Cleared Traditional

K813213 - SHARIA-LH RIA KIT FOR QUANTITATION HORMO

K813213 is the FDA 510(k) clearance for SHARIA-LH RIA KIT FOR QUANTITATION HORMO by Intl. Immunoassay Laboratories, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K813213 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Dec 1981
Decision
43d
Days
Class 1
Risk

K813213 is an FDA 510(k) clearance for the SHARIA-LH RIA KIT FOR QUANTITATION HORMO. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1981 after a review of 43 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 Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K813213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1981
Decision Date December 22, 1981
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K813213.
LH (125I) RADIOIMMUNOASSAY
K822288 · Corning Medical & Scientific · Sep 1982
QUANTIMUNE HLH RIA
K821346 · Bio-Rad · May 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
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981