FDA product code · Clinical Chemistry · Class 2
LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
LCX is FDA's product code for "Kit, Test, Pregnancy, Hcg, Over The Counter": a Class 2 device classified under 21 CFR 862.1155, reviewed by the Clinical Chemistry panel.
510(k) review time for LCX
Across 38 510(k) clearances under LCX decided from 2018-01-01 to 2026-10-06, the median was 155 days from FDA receipt to decision. Half took between 59 and 245 days, and 80% were decided within 259 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 59 |
| Median | 155 |
| 75th percentile | 245 |
| 80th percentile | 259 |
| 90th percentile | 290 |
| Slowest | 494 |
| Year | Median days | n |
|---|---|---|
| 2019 | 50 | 7 |
| 2022 | 264 | 6 |
| 2024 | 132 | 10 |
| 2025 | 102 | 5 |
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.
LCX in the public FDA record
| 510(k) clearances, all years | 226 |
|---|---|
| Device recalls | 25 |
| Establishment listings | 272 |
| GUDID device identifiers | 880 |
Counts of records, not of devices or events. Adverse event reports for LCX 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 LCX
No FDA recognized consensus standard cites LCX 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.