# K972129: Chlamydiatrol AG

- Pathway: 510(k) (Traditional)
- Applicant: Blackhawk Biosystems, Inc.
- Decided: Aug 12, 1997 after 67 days
- Product code: MJZ (Kit, Direct Antigen, Positive Control)
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K972129
Methodology: https://510kreport.com/methodology