510(k) · Cleared
ClearediC-GPC Assay TM for use on the iC-SystemTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icubate, Inc. · PAM Gram-Positive Bacteria And Their Resistance Markers
Cleared on Aug 8, 2017 as substantially equivalent to K122514 (Nanosphere, Inc., 2012) after a 249-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Aug 8, 2017
- Review
- 249 days
- Class
- Class II
- Product code
- PAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN120014 (2012). No later device cites it as a predicate yet.
- Root · 2 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 1 generation backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- This deviceK163390 iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −1 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| 0 (this device) | K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Icubate, Inc. | 2017 | — |
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 PAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PAM device
- #1 K254194 QIAstat-Dx BCID GPF Plus AMR Panelscore 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestSummary page 6…-System™ VERIGENE® Gram Positive Blood Culture Nucleic (New Device) Acid Test (BC-GP) (K122514) (Primary Predicate Device)… | 2012 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K122514.
How does its category compare?
All PAM devicesPAM Gram-Positive Bacteria And Their Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PAM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAM
Too few PAM 510(k)s in any year since 2007 to give a median.
Recalls per year · PAM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAM
75in 2025
MAUDE reports naming product code PAM, 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 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 3 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 106 |
| 2024 | 0 | — | 0 | 422 |
| 2025 | 1 | — | 0 | 75 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The iCubate iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. Cultures demonstrating mixed Gram stain results should not be tested with the assay. The iC-GPC…
Read the full statement (263 words)
The iCubate iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. Cultures demonstrating mixed Gram stain results should not be tested with the assay. The iC-GPC Assay is validated for use with select BACTEC, BacT/ALERT and VersaTREK blood culture bottles. The iC-GPC Assay is indicated for use in conjunction with other clinical and laboratory findings, such as blood culture isolate identification and antimicrobial susceptibility testing, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.
The iC-GPC Assay detects organism DNA and identifies the following bacterial species and resistance markers:
Bacterial Species
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Enterococcus faecalis
Enterococcus faecium
Resistance Markers
mecA- associated with methicillin resistance
vanA- associated with vancomycin resistance
vanB- associated with vancomycin resistance
The iC-GPC Assay detects the mecA resistance marker, inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, the iC-GPC Assay does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by the iC-GPC Assay, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for 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/K163390 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163390: iC-GPC Assay TM for use on the iC-SystemTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163390
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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