510(k) · Cleared

Cleared

Binaxnow PBP2A Test, Model 890-000

K090301510(k) TraditionalCleared Apr 14, 2010432-day reviewClass II21 CFR 866.1640

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

Binax, Inc. · MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Cleared on Apr 14, 2010 as substantially equivalent to K850291 (Remel Co., 1985) and 1 other predicate after a 432-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Apr 14, 2010
Review: 432 days
Class: Class II
Product code: MYI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K850291 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
This deviceK090301 Binaxnow PBP2A Test, Model 890-000Binax, Inc. · 2010
Descendant · cites it directly · 0 of its ownK140619 Meca XpressfishAdvandx, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K140619Meca XpressfishAdvandx, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850291	Mueller Hinton Agar W/4% Nacl W/Antibiotics	Remel Co.	1985	2
0 (this device)	K090301	Binaxnow PBP2A Test, Model 890-000	Binax, Inc.	2010	—
+1	K140619	Meca Xpressfish	Advandx, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K090301, 1985–2014Source: 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 MYI? 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

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What was it cleared against? (2)

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
*	K850291	Mueller Hinton Agar W/4% Nacl W/Antibiotics Summary page 1 …Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (MYI) (per 21 CFR 866.1640) PREDICATE DEVICES Mueller Hinton Agar w/4% NaCI xv/Antibiotics (Remel) K850291 PBP2' Latex Agglutination Test (Oxoid) KOI 1710 DEVICE DESCRIPTION The BinaxNOW'* PBP2a Test is a rapid immunochromatographic me…	Remel Co.	1985	2
*	K011710	Oxoid PBP2 1 Latex Agglutination Test	Oxoid, Ltd.	2002	—

Also cleared against K850291: 2 other devices →

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
K140619	Meca Xpressfish	Advandx, Inc.	2014	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K140619 (Advandx, Inc., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K850291.

How does its category compare?

All MYI devices

MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MYI

2in 2014

2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MYI

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

Recalls per year · MYI

No recall names MYI since 2007.

Adverse event reports per year · MYI

2in 2023

2007high 2 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	2	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	2	—	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	—	2
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillin-resistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus.

The BinaxNOWO PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

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/K090301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090301: Binaxnow PBP2A Test, Model 890-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090301

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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