Cleared Traditional

LUTEINIZING HORMONE RIA REAGENT, LH-RIA (K770854) - FDA 510(k) Clearance

Class I Immunology device.

K770854 · Nichols Institute Diagnostics · Immunology device
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May 1977
Decision
17d
Days
Class 1
Risk

K770854 is an FDA 510(k) clearance for the LUTEINIZING HORMONE RIA REAGENT, LH-RIA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (Mchenry, US). The FDA issued a Cleared decision on May 26, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1485 - the FDA immunology device 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K770854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1977
Decision Date May 26, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 104d · This submission: 17d
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 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K770854.
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp. · Jan 1997
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990