Psychemedic lowers cutoff for hair testing

[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 (http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111929.pdf).

[mathesonfour]

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 (http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111929.pdf).

Did they get it changed? And if so when did it go into effect?