510(k) · Cleared

Cleared

Rhigene Ana Elisa Test System

K994071510(k) TraditionalCleared Jan 18, 200047-day reviewClass II21 CFR 866.5100

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

Rhigene, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Cleared on Jan 18, 2000 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jan 18, 2000
Review: 47 days
Class: Class II
Product code: LJM
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K994071Source: 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 LJM devices

LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJM

1in 2018

2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJM

265in 2014

2007high 265 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJM

2in 2008

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LJM

No MAUDE report names LJM since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	2	0
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	3	265	0	0
2015	0	—	0	0
2016	1	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The RhiGene ANA ELISA TEST SYSTEM is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene ANA ELISA TEST SYSTEM is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases. The RhiGene ANA ELISA TEST SYSTEM uses a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, Scl-70, CENP-B and native purified proteins…

Read the full statement (108 words)

The RhiGene ANA ELISA TEST SYSTEM uses a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, Scl-70, CENP-B and native purified proteins of SS-A, Sm, dsDNA and ssDNA for the solid phase antigen. Therefore, the test shows increased specificity for detection of disease-specific connective tissue diseases such as SLE, Progressive Systemic Sclerosis, Mixed Connective Tissue Diseases, Sjogren’s Syndrome, and Polymyositis.

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/K994071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994071: Rhigene Ana Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994071

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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