# K813592: Quantafluor Fluorescent Test Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Kallestad Laboratories, Inc.
- Decided: Jan 18, 1982 after 21 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984397: Liquichek Ana Control, Centromere Pattern, Model 203 (1998), 2 descendants of its own
- K024230: Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131 (2003), 0 descendants of its own
- K024222: Liquichek Ana Control Centromere Pattern, Positive, Catalog #112 (2003), 0 descendants of its own
- K984396: Liquichek Anti-Dsdna Control, Model 213 (1998), 0 descendants of its own
- K984399: Liquichek Ana Control, Nucleolar Pattern, Model 204 (1998), 0 descendants of its own

## Recalls of this device
- Jun 30, 2010 · Not classified · Z-3051-2011: KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
- Jul 29, 2008 · Not classified · Z-2429-2008: The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

Source page: https://510kreport.com/device/K813592
Methodology: https://510kreport.com/methodology