FDA product code JJS: Controls For Blood-Gases, (Assayed And Unassayed)
JJS is the FDA product code for controls for blood-gases, (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 67 510(k) submissions under JJS, from 30 different applicants. The average 510(k) review took 47 days (median 35). FDA has posted 1 recall for JJS devices.
Classification
| Field | Value |
|---|---|
| Device name | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJS clearance
Top JJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 9 | 2002-08-15 |
| Radiometer America, Inc. | 9 | 1998-01-28 |
| Phoenix Diagnostics, Inc. | 5 | 1995-01-17 |
| Bionostics, Inc. | 5 | 1992-06-30 |
| Radiometer Medical Aps | 3 | 2015-05-13 |
25 more applicants have JJS clearances. See the full list in Caduvo.
Most recent JJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152553 | Eurotrol B.V. | CueSee Hypoxic | 2016-04-22 | 227 |
| K150226 | Radiometer Medical Aps | Hematocrit and Metabolite QUALICHECK | 2015-05-13 | 100 |
| K130415 | Radiometer Medical Aps | HIGH METABOLITE QUALICHECK | 2013-03-26 | 35 |
| K130236 | Radiometer Medical Aps | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | 2013-03-15 | 44 |
| K033063 | Diamond Diagnostics, Inc. | MISSION CONTROLS | 2003-12-12 | 74 |
Recalls for JJS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JJS?
JJS is the FDA product code for controls for blood-gases, (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is JJS?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJS?
Across 67 cleared submissions the average was 47 days from receipt to decision (median 35).
Which companies have the most JJS clearances?
Bio-Rad (9); Radiometer America, Inc. (9); Phoenix Diagnostics, Inc. (5); Bionostics, Inc. (5); Radiometer Medical Aps (3).
Have JJS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-09-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JJS
- Run a recall and safety report across every JJS manufacturer
- Watch product code JJS 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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