FDA product code MSQ: Test, Urea (Breath Or Blood)
MSQ is the FDA product code for test, urea (breath or blood). It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. FDA has cleared 17 510(k) submissions under MSQ, 3 in the last five years, from 9 different applicants. The average 510(k) review took 109 days (median 86). FDA has posted 2 recalls for MSQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Urea (Breath Or Blood) |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MSQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 86 |
| 2020 | 1 | 42 |
| 2022 | 3 | 107 |
Compare with all 510(k) review times · Search every MSQ clearance
Top MSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exalenz Bioscience , Ltd. | 5 | 2020-02-06 |
| Meridian Bioscience Israel , Ltd. | 3 | 2022-12-19 |
| Otsuka Pharmaceutical Co., Ltd. | 2 | 2010-03-09 |
| Meretek Diagnostics, Inc. | 2 | 2002-01-17 |
| Hema Metrics, LLC | 1 | 2010-09-29 |
4 more applicants have MSQ clearances. See the full list in Caduvo.
Most recent MSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221896 | Meridian Bioscience Israel , Ltd. | BreathID Hp System | 2022-12-19 | 172 |
| K223185 | Meridian Bioscience Israel , Ltd. | BreathID® Smart System | 2022-11-10 | 29 |
| K220494 | Meridian Bioscience Israel , Ltd. | BreathID Hp Lab System, BreathID Smart System | 2022-06-23 | 121 |
| K193610 | Exalenz Bioscience , Ltd. | BreathID Smart System | 2020-02-06 | 42 |
| K173772 | Exalenz Bioscience , Ltd. | BreathID Hp System | 2018-03-08 | 86 |
Recalls for MSQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-06-07.
Frequently asked questions
What is FDA product code MSQ?
MSQ is the FDA product code for test, urea (breath or blood). It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is MSQ?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSQ?
Across 17 cleared submissions the average was 109 days from receipt to decision (median 86).
Which companies have the most MSQ clearances?
Exalenz Bioscience , Ltd. (5); Meridian Bioscience Israel , Ltd. (3); Otsuka Pharmaceutical Co., Ltd. (2); Meretek Diagnostics, Inc. (2); Hema Metrics, LLC (1).
Have MSQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-06-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MSQ
- Run a recall and safety report across every MSQ manufacturer
- Watch product code MSQ 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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