510(k) Report

510(k) · Cleared

Cleared

Ideia Pce Chlamydia

K033865510(k) SpecialCleared Jan 21, 200440-day reviewClass I21 CFR 866.3120

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

Dakocytomation, Ltd. · LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Cleared on Jan 21, 2004 after a 40-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 21, 2004
Review
40 days
Class
Class I
Product code
LJC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K033865Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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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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 LJC devices

LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJC

FDA has decided no LJC device since 2007.

Median 510(k) review, days · LJC

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

Recalls per year · LJC

1in 2025

2008: 22011: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LJC

1in 2019

2018: 22019: 1
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LJC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—20
20090—00
20100—00
20110—10
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—02
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

What is it indicated for?

DakoCytomation Ltd IDEIA T M PCEChlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in LJC

The LJC category page

  • K032330CT OIAThermo Biostar, Inc. · 2004
  • K033079Chlamydia Igg Elisa Test SystemTrinity Biotech USA · 2003
  • K982210Modification of Syva Microtrak II Chlamydia EiaDade Behring, Inc. · 1998
  • K962558Chlamydia Igg Elisa Test SystemArmkel, LLC · 1997
  • K960850Access Chlamydia AssayBio-Rad Laboratories, Inc. · 1997

https://510kreport.com/device/K033865 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033865: Ideia Pce Chlamydia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033865

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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