Cleared Traditional

K821346 - QUANTIMUNE HLH RIA

K821346 is the FDA 510(k) clearance for QUANTIMUNE HLH RIA by Bio-Rad. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821346 · Bio-Rad · Chemistry device
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May 1982
Decision
23d
Days
Class 1
Risk

K821346 is an FDA 510(k) clearance for the QUANTIMUNE HLH RIA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 23 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 Bio-Rad devices

Submission Details

510(k) Number K821346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1982
Decision Date May 28, 1982
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 68
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K821346.
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · Amersham Corp. · Apr 1985
MICROMEDIC LH & FSH RIA KIT
K840188 · Micromedic Systems · Mar 1984
LH (125I) RADIOIMMUNOASSAY
K822288 · Corning Medical & Scientific · Sep 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753 · Amersham Corp. · Apr 1982
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · Immunalysis Corporation · May 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · Leeco Diagnostics, Inc. · Mar 1981