# K971503: Mycoplasma Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Aug 20, 1997 after 118 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
M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is préminent, 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 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/K971503
Methodology: https://510kreport.com/methodology