# K132066: Inflamma Dry

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Pathogen Screening, Inc.
- Decided: Nov 21, 2013 after 141 days
- Product code: PFQ (Mmp-9 Test System)
- Device class: 1
- Regulation: 21 CFR 862.1540
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940043 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083184: Tearlab Osmolarity System, Ocusense, Inc. (2009) Summary page 1.

## Recalls of this device
- Mar 5, 2024 · Class II · Z-1637-2024: There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivi
- Mar 5, 2024 · Class II · Z-1636-2024: There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivi
- Jun 22, 2017 · Class II · Z-2803-2017: In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.

## Indications for use
InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites. InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.

Source page: https://510kreport.com/device/K132066
Methodology: https://510kreport.com/methodology