Cleared Traditional

K895421 - CORTISOL TEST SYSTEM

K895421 is the FDA 510(k) clearance for CORTISOL TEST SYSTEM by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code JFT) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K895421 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 17
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K895421.
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · Biomerieux Vitek, Inc. · Jul 1993
ACCESS(R) CORTISOL REAGENTS
K926322 · Bio-Rad Laboratories, Inc. · May 1993
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1990
CEDIA CORTISOL ASSAY
K893954 · Microgenics Corp. · Oct 1989
DELFIA(TM) CORTISOL KIT
K863422 · Lkb Instruments, Inc. · Sep 1986
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985