Cleared Traditional

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (K900010) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900010 · Kallestad Diag, A Div. of Erbamont, Inc. · Toxicology device
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Apr 1990
Decision
91d
Days
Class 2
Risk

K900010 is an FDA 510(k) clearance for the NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1205 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kallestad Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K900010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date April 03, 1990
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFT Fluorometric, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - JFT Fluorometric, Cortisol

All 19
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K900010.
Elecsys Cortisol III
K242505 · Roche Diagnostics · Jul 2025
ADVIA Centaur Cortisol (COR)
K192788 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985
TDX CORTISOL
K852927 · Abbott Laboratories · Aug 1985