Cleared Traditional

K852146 - QUIDEL QUEST OVULATION TEST

K852146 is an FDA 510(k) clearance for QUIDEL QUEST OVULATION TEST, manufactured by Quidel Corp.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K852146 · Quidel Corp. · Chemistry device
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Jul 1985
Decision
74d
Days
Class 1
Risk

K852146 is an FDA 510(k) clearance for the QUIDEL QUEST OVULATION TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 74 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 Quidel Corp. devices

FDA 510(k) Submission Details - K852146

510(k) Number K852146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1985
Decision Date July 29, 1985
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 98
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K852146.
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K860308 · Boots-Celltech Diagnostics, Inc. · Mar 1986
DELFIA TM HLH KIT
K855173 · Lkb Instruments, Inc. · Feb 1986
LEE-BEAD BETA LH (EIA)
K854838 · Leeco Diagnostics, Inc. · Jan 1986
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · Amersham Corp. · Apr 1985
LH RIA
K842445 · Syncor Intl. Corp. · Sep 1984
MICROMEDIC LH & FSH RIA KIT
K840188 · Micromedic Systems · Mar 1984