510(k) Report

FDA product code · Microbiology

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

OUSClass I21 CFR 866.2050510(k) required2 decisions since 20110 recalls

2 FDA decisions since 2011. No recall names this code. The most-cited predicate is K102342, named by 1 later device.

The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.

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 OUS 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 · OUS

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUS

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

Recalls per year · OUS

No recall names OUS since 2007.

Adverse event reports per year · OUS

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code OUS, 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
20111—01
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OUS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OUS? 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

Which predicates do OUS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 20111cites it

Which OUS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 20124generations
  • K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 20113generations

What has FDA decided in OUS lately?

  • K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 2012
  • K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011

All 2 OUS decisions →

Related product codes

Other codes under 21 CFR 866.2050.

GTL Phages, Staphylococcal Typing, All Types