Cleared Traditional

K860984 - TANDEM ICON LH ASSAY (URINE) IMMUNOENZY...

K860984 is the FDA 510(k) clearance for TANDEM ICON LH ASSAY (URINE) IMMUNOENZY... by Hybritech, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K860984 · Hybritech, Inc. · Chemistry device
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Apr 1986
Decision
43d
Days
Class 1
Risk

K860984 is an FDA 510(k) clearance for the TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on April 29, 1986 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 Hybritech, Inc. devices

Submission Details

510(k) Number K860984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1986
Decision Date April 29, 1986
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 68
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K860984.
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · Leeco Diagnostics, Inc. · Sep 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · Leeco Diagnostics, Inc. · Jul 1986
DELFIA TM HLH KIT
K855173 · Lkb Instruments, Inc. · Feb 1986
LEE-BEAD BETA LH (EIA)
K854838 · Leeco Diagnostics, Inc. · Jan 1986
QUIDEL QUEST OVULATION TEST
K852146 · Quidel Corp. · Jul 1985