Cleared Traditional

K861354 - RIGHT-DAY OVULATION HOME TEST

K861354 is an FDA 510(k) clearance for RIGHT-DAY OVULATION HOME TEST, manufactured by Leeco Diagnostics, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K861354

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.

CEP Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K861354.
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144 · Immuchem Corp. · Nov 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929 · Terumo Medical Corp. · Nov 1986
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
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K860308 · Boots-Celltech Diagnostics, Inc. · Mar 1986