# K993727: Bindazyme Anti-Dsdna Eia Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Dec 21, 1999 after 57 days
- Product code: LRM (Anti-Dna Antibody (Enzyme-Labeled), 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.
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
- K152013: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (2016), 1 descendant of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own

## Indications for use
This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K993727
Methodology: https://510kreport.com/methodology