| Device Type ID | 2299 |
| Device Name | Test, Time, Prothrombin |
| Regulation Description | Prothrombin Time Test. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GJS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2299 |
| Device | Test, Time, Prothrombin |
| Product Code | GJS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Prothrombin Time Test. |
| CFR Regulation Number | 864.7750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ILINE MICROSYSTEMS S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 2347 |
Test Strip | 1615 |
Incorrect Or Inadequate Test Results | 1301 |
Low Test Results | 501 |
Non Reproducible Results | 266 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 256 |
Image Display Error / Artifact | 65 |
Adverse Event Without Identified Device Or Use Problem | 53 |
Display | 52 |
Improper Or Incorrect Procedure Or Method | 43 |
Display Or Visual Feedback Problem | 40 |
No Display / Image | 26 |
Device Issue | 12 |
Unauthorized Access To Computer System | 10 |
Device Displays Incorrect Message | 8 |
Insufficient Information | 8 |
Thermal Decomposition Of Device | 6 |
Erratic Or Intermittent Display | 6 |
Use Of Device Problem | 6 |
PC (Printed Circuit) Board | 6 |
False Positive Result | 5 |
Melted | 5 |
No Apparent Adverse Event | 4 |
Appropriate Term/Code Not Available | 4 |
Unexpected Therapeutic Results | 4 |
Circuit Board | 3 |
Electrical /Electronic Property Problem | 3 |
Unable To Obtain Readings | 3 |
Housing | 3 |
Mechanical Problem | 3 |
Nonstandard Device | 2 |
Device Markings / Labelling Problem | 2 |
False Negative Result | 2 |
Patient Data Problem | 2 |
Label | 2 |
Power Supply | 2 |
Display Difficult To Read | 2 |
Failure To Read Input Signal | 2 |
Expiration Date Error | 2 |
Date/Time-Related Software Problem | 2 |
Device Operates Differently Than Expected | 2 |
Human-Device Interface Problem | 2 |
Missing Test Results | 1 |
False Reading From Device Non-Compliance | 1 |
Battery | 1 |
Product Quality Problem | 1 |
LED (Light Emitting Diode) | 1 |
Valve | 1 |
Pin | 1 |
Corroded | 1 |
Loss Of Data | 1 |
Smoking | 1 |
Screen | 1 |
Occlusion Within Device | 1 |
Inadequate Service | 1 |
Chassis | 1 |
High Readings | 1 |
Device Handling Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Human Factors Issue | 1 |
Cover | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Subassembly | 1 |
Shelf Life Exceeded | 1 |
Device Expiration Issue | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
| Total Device Problems | 6712 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Point Of Care Inc. | II | Aug-10-2015 |
| 2 | Alere San Diego, Inc. | I | Aug-19-2016 |
| 3 | Alere San Diego, Inc. | I | Jan-03-2015 |
| 4 | Alere San Diego, Inc. | I | May-08-2014 |
| 5 | Diagnostica Stago, Inc. | II | Sep-07-2018 |
| 6 | Diagnostica Stago, Inc. | II | Mar-15-2018 |
| 7 | Fisher Diagnostics, A Company Of Fisher Scientific LLC | II | Jun-26-2015 |
| 8 | Instrumentation Laboratory Co. | II | Oct-05-2018 |
| 9 | Instrumentation Laboratory Co. | II | Mar-03-2018 |
| 10 | Instrumentation Laboratory Co. | II | Dec-19-2014 |
| 11 | Roche Diagnostics Corporation | I | Nov-02-2018 |
| 12 | TERRIFIC CARE LLC | I | Feb-01-2019 |