510(k) · Cleared
ClearedDiagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · LJP Antiserum, Fluorescent, Chlamydia Trachomatis
Cleared on Sep 24, 2007 as substantially equivalent to K864389 (American Micro Scan, 1986) and 2 other predicates after a 287-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Sep 24, 2007
- Review
- 287 days
- Class
- Class I
- Product code
- LJP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K864389 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864389 Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 1986
- This deviceK063675 Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitDiagnostic Hybrids, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864389 | Chlamydiae Flourescent Monoclonal Antibody Test | American Micro Scan | 1986 | — |
| 0 (this device) | K063675 | Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit | Diagnostic Hybrids, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
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 LJP? 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864389 | Chlamydiae Flourescent Monoclonal Antibody TestSummary page 1…product code LJP) Legally marketed devices American Microscan (distributed by Trinity Biotech) DFA Chlamydia to which equivalence is K864389 Detection Kit claimed: K864663 Kallestad (distributed by BioRad) Pathfinder®… | 1986 |
| * | K864663 | Pathfinder Chlamydia Culture Confirmation SystemSummary page 1…croscan (distributed by Trinity Biotech) DFA Chlamydia to which equivalence is K864389 Detection Kit claimed: K864663 Kallestad (distributed by BioRad) Pathfinder® Chlamydia Culture Confirmatio… | 1987 |
| * | K895839 | Pathodx Chlamydia Culture Confirmation PKCC1Summary page 1…estad (distributed by BioRad) Pathfinder® Chlamydia Culture Confirmation Kit/System K895839 Diagnostic Products, Corp. (distributed by Remel) PathoDx® Chlamydia Cultur… | 1990 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All LJP devicesLJP Antiserum, Fluorescent, Chlamydia Trachomatis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJP
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · LJP
Too few LJP 510(k)s in any year since 2007 to give a median.
Recalls per year · LJP
No recall names LJP since 2007.
Adverse event reports per year · LJP
No MAUDE report names LJP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 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 | 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 Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
Performance has not been established with direct patient specimens.
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/K063675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063675: Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063675
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026