FDA product code QLU: Anti-Factor Xa Activity Test System, Apixaban
QLU is the FDA product code for anti-factor xa activity test system, apixaban. It is a Class II device, regulated under 21 CFR 864.7295 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under QLU, 2 in the last five years, from 2 different applicants. The average 510(k) review took 252 days (median 252); 251 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QLU devices.
Definition
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Factor Xa Activity Test System, Apixaban |
| Device class | Class II |
| Regulation | 21 CFR 864.7295 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for QLU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 254 |
| 2024 | 1 | 251 |
Compare with all 510(k) review times · Search every QLU clearance
Top QLU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | 1 | 2024-10-10 |
| Instrumentation Laboratory CO | 1 | 2023-06-23 |
Most recent QLU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240315 | Siemens Healthcare Diagnostics Products GmbH | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | 2024-10-10 | 251 |
| K223187 | Instrumentation Laboratory CO | HemosIL Liquid Anti-Xa | 2023-06-23 | 254 |
Recalls for QLU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-08-25.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code QLU?
QLU is the FDA product code for anti-factor xa activity test system, apixaban. It is a Class II device, regulated under 21 CFR 864.7295 and reviewed by the Hematology panel.
What device class is QLU?
Class II, regulation 21 CFR 864.7295. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLU?
Across 2 cleared submissions the average was 252 days from receipt to decision (median 252).
Which companies have the most QLU clearances?
Siemens Healthcare Diagnostics Products GmbH (1); Instrumentation Laboratory CO (1).
Have QLU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-08-25.
Next steps
- Run an FDA pathway report with predicate devices for product code QLU
- Run a recall and safety report across every QLU manufacturer
- Watch product code QLU 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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