FDA product code · Hematology · Class 2
JPA: System, Multipurpose For In Vitro Coagulation Studies
JPA is FDA's product code for "System, Multipurpose For In Vitro Coagulation Studies": a Class 2 device classified under 21 CFR 864.5425, reviewed by the Hematology panel.
510(k) review time for JPA
Across 14 510(k) clearances under JPA decided from 2018-01-01 to 2026-10-06, the median was 197 days from FDA receipt to decision. Half took between 39 and 446 days, and 80% were decided within 511 days. These are past clearances, not a forecast for a new submission.
| Fastest | 22 |
|---|---|
| 25th percentile | 39 |
| Median | 197 |
| 75th percentile | 446 |
| 80th percentile | 511 |
| 90th percentile | 641 |
| Slowest | 767 |
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.
JPA in the public FDA record
| 510(k) clearances, all years | 181 |
|---|---|
| Device recalls | 43 |
| Establishment listings | 163 |
Counts of records, not of devices or events. Adverse event reports for JPA 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 JPA
3 FDA recognized consensus standards cite JPA, among them CLSI H21-A5; CLSI POCT14 2nd Edition; CLSI GP42 7th Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-159 CLSI H21-A5 — Collection Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
- 7-299 CLSI POCT14 2nd Edition — Point-of-Care Coagulation Testing and Anticoagulation Monitoring
- 7-301 CLSI GP42 7th Edition — Collection of Capillary Blood Specimens
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.