Cleared Traditional

K861354 - RIGHT-DAY OVULATION HOME TEST

K861354 is the FDA 510(k) clearance for RIGHT-DAY OVULATION HOME TEST by Leeco Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K861354 · Leeco Diagnostics, Inc. · Chemistry device
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Sep 1986
Decision
159d
Days
Class 1
Risk

K861354 is an FDA 510(k) clearance for the RIGHT-DAY OVULATION HOME TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 159 days - an extended review 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: 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K861354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1986
Decision Date September 16, 1986
Days to Decision 159 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
71d slower than avg
Panel avg: 88d · This submission: 159d
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 K861354.
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K863934 · Diagnostic Products Corp. · Feb 1987
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ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · Leeco Diagnostics, Inc. · Jul 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · Hybritech, Inc. · Apr 1986
DELFIA TM HLH KIT
K855173 · Lkb Instruments, Inc. · Feb 1986