Cleared Traditional

K780576 - 125-I LABELED HUMAN LUTEINIZING HORMONE

K780576 is the FDA 510(k) clearance for 125-I LABELED HUMAN LUTEINIZING HORMONE by Pcl-Ria, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K780576 · Pcl-Ria, Inc. · Chemistry device
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May 1978
Decision
39d
Days
Class 1
Risk

K780576 is an FDA 510(k) clearance for the 125-I LABELED HUMAN LUTEINIZING HORMONE. 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 May 19, 1978 after a review of 39 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

Submission Details

510(k) Number K780576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date May 19, 1978
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 76
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K780576.
CENTRIA LH RIA
K792350 · Union Carbide Corp. · Jan 1980
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp. · Sep 1979
RIA KIT, LH
K781685 · Amersham Corp. · Oct 1978
RIA SYS. FOR HUMAN LUTEINIZING HORMONE
K780367 · Calbiochem-Behring Corp. · Apr 1978
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
K770854 · Nichols Institute Diagnostics · May 1977