Cleared Traditional

CORTISOL TEST SYSTEM (K895421) - FDA 510(k) Clearance

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

K895421 · Baxter Healthcare Corp · Chemistry device
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Dec 1989
Decision
97d
Days
Class 2
Risk

K895421 is an FDA 510(k) clearance for the CORTISOL TEST SYSTEM. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on December 7, 1989 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K895421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date December 07, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFT Fluorometric, Cortisol

All 7
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K895421.
ADVIA Centaur Cortisol (COR)
K192788 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
Elecsys Cortisol II, Cortisol II CalSet
K152227 · Roche Diagnostics · Apr 2016
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985
TDX CORTISOL
K852927 · Abbott Laboratories · Aug 1985
SYVA ADVANCE CORTISOL ASSAY
K833932 · Syva Co. · Dec 1983