FDA product code NHG: Enzyme Immunoassay, Cortisol, Salivary
NHG is the FDA product code for enzyme immunoassay, cortisol, salivary. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under NHG, from 6 different applicants. The average 510(k) review took 216 days (median 197). FDA has posted 5 recalls for NHG devices, 3 initiated in the last five years.
Definition
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Cortisol, Salivary |
| Device class | Class II |
| Regulation | 21 CFR 862.1205 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NHG clearance
Top NHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Salimetrics, LLC | 2 | 2003-06-10 |
| Ibl International GmbH | 1 | 2015-11-25 |
| Pantex, Div. Bio-Analysis, Inc. | 1 | 2012-05-08 |
| Roche Diagnostics | 1 | 2007-10-05 |
| Drg Intl., Inc. | 1 | 2005-12-07 |
1 more applicants have NHG clearances. See the full list in Caduvo.
Most recent NHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150528 | Ibl International GmbH | Cortisol Saliva Luminescence Immunoassay | 2015-11-25 | 268 |
| K102841 | Pantex, Div. Bio-Analysis, Inc. | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | 2012-05-08 | 587 |
| K070788 | Roche Diagnostics | ELECSYS CORTISOL TEST SYSTEM | 2007-10-05 | 197 |
| K051733 | Drg Intl., Inc. | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | 2005-12-07 | 162 |
| K043175 | Roche Diagnostics Corp. | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | 2004-11-24 | 8 |
Recalls for NHG devices
5 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code NHG?
NHG is the FDA product code for enzyme immunoassay, cortisol, salivary. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel.
What device class is NHG?
Class II, regulation 21 CFR 862.1205. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHG?
Across 7 cleared submissions the average was 216 days from receipt to decision (median 197).
Which companies have the most NHG clearances?
Salimetrics, LLC (2); Ibl International GmbH (1); Pantex, Div. Bio-Analysis, Inc. (1); Roche Diagnostics (1); Drg Intl., Inc. (1).
Have NHG devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NHG
- Run a recall and safety report across every NHG manufacturer
- Watch product code NHG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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