FDA product code · Microbiology

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

Name: FDA decisions, review times, recalls and adverse event reports for product code NXX
Creator: 510(k) Report

NXXClass I21 CFR 866.3700510(k) exempt4 decisions since 20060 recalls

FDA lists NXX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 2006. No recall names this code. The most-cited predicate is K060099, named by 1 later device.

The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).

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 NXX 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 · NXX

1in 2012

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NXX

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

Recalls per year · NXX

No recall names NXX since 2007.

Adverse event reports per year · NXX

No MAUDE report names NXX since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	2	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

FIG. 1 — NXX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NXX? 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

Related product codes

Other codes under 21 CFR 866.3700.

LHJ Staphylococcus Aureus Protein A Insoluble GTN Antisera, Fluorescent, All Types…LHT Staphylococcus Aureus Somatic Antigens MCS Dna-Probe, Staphylococcus Aureus

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

Which predicates do NXX devices cite most?

What has FDA decided in NXX lately?

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