510(k) Report

FDA product code · Microbiology

Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

NHYClass I21 CFR 866.3480510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.

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 NHY 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 · NHY

FDA has decided no NHY device since 2007.

Median 510(k) review, days · NHY

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

Recalls per year · NHY

No recall names NHY since 2007.

Adverse event reports per year · NHY

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code NHY, 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
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NHY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NHY? 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 866.3480.

LKT Respiratory Syncytial Virus, Antigen…GQF Antiserum, Neutralization, Respiratory…GQG Antigen, Cf (Including Cf Controls)…MCE Respiratory Syncytial Virus - Elisa