510(k) · Cleared
ClearedAvanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar Lipids Bulk BDRL Antigen, Avanti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanti Polar Lipids, Inc. · GMQ Antigens, Nontreponemal, All
Cleared on Sep 20, 1999 after an 89-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 20, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- GMQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 GMQ? 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 GMQ device
- #1 K250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid…score 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | VDRL Antigen For Syphilis Serology. Becton Dickinson Microbiology Systems, Becton… Named without a submission number | |
| * | — | Cenogenics ADRL/STS Test. Cenogenics Corporation Named without a submission number | |
| * | — | VDRL Antigen. Lee Laboratories, Inc. Named without a submission number | |
| * | — | VDRL Antigen. Centers for Disease Control and Prevention Named without a submission 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GMQ devicesGMQ Antigens, Nontreponemal, All: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GMQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GMQ
Too few GMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GMQ
No recall names GMQ since 2007.
Adverse event reports per year · GMQ
2in 2024
MAUDE reports naming product code GMQ, 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 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test detects the presence of IgM and IgG anticardiolipin antibodies in serum. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis.
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/K992124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992124: Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar Lipids Bulk BDRL Antigen, Avanti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992124
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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