FDA WARNING_LETTER - DRG Instruments GmbH - November 07, 2024

The FDA issued a Warning Letter to DRG Instruments GmbH following a November 4-7, 2024, inspection in Marburg, Germany. The firm manufactures in vitro diagnostic devices, including the Salivary Cortisol ELISA (REF No. SLV-2930) and Salivary Cortisol ELISA RUO (REF No. SLV-2930R).

The Salivary Cortisol ELISA and Salivary Cortisol ELISA RUO are deemed adulterated and misbranded. The firm failed to submit a new premarket notification (510(k)) for significant changes to the Salivary Cortisol ELISA (K051733), including a new monoclonal antibody and a narrower assay measuring range (0.09-30 ng/mL vs. 0.537-80 ng/mL). This change could lead to inaccurate results and misdiagnosis. The Salivary Cortisol ELISA RUO is marketed for research but appears intended for clinical diagnostic use, requiring a 510(k) or PMA.

Quality System Regulation (QSR) violations include inadequate corrective and preventive action procedures (21 CFR 820.100(a)), specifically regarding CAPA No. 2024-14 for the Salivary Testosterone ELISA. Complaint investigation records (21 CFR 820.198(e)) lacked required information like UDI/UPC, complainant