510(k) · Cleared
ClearedModification of Syva Microtrak II Chlamydia Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Cleared on Jul 9, 1998 after a 16-day review. The FDA summary names no predicate by number.
- Decided
- Jul 9, 1998
- Review
- 16 days
- Class
- Class I
- Product code
- LJC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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
What was it cleared against?
The FDA summary names no predicate by 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 devicesLJC 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJC
1in 2019
MAUDE reports naming product code LJC, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Syva MicroTrak II Chlamydia EIA is an enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens.
The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982210: Modification of Syva Microtrak II Chlamydia Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982210
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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