| Device Type ID | 595 |
| Device Name | Automated Urinalysis System |
| Regulation Description | Automated Urinalysis System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KQO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 595 |
| Device | Automated Urinalysis System |
| Product Code | KQO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Automated Urinalysis System. |
| CFR Regulation Number | 862.2900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACON LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YD DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 347 |
False Negative Result | 184 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 128 |
Leak / Splash | 47 |
Probe | 33 |
Pad | 33 |
Fluid Leak | 27 |
Device Inoperable | 26 |
Low Test Results | 22 |
Output Problem | 19 |
Device Operational Issue | 16 |
Charred | 14 |
Filter | 11 |
High Test Results | 11 |
Thermal Decomposition Of Device | 10 |
Incorrect Or Inadequate Test Results | 9 |
Device Emits Odor | 9 |
Tube | 8 |
False Positive Result | 8 |
Issue With Displayed Error Message | 7 |
Electrical /Electronic Property Problem | 6 |
Optical Distortion | 6 |
Pipette | 6 |
Patient Data Problem | 5 |
Test Strip | 5 |
Improper Device Output | 4 |
Circuit Board | 4 |
Syringe | 4 |
Melted | 4 |
Optical Cable | 4 |
Motor | 4 |
Reader | 4 |
Computer Software Problem | 4 |
Connector | 3 |
Pump | 3 |
Syringe Drive | 3 |
Protective Measures Problem | 3 |
Pumping Problem | 3 |
Smoking | 3 |
Device Displays Incorrect Message | 3 |
Label | 3 |
Lamp | 3 |
Device Component Or Accessory | 3 |
Failure To Prime | 2 |
Communication Or Transmission Problem | 2 |
Use Of Device Problem | 2 |
Power Supply | 2 |
No Flow | 2 |
Cell | 2 |
Device-Device Incompatibility | 2 |
Camera | 2 |
Crack | 2 |
Improper Flow Or Infusion | 1 |
Housing | 1 |
Loose Or Intermittent Connection | 1 |
Electrical Shorting | 1 |
Incorrect Device Or Component Shipped | 1 |
IC (Integrated Circuit) Chip | 1 |
Valve, Control | 1 |
Accessory Incompatible | 1 |
Analyzer | 1 |
Extractor | 1 |
Flowmeter | 1 |
Plunger | 1 |
Altitude Variations | 1 |
Complete Blockage | 1 |
Loss Of Power | 1 |
Component Or Accessory Incompatibility | 1 |
Installation-Related Problem | 1 |
Mechanical Jam | 1 |
Screw | 1 |
Printer | 1 |
Obstruction Of Flow | 1 |
Failure To Calibrate | 1 |
Inadequate Lighting | 1 |
Motherboard | 1 |
Detector | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Increase In Pressure | 1 |
Non Reproducible Results | 1 |
Cable | 1 |
CPU (Central Processing Unit Of Computer System) | 1 |
Sparking | 1 |
Application Program Version Or Upgrade Problem | 1 |
Valve | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
| Total Device Problems | 1111 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-04-2018 |
| 2 | Beckman Coulter Inc. | II | Apr-27-2018 |
| 3 | Beckman Coulter Inc. | II | Apr-12-2018 |
| 4 | Beckman Coulter Inc. | II | Apr-11-2018 |
| 5 | Beckman Coulter Inc. | II | Mar-01-2017 |
| 6 | Beckman Coulter Inc. | II | Mar-08-2016 |
| 7 | Iris Diagnostics | II | Aug-21-2015 |
| 8 | Siemens Healthcare Diagnostics Inc | III | May-04-2014 |