Cleared Traditional

K791405 - 125I LEUTINIZING HORMONE RIA KIT

K791405 is an FDA 510(k) clearance for 125I LEUTINIZING HORMONE RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K791405 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
48d
Days
Class 1
Risk

K791405 is an FDA 510(k) clearance for the 125I LEUTINIZING HORMONE RIA KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 48 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K791405

510(k) Number K791405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1979
Decision Date September 17, 1979
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K791405.
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278 · Immuno Nuclear Corp. · Jan 1981
CENTRIA LH RIA
K792350 · Union Carbide Corp. · Jan 1980
RIA KIT, LH
K781685 · Amersham Corp. · Oct 1978
125-I LABELED HUMAN LUTEINIZING HORMONE
K780576 · Pcl-Ria, Inc. · May 1978
RIA SYS. FOR HUMAN LUTEINIZING HORMONE
K780367 · Calbiochem-Behring Corp. · Apr 1978