510(k) · Cleared
ClearedKeypath (TM) 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 May 5, 2011 as substantially equivalent to K071026 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2007) and 2 other predicates after a 260-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- May 5, 2011
- Review
- 260 days
- Class
- Class I
- Product code
- OUS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K020322 (2002). 9 ancestors in all, the oldest K851949 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 2 generations backK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- 1 generation backK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- This deviceK102342 Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK120563 Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −2 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| −1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| 0 (this device) | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | Microphage, Inc. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (6)
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 |
|---|---|---|---|
| * | K071026 | BD Geneohm Staphsr AssaySummary page 2…I www.microphage.com MicroPhage KeyPath T M MSAIMSSA Blood Culture Test - BT: 5 10O(k) Summary Predicate Devices: K071026 BD GeneOhMTM StaphSR Assay K85 1949 Wellcome (Remel) Staphaurex® ZL3O… | 2007 |
| * | K851949 | Staphaurex ZL30Summary page 2…croPhage KeyPath T M MSAIMSSA Blood Culture Test - BT: 5 10O(k) Summary Predicate Devices: K071026 BD GeneOhMTM StaphSR Assay K85 1949 Wellcome (Remel) Staphaurex® ZL3O KOl 1710 Oxoid PBP2' Latex Agglutination… | 1985 |
| * | K011710 | Oxoid PBP2 1 Latex Agglutination Test | 2002 |
| * | — | Coagulase Test and Catalase Test (multiple manufacturers) Named without a submission number | |
| * | — | BD BBL 30 µg cefoxitin Sensi-Disc Named without a submission number | |
| * | — | BD BBL 1 µg oxacillin Sensi-Disc Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120563 | Keypath Mrsa/Mssa Blood Culture Test-BT | 2012 | 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K120563 (Microphage, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K071026.
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. 2011, 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 T M 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 (180 words)
The KeyPath T M 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 TMMRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTECTM blood culture bottles (Plus Aerobic/F and Plus 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/K102342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102342
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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