510(k) · Cleared

Cleared

Mycoplasma Igm Elisa Test System

K971503510(k) TraditionalCleared Aug 20, 1997118-day reviewClass I21 CFR 866.3375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zeus Scientific, Inc. · LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Cleared on Aug 20, 1997 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Aug 20, 1997
Review: 118 days
Class: Class I
Product code: LJZ
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K971503Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LJZ devices

LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJZ

FDA has decided no LJZ device since 2007.

Median 510(k) review, days · LJZ

Too few LJZ 510(k)s in any year since 2007 to give a median.

Recalls per year · LJZ

3in 2008

2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LJZ

No MAUDE report names LJZ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	3	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

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…

Read the full statement (114 words)

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.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971503 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971503: Mycoplasma Igm Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971503

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026