FDA product code · Clinical Chemistry · Class 2
QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated
QBJ is FDA's product code for "Integrated Continuous Glucose Monitoring System, Factory Calibrated": a Class 2 device classified under 21 CFR 862.1355, reviewed by the Clinical Chemistry panel.
510(k) review time for QBJ
Across 17 510(k) clearances under QBJ decided from 2018-01-01 to 2026-10-06, the median was 87 days from FDA receipt to decision. Half took between 28 and 188 days, and 80% were decided within 198 days. These are past clearances, not a forecast for a new submission.
| Fastest | 12 |
|---|---|
| 25th percentile | 28 |
| Median | 87 |
| 75th percentile | 188 |
| 80th percentile | 198 |
| 90th percentile | 291 |
| Slowest | 422 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
QBJ in the public FDA record
| Device recalls | 23 |
|---|
Counts of records, not of devices or events. Adverse event reports for QBJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite QBJ
1 FDA recognized consensus standard cite QBJ, among them CLSI POCT05 2nd Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-307 CLSI POCT05 2nd Edition — Performance Metrics for Continuous Interstitial Glucose Monitoring
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.