FDA product code · Microbiology

Antisera, All Groups, Streptococcus Spp.

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

GTZClass I21 CFR 866.3740510(k) exempt105 decisions since 19762 recalls

FDA lists GTZ 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. 105 FDA decisions since 1976. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K901274, named by 1 later device.

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 GTZ 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 · GTZ

FDA has decided no GTZ device since 2007.

Median 510(k) review, days · GTZ

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

Recalls per year · GTZ

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GTZ

10in 2025

2007high 10 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	1	0
2010	—	0	0
2011	—	0	2
2012	—	0	0
2013	—	0	1
2014	—	0	0
2015	—	0	0
2016	—	0	1
2017	—	0	2
2018	—	0	8
2019	—	0	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	4
2025	—	0	10
2026	—	0	—

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

Planning a device in GTZ? 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 866.3740.

OAH Fish (Fluorescent In Situ Hybridization) Kit…MCT Dna-Probe, Strep Pneumoniae OYZ Group A Streptococcus Nucleic Acid…GWC Antisera, All Types, Streptococcus Pneumoniae MDK Dna-Probe, Reagents, Streptococcal GWB Antisera, Fluorescent, All Types…GTX Antisera, Fluorescent, All Groups…GTY Antigens, All Groups, Streptococcus Spp.NJR Nucleic Acid Amplification Assay System, Group…

Antisera, All Groups, Streptococcus Spp.

Which predicates do GTZ devices cite most?

Which GTZ devices have the deepest lineage?

What has FDA decided in GTZ lately?

What has been recalled in GTZ lately?

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