FDA product code · Clinical Chemistry · Class 2
PDJ: Hemoglobin A1c Test System
PDJ is FDA's product code for "Hemoglobin A1c Test System": a Class 2 device classified under 21 CFR 862.1373, reviewed by the Clinical Chemistry panel.
510(k) review time for PDJ
Across 13 510(k) clearances under PDJ decided from 2018-01-01 to 2026-10-06, the median was 230 days from FDA receipt to decision. Half took between 130 and 283 days, and 80% were decided within 405 days. These are past clearances, not a forecast for a new submission.
| Fastest | 31 |
|---|---|
| 25th percentile | 130 |
| Median | 230 |
| 75th percentile | 283 |
| 80th percentile | 405 |
| 90th percentile | 509 |
| Slowest | 892 |
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.
PDJ in the public FDA record
| Device recalls | 9 |
|---|
Counts of records, not of devices or events. Adverse event reports for PDJ 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 PDJ
No FDA recognized consensus standard cites PDJ by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.