NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Hematology · 21 CFR 864.1860 · Class 2
Overview
| Product Code | NQN |
|---|---|
| Device Name | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity |
| Regulation | 21 CFR 864.1860 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
(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. (2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). (3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
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.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Applied Spectral Imaging , Ltd. | Jan 15, 2015 | SESE |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | Mar 20, 2014 | SESE |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Ventana Medical Systems, Inc. | Nov 22, 2013 | SESE |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | Sep 26, 2013 | SESE |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | Sep 19, 2013 | SESE |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Ventana Medical Systems, Inc. | Apr 19, 2012 | SESE |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Ventana Medical Systems, Inc. | Mar 5, 2012 | SESE |
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Bioimagene, Inc. | Oct 27, 2010 | SESE |
| K073677 | SCANSCOPE XT SYSTEM | Aperio Technologies | Aug 1, 2008 | SESE |
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | Tripath Imaging | Jan 10, 2007 | SESE |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Tripath Imaging, Inc. | Sep 29, 2006 | SESE |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Tripath Imaging, Inc. | Apr 11, 2006 | SESE |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | Tripath Imaging, Inc. | May 6, 2005 | SESE |
| K033200 | ARIOL | Applied Imaging Corp. | Mar 18, 2004 | SESE |
| K031363 | QCA (VERSION 3.1) | Cell Analysis, Inc. | Feb 5, 2004 | SESE |
Top Applicants
- Ventana Medical Systems, Inc. — 6 clearances
- Tripath Imaging, Inc. — 3 clearances
- Aperio Technologies — 1 clearance
- Applied Imaging Corp. — 1 clearance
- Applied Spectral Imaging , Ltd. — 1 clearance
