Cleared Traditional

K810662 - LEECO LH-QUANT DIAGNOSTIC KIT

K810662 is an FDA 510(k) clearance for LEECO LH-QUANT DIAGNOSTIC KIT, 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 20-day FDA review.

K810662 · Leeco Diagnostics, Inc. · Chemistry device
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Mar 1981
Decision
20d
Days
Class 1
Risk

K810662 is an FDA 510(k) clearance for the LEECO LH-QUANT DIAGNOSTIC KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 20 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 Leeco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K810662

510(k) Number K810662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1981
Decision Date March 31, 1981
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 K810662.
LUTEINIZING HORMONE KIT
K820357 · Pcl-Ria, Inc. · Mar 1982
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K813213 · Intl. Immunoassay Laboratories, Inc. · Dec 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · Immunalysis Corporation · May 1981
LUTEINIZING HORMONE
K810741 · Pcl-Ria, Inc. · Mar 1981
LUTENIZING HORMONES
K810754 · Pcl-Ria, Inc. · Mar 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981