K130021 is an FDA 510(k) clearance for the PHILIPS HERCEPTEST DIGITAL SCORE. This device is classified as a Automated Digital Image Manual Interpretation Microscope (Class II - Special Controls, product code OEO).
Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on September 19, 2013, 259 days after receiving the submission on January 3, 2013.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860. The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer..
| 510(k) Number | K130021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2013 |
| Decision Date | September 19, 2013 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | OEO — Automated Digital Image Manual Interpretation Microscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |
| Definition | The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer. |