Psychemedic lowers cutoff for hair testing
Psychemedics has filed to change the test cutoff and method for their THC-COOH screen. Previously they used radioimmunoassay (RIA) at 20 pg/10 mg of hair. The new system uses Enzyme Immunoassay (EIA) at 10 pg/10 mg hair.
This is the initial screen (immunoassay). GC/MS/MS is still shown as method of confirmation.
FDA 510(k) filing.
Psychemedic lowers cutoff for hair testing
Quote:
Originally Posted by DrBill100
Psychemedics has filed to change the test cutoff and method for their THC-COOH screen. Previously they used radioimmunoassay (RIA) at 20 pg/10 mg of hair. The new system uses Enzyme Immunoassay (EIA) at 10 pg/10 mg hair.
This is the initial screen (immunoassay). GC/MS/MS is still shown as method of confirmation.
FDA 510(k) filing.
Did they get it changed? And if so when did it go into effect?