Cleared Traditional

K872727 - LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT

K872727 is the FDA 510(k) clearance for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT by Serono Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K872727 · Serono Diagnostics, Inc. · Chemistry device
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Aug 1987
Decision
28d
Days
Class 1
Risk

K872727 is an FDA 510(k) clearance for the LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on August 5, 1987 after a review of 28 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K872727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date August 05, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K872727.
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · American Dade · Sep 1987
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K872131 · Hybritech, Inc. · Aug 1987
CLEARPLAN
K871332 · Unipath , Ltd. · Aug 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · Diagnostic Products Corp. · Feb 1987
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929 · Terumo Medical Corp. · Nov 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986