510(k) · Cleared
ClearedhemoFISH Masterpanel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miacom Diagnostics GmbH · JSS Kit, Identification, Enterobacteriaceae
Cleared on Oct 1, 2015 as substantially equivalent to K123418 (Advandx, Inc., 2013) after a 266-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Oct 1, 2015
- Review
- 266 days
- Class
- Class I
- Product code
- JSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123418 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK123418 Gram-Negative Quickfish BCAdvandx, Inc. · 2013 · Recalled
- This deviceK150031 hemoFISH MasterpanelMiacom Diagnostics GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123418 | Gram-Negative Quickfish BC | Advandx, Inc. | 2013 | 1 |
| 0 (this device) | K150031 | hemoFISH Masterpanel | Miacom Diagnostics GmbH | 2015 | — |
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 JSS? 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 |
|---|---|---|---|
| * | K123418 | Gram-Negative Quickfish BCSummary page 5…device name(s) and predicate 510(k) number: Predicate Device Name 510(k) number Gram-Negative QuickFISH, AdvanDx, Inc. K123418 Comparison with Predicate: Item miacom Device Predicate QuickFISH Intended Use Blood culture i… | 2013 |
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?
- Its one ancestor has a recall.
How does its category compare?
All JSS devicesJSS Kit, Identification, Enterobacteriaceae: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JSS
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JSS
228in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSS
1in 2023
MAUDE reports naming product code JSS, 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 | 1 | — | 0 | 0 |
| 2009 | 4 | 228 | 0 | 0 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain and is intended for the identification of the following species / genera / families: Gram-positive Gram-negative Staphylococcus spp. Enterobacteriaceae Staphylococcus aureus Escherichia coli…
Read the full statement (170 words)
hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain and is intended for the identification of the following species / genera / families:
Gram-positive Gram-negative
Staphylococcus spp. Enterobacteriaceae
Staphylococcus aureus Escherichia coli
Streptococcus spp. Klebsiella pneumoniae
The hemoFISH Masterpanel is indicated as an aid in the diagnosis of specific agents of bacteremia and results should be used in conjunction with other clinical and laboratory findings. Positive hemoFISH Masterpanel results do not rule out co-infection with organisms not included in the hemoFISH Masterpanel. The hemoFISH Masterpanel is not intended to monitor treatment for bacteremia.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not identified by the hemoFISH Masterpanel, and for species determination of Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae that are not identified by the hemoFISH Masterpanel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150031: hemoFISH Masterpanel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150031
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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