(42 days)
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.
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.
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.
§ 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.