510(k) · Cleared

Cleared

Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni

K991726510(k) TraditionalCleared Aug 27, 199999-day reviewClass I21 CFR 866.3740

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

Binax, Inc. · GTZ Antisera, All Groups, Streptococcus Spp.

Cleared on Aug 27, 1999 as substantially equivalent to K854852 (Wellcome Diagnostics, 1986) after a 99-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Aug 27, 1999
Review: 99 days
Class: Class I
Product code: GTZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K854852 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK854852 Wellcogen Bacterial Antigen KitWellcome Diagnostics · 1986
This deviceK991726 Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test…Binax, Inc. · 1999
Descendant · cites it directly · 0 of its ownK191184 ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020

Most influential descendants

Showing 1 of 1 · See all

K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854852	Wellcogen Bacterial Antigen Kit	Wellcome Diagnostics	1986	—
0 (this device)	K991726	Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12…	Binax, Inc.	1999	—
+1	K191184	ImmuView S pneumoniae and L pneumophila Urinary Antigen Test	Ssi Diagnostica A/S	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K991726, 1986–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K854852	Wellcogen Bacterial Antigen Kit Summary page 1 …igen Test Strep pneumo ICT, Binax NOW® Strep pneumo test Streptococcus spp. serological reagents (per 21 CFR 8660.3740) Wellcogen Bacterial Antigen Kit, 510(k) number K854852 The Binax NOW® Streptococcus pneumoniae lrinary Antigen Test is an immunochromatographic membrane assay used to detect Streptoc…	Wellcome Diagnostics	1986	—

Also cleared against K854852: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191184	ImmuView S pneumoniae and L pneumophila Urinary Antigen Test	Ssi Diagnostica A/S	2020	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K191184 (Ssi Diagnostica A/S, 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K854852.

How does its category compare?

All GTZ devices

GTZ Antisera, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

What is it indicated for?

The Binax Now® Streptococcus pneumoniae Urinary Antigen Test is a rapid immunochromatographic assay for the detection of Streptococcus pneumoniae in human urine as an adjunct to culture for the presumptive diagnosis of pneumococcal pneumonia. It is intended for in vitro diagnostic use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991726 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991726: Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991726

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026