Cleared Traditional

K855173 - DELFIA TM HLH KIT

K855173 is the FDA 510(k) clearance for DELFIA TM HLH KIT by Lkb Instruments, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K855173 · Lkb Instruments, Inc. · Chemistry device
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Feb 1986
Decision
64d
Days
Class 1
Risk

K855173 is an FDA 510(k) clearance for the DELFIA TM HLH KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 64 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K855173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 28, 1986
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 67
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K855173.
RIGHT-DAY OVULATION HOME TEST
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RIGHT-DAY URINARY LH (EIA)
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TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · Hybritech, Inc. · Apr 1986
LEE-BEAD BETA LH (EIA)
K854838 · Leeco Diagnostics, Inc. · Jan 1986
QUIDEL QUEST OVULATION TEST
K852146 · Quidel Corp. · Jul 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · Amersham Corp. · Apr 1985