510(k) · Cleared
ClearedKeypath Mrsa/Mssa Blood Culture Test-BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microphage, Inc. · OUS Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
Cleared on Mar 30, 2012 as substantially equivalent to K102342 (Microphage, Inc., 2011) after a 35-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Mar 30, 2012
- Review
- 35 days
- Class
- Class I
- Product code
- OUS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020322 (2002). 10 ancestors in all, the oldest K851949 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 3 generations backK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- 2 generations backK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- 1 generation backK102342 Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011
- This deviceK120563 Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −3 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| −2 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| −1 | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | Microphage, Inc. | 2011 | — |
| 0 (this device) | K120563 | Keypath Mrsa/Mssa Blood Culture Test-BT | Microphage, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
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 OUS? 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
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 | Decided |
|---|---|---|---|
| * | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BTSummary page 1…bacteriophage Regulation 21 C.F.R. § 866.2050 Product Code OuIs Classification Panel Microbiology Predicate Devices KeyPath TM MRSAIMSSA Blood Culture Test - BT (ki102342) 18 Intended Use I Indications for Use The KeyPath"" MRSA/M… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 10 ancestors have a recall of any class.
How does its category compare?
All OUS devicesOUS Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OUS
1in 2012
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
MAUDE reports naming product code OUS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KeyPath TM MRSA/MSSA Blood Culture Test - BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures. The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of…
Read the full statement (184 words)
The KeyPath TM MRSA/MSSA Blood Culture Test - BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.
The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of oxacillin (a methicillin analog) resistance.
The assay is performed directly on positive blood culture specimens that are determined as Gram Positive Cocci in singles (GPC) or as Gram Positive Cocci in Clusters (GPCC) by Gram stain.
The KeyPath TM MRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTEC blood culture bottles (Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard Anaerobic/F).
The Test is indicated for use in conjunction with other laboratory and clinical data available to the physician as an aid in the detection of MRSA/MSSA from positive blood cultures.
Subculturing of positive blood cultures is necessary for additional susceptibility test determinations, differentiation of mixed growth and for epidemiological typing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120563: Keypath Mrsa/Mssa Blood Culture Test-BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120563
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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