Cleared Traditional

K820357 - LUTEINIZING HORMONE KIT

K820357 is an FDA 510(k) clearance for LUTEINIZING HORMONE KIT, manufactured by Pcl-Ria, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K820357 · Pcl-Ria, Inc. · Chemistry device
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Mar 1982
Decision
44d
Days
Class 1
Risk

K820357 is an FDA 510(k) clearance for the LUTEINIZING HORMONE KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 44 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 Pcl-Ria, Inc. devices

FDA 510(k) Submission Details - K820357

510(k) Number K820357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1982
Decision Date March 25, 1982
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
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 K820357.
QUANTIMUNE HLH RIA
K821346 · Bio-Rad · May 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · Monobind · Apr 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753 · Amersham Corp. · Apr 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
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · Leeco Diagnostics, Inc. · Mar 1981