510(k) · Cleared
ClearedChlamydiatrol AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackhawk Biosystems, Inc. · MJZ Kit, Direct Antigen, Positive Control
Cleared on Aug 12, 1997 after a 67-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Aug 12, 1997
- Review
- 67 days
- Class
- Class I
- Product code
- MJZ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 MJZ? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K930033 | VIROTROL HIV-1 Ag The summary prints BK930033, a CBER number, which our reading took as K930033, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 3…nstructions supplied by the manufacturer of the test kit being used. Substanial Equivalence ChlamydiaTrol Ag reagent is substantially equivalent to VIROTROL HIV-1 Ag (BK930033) unassayed virology control manufactured and distributed by Blackhawk 2.0 3.0 BioSystems, Inc. in that they are… |
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 MJZ devicesMJZ Kit, Direct Antigen, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · MJZ
Too few MJZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MJZ
No recall names MJZ since 2007.
Adverse event reports per year · MJZ
No MAUDE report names MJZ 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 | — | 0 | 0 |
| 2009 | 1 | — | 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 ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Ag reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.
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/K972129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972129: Chlamydiatrol AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972129
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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