Cleared Traditional

K863422 - DELFIA(TM) CORTISOL KIT

K863422 is the FDA 510(k) clearance for DELFIA(TM) CORTISOL KIT by Lkb Instruments, Inc.. It is a Class 2 Chemistry device (product code JFT) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K863422 · Lkb Instruments, Inc. · Chemistry device
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Sep 1986
Decision
22d
Days
Class 2
Risk

K863422 is an FDA 510(k) clearance for the DELFIA(TM) CORTISOL KIT. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lkb Instruments, Inc. devices

Submission Details

510(k) Number K863422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date September 26, 1986
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K863422.
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1990
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989
CEDIA CORTISOL ASSAY
K893954 · Microgenics Corp. · Oct 1989
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985
TDX CORTISOL
K852927 · Abbott Laboratories · Aug 1985
SYVA ADVANCE CORTISOL ASSAY
K833932 · Syva Co. · Dec 1983