NOT · Microscope, Automated, Image Analysis, Operator Intervention
Hematology · 21 CFR 864.1860 · Class 2
Overview
| Product Code | NOT |
|---|---|
| Device Name | Microscope, Automated, Image Analysis, Operator Intervention |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | Leica Biosystems Imaging, Inc. | Jul 29, 2014 | SESE |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | Sep 6, 2013 | SESE |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | Ventana Medical Systems, Inc. | Jun 1, 2012 | SESE |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | Feb 22, 2012 | SESE |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | Oct 12, 2011 | SESE |
| K080564 | SCANSCOPE XT SYSTEM | Aperio Technologies | Aug 14, 2009 | SESE |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | Bioimagene, Inc. | Feb 4, 2009 | SESE |
| K071128 | SCANSCOPE XT SYSTEM | Aperio Technologies | Oct 10, 2007 | SESE |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | Bioimagene, Inc. | Feb 20, 2007 | SESE |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | Tripath Imaging, Inc. | Aug 16, 2005 | SESE |
| K031715 | ARIOL HER-2/NEU IHC | Applied Imaging Corp. | Jan 8, 2004 | SESE |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | Dec 23, 2003 | SESE |
Top Applicants
- Ventana Medical Systems, Inc. — 4 clearances
- Aperio Technologies — 2 clearances
- Bioimagene, Inc. — 2 clearances
- Applied Imaging Corp. — 1 clearance
- Chroma Vision Medical Systems, Inc. — 1 clearance
