# K012163: Polytiter System

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Aug 20, 2001 after 40 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PolyTiter mmunofluorescent Titration System including the calibrator solutions is designed to assist in the semi-quantitative determination (titer/pattern) of the anti nuclear antibody (ANA) reaction in the in vitro microscopic immuno-fluorescent assay. The PolyTiter System may be used as an aid in the diagnosis and mm%nt of autoi%c diseases.

Source page: https://510kreport.com/device/K012163
Methodology: https://510kreport.com/methodology