# K971393: Mycoplasma Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immunoprobe, Inc.
- Decided: Jul 14, 1997 after 96 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. The FDA summary names its predicate without a number.
- (no number) IFA test: named in the summary without a submission number

## Indications for use
The Mycoplasma IgG ELISA™ kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

Source page: https://510kreport.com/device/K971393
Methodology: https://510kreport.com/methodology