# K250249: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics, LLC
- Decided: Oct 10, 2025 after 256 days
- Product code: GMQ (Antigens, Nontreponemal, All)
- Device class: 2
- Regulation: 21 CFR 866.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851504 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150358: Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Gold Standard Diagnostics (2015) Summary page 5.

## Indications for use
The Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a non-treponemal flocculation test that can qualitatively determine the presence of reagin antibodies in human serum, automated on the AIX1000 Analyzer. It may be used to aid in the diagnosis of syphilis when used in conjunction with supplemental treponemal laboratory tests and other clinical information. This test may also be used to detect non-treponemal antibodies in samples serially diluted to establish titer information. This test is not intended for screening blood or tissue donors.

Source page: https://510kreport.com/device/K250249
Methodology: https://510kreport.com/methodology