| Device Type ID | 5015 |
| Device Name | Slide Stainer, Automated |
| Regulation Description | Automated Slide Stainer. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.3800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KPA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5015 |
| Device | Slide Stainer, Automated |
| Product Code | KPA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Automated Slide Stainer. |
| CFR Regulation Number | 864.3800 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 10 |
Data Problem | 9 |
Fluid Leak | 7 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Incorrect Or Inadequate Test Results | 5 |
Insufficient Information | 5 |
Filter | 3 |
Device Component Or Accessory | 3 |
Appropriate Term/Code Not Available | 3 |
Use Of Device Problem | 2 |
Failure To Deliver | 2 |
Inaccurate Dispensing | 2 |
None | 2 |
Fire | 2 |
Sparking | 2 |
Communication Or Transmission Problem | 2 |
Inaccurate Delivery | 2 |
Missing Value Reason | 1 |
Computer Software Problem | 1 |
Disconnection | 1 |
Misassembly During Maintenance / Repair | 1 |
False Negative Result | 1 |
False Positive Result | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Component Missing | 1 |
Smoking | 1 |
| Total Device Problems | 77 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-12-2018 |
| 2 | Dako North America Inc. | II | Apr-29-2015 |
| 3 | Dako North America Inc. | II | Mar-16-2015 |
| 4 | Dako North America Inc. | II | Sep-26-2014 |
| 5 | Hardy Diagnostics | II | Jul-08-2016 |
| 6 | Leica Microsystems, Inc. | II | Oct-26-2018 |
| 7 | Leica Microsystems, Inc. | II | Oct-03-2018 |