FDA product code QJS: Interoperable Automated Glycemic Controller, Insulin Suspend
QJS is the FDA product code for interoperable automated glycemic controller, insulin suspend. It is a Class II device, regulated under 21 CFR 862.1356 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under QJS. The average 510(k) review took 73 days (median 73).
Definition
An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Classification
| Field | Value |
|---|---|
| Device name | Interoperable Automated Glycemic Controller, Insulin Suspend |
| Device class | Class II |
| Regulation | 21 CFR 862.1356 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QJS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 73 |
Compare with all 510(k) review times · Search every QJS clearance
Top QJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tandem Diabetes Care, Inc. | 1 | 2020-02-28 |
Most recent QJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193483 | Tandem Diabetes Care, Inc. | Basal-IQ Technology | 2020-02-28 | 73 |
Recalls for QJS devices
openFDA lists no recalls for product code QJS.
Frequently asked questions
What is FDA product code QJS?
QJS is the FDA product code for interoperable automated glycemic controller, insulin suspend. It is a Class II device, regulated under 21 CFR 862.1356 and reviewed by the Clinical Chemistry panel.
What device class is QJS?
Class II, regulation 21 CFR 862.1356. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJS?
Across 1 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most QJS clearances?
Tandem Diabetes Care, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJS
- Run a recall and safety report across every QJS manufacturer
- Watch product code QJS 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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