunohistochemical (IHC) assay<br>intended for laboratory use for the<br>qualitative detection of ER antigen by<br>light microscopy in sections of<br>formalin fixed, paraffin embedded<br>normal and neoplastic tissues on a<br>Lab Vision automated slide stainer. It<br>is indicated as an aid in assessing the<br>likelihood of response to therapy as<br>well as in the prognosis and<br>management of breast cancer patients. | Ventana ER Primary Antibody (Clone<br>6F11) is intended for laboratory use<br>for the qualitative detection of ER<br>antigen in sections of formalin fixed,<br>paraffin embedded tissue of a Ventana<br>automated immunohistochemistry<br>slide staining device. It is indicated as<br>an aid in the management, prognosis<br>and prediction of therapy outcome of<br>breast cancer. |
| Target Epitop | Estrogen Receptor | Estrogen Receptor |
| Clone | Rabbit Monoclonal Ab (Clone SP1) | Murine Monoclonal Ab (Clone 6F11) |
| Matrix | Tissue (Breast) | Tissue (Breast) |
| Storage | 2℃ to 8℃ until expiration date | 2℃ to 8℃ until expiration date |
| Stability | Until expiration date noted package | Until expiration date noted on<br>package |

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### Summary:

The information provided in this pre-market notification demonstrates that NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11), the previously cleared predicate device (K984567). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is safe and effective for it's stated intended use.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Grace Hsiao-Fen Chang Manager, Regulatory Affairs Lab Vision Corporation 47777 Warm Springs Boulevard Fremont, California 94539

JUN 27 2006

Re: k061360 Trade/Device Name: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SPI) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Regulatory Class: II Product Code: MYA Dated: May 11, 2006 Received: May 16, 2006

Dear Ms. Chang:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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 ne [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobetz Beckerh

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

Enclosure

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### SECTION III

## INDICATIONS FOR USE STATEMENT

#### KOOLBOO 510(k) Number (if known):

Device name: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1).

#### Indications for Use:

NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

### PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1

OR

Over-the Counter Use

(per 21 CFR §801.109)

(Optional Format 1-2-96)

Division Sigh-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(k) K06136C