# K972904: Document Molecular Pathology Chlamydia Trachomatis Control

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Feb 20, 1998 after 198 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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 FDA summary names its predicate without a number.
- (no number) Abbott LCx Chlamydia Negative Control: named in the summary without a submission number
- (no number) Urine, Human, Positive for Chlamydia trachomatis, as recommended in the package insert for the Abbott Chlamydia Amplification Kit: named in the summary without a submission number

## Indications for use
This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis. This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have be&r set at appropriate positive (+) and negative (-) levels. This product is intended for in vitro use only.

Source page: https://510kreport.com/device/K972904
Methodology: https://510kreport.com/methodology