# FDA WARNING_LETTER - DRG Instruments GmbH - November 07, 2024

Source: https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/51bbefc6-dc80-4832-abad-5469bb43fafb

> FDA WARNING_LETTER for DRG Instruments GmbH on November 07, 2024. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: DRG Instruments GmbH
- Inspection Date: 2024-11-07
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2016-10-28](https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/f83880cb-3137-41a7-a911-c959bb809db4)

## Related Officers

- [Simon W. Huang](https://www.keypedia.com/people/simon-w-huang/51d2f973-1597-4ec7-8c08-e75c58549f4e)
- [Stephen A. Baliani](https://www.keypedia.com/people/stephen-a-baliani/54bfe8a7-ae91-410c-9c3c-3b74a6530543)
- [Acting Director](https://www.keypedia.com/people/courtney-h-lias/5e0a64fa-0140-4de2-9eed-929b12def9e9)
- [Ina Hairston](https://www.keypedia.com/people/ina-hairston/d84c9134-9335-42bf-a0eb-12b0c21bc4a6)

Company: https://www.keypedia.com/companies/drg-instruments-gmbh/5a8981ef-7bb3-4af6-a73f-01be1234ce51

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7