FDA product code MQM: Bilirubin (Total And Unbound) In The Neonate Test System
MQM is the FDA product code for bilirubin (total and unbound) in the neonate test system. It is a Class I device, regulated under 21 CFR 862.1113 and reviewed by the Clinical Chemistry panel. FDA has cleared 17 510(k) submissions under MQM, from 14 different applicants. The average 510(k) review took 212 days (median 193). FDA has posted 6 recalls for MQM devices.
Classification
| Field | Value |
|---|---|
| Device name | Bilirubin (Total And Unbound) In The Neonate Test System |
| Device class | Class I |
| Regulation | 21 CFR 862.1113 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MQM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 35 |
Compare with all 510(k) review times · Search every MQM clearance
Top MQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiometer Medical Aps | 2 | 2017-04-28 |
| Chromatics Color Sciences Intl., Inc. | 2 | 2001-09-13 |
| Respironics, Inc. | 2 | 2001-03-19 |
| Draeger Medical Systems, Inc. | 1 | 2014-11-13 |
| Siemens Healthcare Diagnostics | 1 | 2011-08-15 |
9 more applicants have MQM clearances. See the full list in Caduvo.
Most recent MQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170882 | Radiometer Medical Aps | ABL90 FLEX, ABL90 FLEX PLUS | 2017-04-28 | 35 |
| K133175 | Draeger Medical Systems, Inc. | DRAEGER JAUNDICE METER JM-105 | 2014-11-13 | 392 |
| K132691 | Radiometer Medical Aps | ABL90 FLEX | 2014-11-13 | 442 |
| K110277 | Siemens Healthcare Diagnostics | RAPIDPOINT 405 NEONATAL BILIRUBIN | 2011-08-15 | 196 |
| K073537 | Siemens Medical Solutions Diagnostics | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | 2008-06-27 | 193 |
Recalls for MQM devices
6 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-15.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code MQM?
MQM is the FDA product code for bilirubin (total and unbound) in the neonate test system. It is a Class I device, regulated under 21 CFR 862.1113 and reviewed by the Clinical Chemistry panel.
What device class is MQM?
Class I, regulation 21 CFR 862.1113. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQM?
Across 17 cleared submissions the average was 212 days from receipt to decision (median 193).
Which companies have the most MQM clearances?
Radiometer Medical Aps (2); Chromatics Color Sciences Intl., Inc. (2); Respironics, Inc. (2); Draeger Medical Systems, Inc. (1); Siemens Healthcare Diagnostics (1).
Have MQM devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2018-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MQM
- Run a recall and safety report across every MQM manufacturer
- Watch product code MQM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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