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.

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.

AI/ML Overview

This is a submission for a medical device called NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1), an in vitro diagnostic immunohistochemical (IHC) assay. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence to a predicate device, as opposed to a standalone performance study with predefined numerical metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device. The "device performance" is then the evidence presented to support this claim.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Device's intended use is the same or very similar to predicate.	Subject Device: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is an 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. Predicate Device: Ventana ER Primary Antibody (Clone 6F11) is intended for laboratory use for the qualitative detection of ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. (The intended uses are functionally equivalent.)
Target Epitope: Binds to the same biological target.	Subject Device: Estrogen Receptor Predicate Device: Estrogen Receptor
Matrix: Used with the same sample type.	Subject Device: Tissue (Breast) Predicate Device: Tissue (Breast)
Storage: Similar storage conditions.	Subject Device: 2°C to 8°C until expiration date Predicate Device: 2°C to 8°C until expiration date
Stability: Similar stability profile.	Subject Device: Until expiration date noted on package Predicate Device: Until expiration date noted on package
Technological Characteristics: Does not raise new questions of safety or effectiveness.	The main difference is the Clone: Subject device uses Rabbit Monoclonal Ab (Clone SP1), while the predicate uses Murine Monoclonal Ab (Clone 6F11). The submission implies that this difference does not raise new safety/effectiveness concerns, as substantial equivalence was granted.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a separate "test set" with a particular sample size or data provenance (e.g., country of origin, retrospective/prospective). This submission relies on demonstrating substantial equivalence to a predicate device primarily through comparison of intended use and physical properties, rather than a new clinical performance study with a dedicated test set designed to establish quantitative performance metrics like sensitivity, specificity, or AUC.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As there is no mention of a traditional "test set" and a study to establish performance against a ground truth, this information is not applicable and not provided in the document. The submission focuses on comparing the new device's characteristics against a cleared predicate.

4. Adjudication Method for the Test Set

Since there is no described test set with human observer interpretations and ground truth, an adjudication method is not described or applicable in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission does not describe any study involving human readers or comparing their performance with or without AI assistance. This device is an antibody for immunohistochemistry, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone performance study (algorithm only) was not done. This is an in vitro diagnostic antibody, not an algorithm or software. Its performance is demonstrated by its inherent binding characteristics and consistency with the predicate device.

7. The Type of Ground Truth Used

The term "ground truth" in the traditional sense of a clinical benchmark for diagnostic accuracy is not directly used or established in this submission. The "truth" for this 510(k) is the established performance and safety of the predicate device. The claim of substantial equivalence relies on the new device having similar characteristics and intended use to the predicate, assuming the predicate itself is safe and effective. The intrinsic validation of the antibody's binding to ER in tissues serves as the basis for its function, but this isn't detailed as a specific "ground truth" study in this document for 510(k purposes.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This device is an antibody, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided in the document. As this is an antibody, there is no "training set" in the context of machine learning.

Summary

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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: (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:

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:

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-Human ER Antibody (Clone SP1) isan immunohistochemical (IHC) assayintended for laboratory use for thequalitative detection of ER antigen bylight microscopy in sections offormalin fixed, paraffin embeddednormal and neoplastic tissues on aLab Vision automated slide stainer. Itis indicated as an aid in assessing thelikelihood of response to therapy aswell as in the prognosis andmanagement of breast cancer patients.	Ventana ER Primary Antibody (Clone6F11) is intended for laboratory usefor the qualitative detection of ERantigen in sections of formalin fixed,paraffin embedded tissue of a Ventanaautomated immunohistochemistryslide staining device. It is indicated asan aid in the management, prognosisand prediction of therapy outcome ofbreast 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 onpackage

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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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is facing to the left. The logo is surrounded by text that reads "U.S. Department of Health and Human Services" in a circular arrangement.

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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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 ne (800) 638-2041 or (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1

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

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.