510(k) · Cleared
Recalled · Class II · 2017Vitek Gram Positive Identification Card (Gpi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux Vitek, Inc. · LQL Gram Positive Identification Panel
Cleared on Mar 12, 1996 after a 313-day review. The FDA summary names no predicate by number. It has been recalled 2 times.
- Decided
- Mar 12, 1996
- Review
- 313 days
- Class
- Class I
- Product code
- LQL
- Recalls
- 2
- Predicates
- 0
The FDA summary names no predicate by number.
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 LQL? 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2017 | Class II | Z-0074-2018 | Under Investigation by firm | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure… |
| Aug 25, 2017 | Class II | Z-3134-2017 | Under Investigation by firm | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LQL devicesLQL Gram Positive Identification Panel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQL
FDA has decided no LQL device since 2007.
Median 510(k) review, days · LQL
Too few LQL 510(k)s in any year since 2007 to give a median.
Recalls per year · LQL
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQL
23in 2025
MAUDE reports naming product code LQL, 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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 1 | 89 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 2 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus, Enterococcus gallinarum, and Enterococcus hirae is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.
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/K952095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952095: Vitek Gram Positive Identification Card (Gpi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026