# K984153: The Aptus (Automated) Application of the Mycoplasma Igm Elisa Test System.

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 11, 1999 after 53 days
- Product code: LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient’s serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the manual or automated, qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984153
Methodology: https://510kreport.com/methodology