# K984544: The Aptus (Automated) Application of the HM-Cap Eia Kit. an Enzyme Linked Immunosorbent Assay for the Detection of the S

- Pathway: 510(k) (Traditional)
- Applicant: Enteric Products, Inc.
- Decided: Feb 18, 1999 after 58 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K052716: Rapirun H. Pylori Antibody Detection Kit (2006), 0 descendants of its own

## Indications for use
The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test for the detection of IgG antibodies in serum or plasma in adult symptomatic patients which is intended for professional in-vitro use as an adjunct or aid in the diagnosis of Helicobacter pylori.

Source page: https://510kreport.com/device/K984544
Methodology: https://510kreport.com/methodology