NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR 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.

Device Description

Immunohistochemistry Assay, Antibody, Progesterone Receptor. Antibody for detection of progesterone receptor in histological tissue sections. NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for a medical device called "NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2)".

The document focuses on:

Device Identification: Name, classification, regulation number, product code, and regulatory class.
Submission Details: Submitter information, contact person, and preparation date.
FDA Correspondence: A letter from the FDA indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Indications for Use: The intended purpose of the device, which is an immunohistochemical (IHC) assay for the qualitative detection of Progesterone Receptor (PR) in formalin-fixed, paraffin-embedded tissues. This assay is intended as an aid in assessing response likelihood to therapy, prognosis, and management of breast cancer patients.

Therefore, I cannot provide the requested table and information, as the input does not describe a study with acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness.

Summary

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K060462

SECTION II

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: (510) 991-2800 Facsimile: (510) 991-2826

Contact Person:

Grace Hsiao-Fen Chang Manager, Regulatory Affairs Telephone: (510) 991-2854 Facsimile: (510) 991-2826

Preparation Date:

February 21, 2006

Device Information:

Device Classification Name:	Immunohistochemistry Assay, Antibody, Progesterone Receptor.
Common/Usual Name:	Antibody for detection of progesterone receptor in histological tissue sections
Proprietary Name:	NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)
Regulation Number:	21 CFR§864.1860
Product Code:	MXZ (for Progesterone Receptor antibody)
Regulatory Class:	Class II

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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 consists of a stylized caduceus, which is a symbol of medicine, with three horizontal bars above it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the caduceus.

Public Health Service

ood and Drug Administratio 2098 Gaither Boad Rockville MD 20850

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

2011 2 4 2005

Re: K060462

Trade/Device Name: NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: MXZ Dated: February 21, 2006 Received: February 23, 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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Robert Becker Jr

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

510(k) Number (if known): Ko (o (0402

Device name: NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2)

Indications for Use:

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060462

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

Over-the Counter Use___________

(per 21 CFR §801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.1860 Immunohistochemistry reagents and kits.

(a)
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.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(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.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.