Cleared Traditional

K860538 - RIGHT-DAY URINARY LH (EIA)

K860538 is an FDA 510(k) clearance for RIGHT-DAY URINARY LH (EIA), 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 167-day FDA review.

K860538 · Leeco Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
167d
Days
Class 1
Risk

K860538 is an FDA 510(k) clearance for the RIGHT-DAY URINARY LH (EIA). 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 July 29, 1986 after a review of 167 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.

FDA 510(k) Submission Details - K860538

510(k) Number K860538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date July 29, 1986
Days to Decision 167 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
78d slower than avg
Panel avg: 89d · This submission: 167d
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 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K860538.
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · Leeco Diagnostics, Inc. · Sep 1986
FORETEL, COLOR OVULATION TEST
K860828 · Nms Pharmaceuticals, Inc. · Aug 1986
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
K862180 · Clinetics Corp. · Jul 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · Hybritech, Inc. · Apr 1986
MICRO-ELISA HLH TEST KIT MONOCLONAL
K860333 · Bioclinical Systems, Inc. · Apr 1986
K860538 · RIGHT-DAY URINARY LH (EIA)
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