# K792610: Kallestad Florescent Ana/Ama/Asma Test

- Pathway: 510(k) (Traditional)
- Applicant: Kallestad Laboratories, Inc.
- Decided: Feb 22, 1980 after 66 days
- Product code: DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 7 cite it directly.
0 of 8 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
- K024230: Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131 (2003), 0 descendants of its own
- K024224: Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129 (2003), 0 descendants of its own
- K024227: Liquichek Anti-Mitochondrial Control, Positive, Catalog #127 (2003), 0 descendants of its own
- K024217: Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108 (2003), 0 descendants of its own
- K024221: Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118 (2003), 0 descendants of its own

## Recalls of this device
- Jul 29, 2008 · Not classified · Z-2430-2008: 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/K792610
Methodology: https://510kreport.com/methodology