# K991316: Touch Tear Ige Microassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Touch Scientific, Inc.
- Decided: Aug 9, 1999 after 112 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K083184: Tearlab Osmolarity System (2009), 1 descendant of its own
- K132066: Inflamma Dry (2013), 0 descendants of its own

## Indications for use
The TOUCH TEAR IGE MICROASSAY KIT is an in vitro diagnostic device which is used for the quantitative determination of Immunoglobulin E (IgE) concentration in human tears. This can be used as an aid in the diagnosis of ocular Type 1 allergic conjunctivitis or the allergic component of ocular inflammatory responses.

Source page: https://510kreport.com/device/K991316
Methodology: https://510kreport.com/methodology