Cleared Traditional

K862043 - DELFIA (TM) HFSH KIT

K862043 is the FDA 510(k) clearance for DELFIA (TM) HFSH KIT by Lkb Instruments, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K862043 · Lkb Instruments, Inc. · Chemistry device
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Jun 1986
Decision
27d
Days
Class 1
Risk

K862043 is an FDA 510(k) clearance for the DELFIA (TM) HFSH KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on June 24, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 K862043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date June 24, 1986
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 44
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K862043.
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · Hybritech, Inc. · Mar 1987
TERUMO SENSIBEAD EIA FSH KIT
K863928 · Terumo Medical Corp. · Dec 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · Nichols Institute Diagnostics · Oct 1986
LEE-BEAD BETA FSH (EIA)
K854837 · Leeco Diagnostics, Inc. · Jan 1986
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · Amersham Corp. · May 1985