FDA product code NRP: Sirolimus Test System
NRP is the FDA product code for sirolimus test system. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under NRP, from 4 different applicants. The average 510(k) review took 161 days (median 156). 1 De Novo request was granted under it. FDA has posted 6 recalls for NRP devices.
Definition
Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Classification
| Field | Value |
|---|---|
| Device name | Sirolimus Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3840 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NRP clearance
Top NRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 2009-03-30 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2008-10-30 |
| Fujirebio Diagnostics,Inc. | 1 | 2007-09-28 |
| Axis-Shield , Ltd. | 1 | 2005-04-07 |
Most recent NRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083487 | Siemens Healthcare Diagnostics | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | 2009-03-30 | 125 |
| K081857 | Siemens Healthcare Diagnostics, Inc. | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | 2008-10-30 | 121 |
| K070822 | Fujirebio Diagnostics,Inc. | ARCHITECT SIROLIMUS ASSAY | 2007-09-28 | 186 |
| K042411 | Axis-Shield , Ltd. | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | 2005-04-07 | 212 |
Recalls for NRP devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code NRP?
NRP is the FDA product code for sirolimus test system. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel.
What device class is NRP?
Class II, regulation 21 CFR 862.3840. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRP?
Across 4 cleared submissions the average was 161 days from receipt to decision (median 156).
Which companies have the most NRP clearances?
Siemens Healthcare Diagnostics (1); Siemens Healthcare Diagnostics, Inc. (1); Fujirebio Diagnostics,Inc. (1); Axis-Shield , Ltd. (1).
Have NRP devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2018-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NRP
- Run a recall and safety report across every NRP manufacturer
- Watch product code NRP 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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