510(k) Report

FDA product code · Microbiology

Candida Species Nucleic Acid Detection System

PIIClass II21 CFR 866.3960510(k) required3 decisions since 20140 recalls

3 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 266 days (half between 266 and 266). No recall names this code. The most-cited predicate is DEN140019, named by 2 later devices.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of PII at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PII

1in 2024

2014: 12017: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PII

Too few PII 510(k)s in any year since 2007 to give a median.

Recalls per year · PII

No recall names PII since 2007.

Adverse event reports per year · PII

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code PII, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20241—00
20250—00
20260—0—
FIG. 1 — PII by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PII? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PII devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN140019T2CANDIDA and T2DX InstrumentT2biosystems, Inc. · 20142cite it
  • K173536T2Candida 1.1 PanelT2biosystems, Inc. · 20171cites it

Which PII devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K234063T2Candida 1.1 PanelT2biosystems, Inc. · 20242generations
  • K173536T2Candida 1.1 PanelT2biosystems, Inc. · 20171generation

What has FDA decided in PII lately?

  • K234063T2Candida 1.1 PanelT2biosystems, Inc. · 2024
  • K173536T2Candida 1.1 PanelT2biosystems, Inc. · 2017
  • DEN140019T2CANDIDA and T2DX InstrumentT2biosystems, Inc. · 2014

All 3 PII decisions →

Related product codes

Other codes under 21 CFR 866.3960.

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