FDA product code PII: Candida Species Nucleic Acid Detection System
PII is the FDA product code for candida species nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3960 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under PII, 1 in the last five years. The average 510(k) review took 146 days (median 146); 266 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PII devices.
Definition
The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
Classification
| Field | Value |
|---|---|
| Device name | Candida Species Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.3960 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PII
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 27 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every PII clearance
Top PII applicants
| Applicant | Clearances | Latest |
|---|---|---|
| T2biosystems, Inc. | 2 | 2024-09-13 |
Most recent PII clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234063 | T2biosystems, Inc. | T2Candida 1.1 Panel | 2024-09-13 | 266 |
| K173536 | T2biosystems, Inc. | T2Candida 1.1 Panel | 2017-12-12 | 27 |
Recalls for PII devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-07.
Frequently asked questions
What is FDA product code PII?
PII is the FDA product code for candida species nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3960 and reviewed by the Microbiology panel.
What device class is PII?
Class II, regulation 21 CFR 866.3960. Typical premarket route: 510(k).
How long does a 510(k) take for product code PII?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most PII clearances?
T2biosystems, Inc. (2).
Have PII devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code PII
- Run a recall and safety report across every PII manufacturer
- Watch product code PII 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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