|Trade Name||RAPID FFN FOR THE TLI SYSTEM|
|Classification Name||enzyme immunoassay, fetal fibronectin|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following: 1) a change in the calibration procedure that allows for extended calibration, accomplished with a software modification and no longer requireing the use of the ffn positive reference calibrator; and 2) the addition of a quality control component, the tli qc cassette, for the tli analyzer coupled with a decrease in frequency of testing liquid controls.