Cleared Traditional

K895421 - CORTISOL TEST SYSTEM

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

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

FDA 510(k) Submission Details - K895421

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.

JFT Device Classification - Class 2, Special Controls

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 19
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