| Device Type ID | 6121 |
| Device Name | Lead, Atomic Absorption |
| Regulation Description | Lead Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DOF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6121 |
| Device | Lead, Atomic Absorption |
| Product Code | DOF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Lead Test System. |
| CFR Regulation Number | 862.3550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAGELLAN DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Sensing Problem | 30 |
Failure To Sense | 27 |
False Negative Result | 22 |
Complete Loss Of Power | 9 |
Battery Problem | 6 |
Device Handling Problem | 5 |
Noise, Audible | 4 |
Failure To Power Up | 3 |
Electrical Shorting | 3 |
Bent | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Smoking | 2 |
Leak / Splash | 2 |
Temperature Problem | 2 |
Calibration Problem | 2 |
Electrical Overstress | 1 |
Fluid Leak | 1 |
Overheating Of Device | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Imprecision | 1 |
Moisture Damage | 1 |
Improper Chemical Reaction | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Low Test Results | 1 |
Material Deformation | 1 |
Use Of Device Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Failure To Run On Battery | 1 |
Electrical Power Problem | 1 |
Product Quality Problem | 1 |
False Positive Result | 1 |
| Total Device Problems | 138 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Magellan Diagnostics, Inc. | II | Oct-26-2018 |
| 2 | Magellan Diagnostics, Inc. | II | Apr-03-2018 |
| 3 | Magellan Diagnostics, Inc. | II | Aug-15-2017 |
| 4 | Magellan Diagnostics, Inc. | I | Jun-05-2017 |
| 5 | Magellan Diagnostics, Inc. | I | May-18-2017 |