Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra

{0} SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION MEMORANDUM 510(k) Number: K183100 This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable: 1. The name and 510(k) number of the applicant’s previously cleared device. K122556 Estrogen Receptor Clone 6F11 (ER 6F11) - Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™; - Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ 2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for - Replacement of the slide staining assembly (SSA) printed wiring assembly (PWA) and its associated embedded firmware due to microprocessor obsolescence, - BOND software update from version 5.1 to 6.0. No changes have been made to the BOND IHC F protocol that is used on the BOND-III instrument and no change has been made to the reagent for the Estrogen Receptor Clone 6F11 (ER 6F11) assay. The BOND IHC F protocol has been verified to remain consistent by (a) not changing the data supplied to the BOND Application and (b) showing that the data passed to the instrument remains identical to that under the previous approved software releases versions 4.1, 5.0 and 5.1. Verification and validation activities are performed for every change to Leica Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) and the BOND-III instrument. The verification and validation procedures, methods and acceptance criteria for product changes remain the same as those performed for and described in the predicate device, K122556. {1} 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including device name, intended use, physical characteristics, quality control and antibody manufacturing, labeling as well as software, are in the table below. | Item | K183100 (Subject Device) | K122556 (Predicate Device) | | --- | --- | --- | | Device Name | Estrogen Receptor Clone 6F11 (ER 6F11) • Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™; • Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ | Same | | Intended Use / Indications for Use | Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Estrogen Receptor Clone 6F11 is indicated as an aid in the management, prognosis and predication 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. Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ and the Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit. | Same | | RTU Reagent | Estrogen Receptor Clone 6F11 is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative. Total Volume = 7 mL (PA0151); 30 mL (PA0009) Total Protein Concentration: Approx 10 mg/mL Antibody Concentration: ≥ 0.88 mg/L as determined by ELISA | Same | {2} | Concentrated AB Reagent | Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ is a liquid tissue culture supernatant containing sodium azide as a preservative. Total Protein Concentration: Batch Specific | Same | | --- | --- | --- | | Clone, Immunogen, Specificity, Subclass (both formats) | Clone: 6F11 Immunogen: Prokaryotic recombinant protein corresponding to the full-length alpha form of the human estrogen receptor molecule Specificity: Human estrogen receptor Subclass: IgG1 | Same | | Technology | Immunohistochemistry | Same | | Tissue Type | formalin-fixed, paraffin-embedded breast cancer tissue | Same | | Staining Pattern | Nuclear | Same | | Platform | BOND-III | Same | | Staining Protocol | BOND IHC F | Same | | Slide Staining Assembly (SSA) Printed Wiring Assembly (PWA) | Replacement of the SSA PWA and its associated embedded firmware due to microprocessor obsolescence | Original SSA / PWA | | BOND Software | Version 6.0 | Version 5.1 | 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied Risk assessments for the SSA PWA changes and BOND software v5.1 to v6.0 changes were performed to assess the impact of the modifications on the device by identifying risks, their possible causes, and appropriate control mechanisms. The Risk Analyses took into account device hazards associated with the intended use of the device. No additional hazards, no additional causes, and no {3} required additional controls were identified. No adverse events or reportable incidents have been associated with the device. The following studies were performed to verify and validate for the SSA PWA changes: - Staining Verification and Validation - EMC Testing - Overall Hardware and Software Verification - Hardware Progression Verification - Firmware Progression Verification - System Integration Verification - System Regression Verification - Upgrade Utility Verification The following studies were performed to verify and validate for the update of BOND software from v5.1 to v6.0: - Staining Verification and Validation - Software Verification For each test, acceptance criteria were identified and observed results were compared to expected results. All acceptance criteria were met and all tests passed. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. 4