510(k) Report

510(k) · Cleared

Cleared

CT OIA

K032330510(k) TraditionalCleared Mar 2, 2004217-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

Thermo Biostar, Inc. · LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Cleared on Mar 2, 2004 after a 217-day review. The FDA summary names its predicate without a number.

Decided
Mar 2, 2004
Review
217 days
Class
Class I
Product code
LJC
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K032330Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LJC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Thermo Biostar Chlamydia OIA
Named without a submission number
—

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?

The Thermo Electron CT OIA assay is an Optical InmunoAssay (OlA) test for the rapid, qualitative detection of chlamydial antigen from female endocervical swab specimens. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Chlamydia trachomatis antigen. The assay is intended for in vitro diagnostic use with symptomatic females in populations at risk for sexually transmitted diseases. CT OIA test results are…

Read the full statement (124 words)

The Thermo Electron CT OIA assay is an Optical InmunoAssay (OlA) test for the rapid, qualitative detection of chlamydial antigen from female endocervical swab specimens. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Chlamydia trachomatis antigen. The assay is intended for in vitro diagnostic use with symptomatic females in populations at risk for sexually transmitted diseases.

CT OIA test results are presumptive evidence for either the presence or absence of C. trachomatis. Definitive laboratory evidence for the presence/ absence of C. trachomatis would need additional testing. CT OIA test results should not preclude empiric treatment of women with overt symptoms of PID. Performance for use in asymptomatic male and female populations has not been established.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Thermo Biostar, Inc.

5 FDA decisions under this applicant name. See the company

  • K023947GC OIAThermo Biostar, Inc. · 2003
  • K023556Flu Oia a/B Test KitThermo Biostar, Inc. · 20031 recall
  • K023779RSV OiaThermo Biostar, Inc. · 2003
  • K021172RSV OiaThermo Biostar, Inc. · 2002

Recent decisions in LJC

The LJC category page

  • K033865Ideia Pce ChlamydiaDakocytomation, Ltd. · 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/K032330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032330: CT OIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032330

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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