Cleared Traditional

K920920 - ELISA TUBE LH TEST KIT

K920920 is an FDA 510(k) clearance for ELISA TUBE LH TEST KIT, manufactured by Bio Clinic Co.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K920920 · Bio Clinic Co. · Chemistry device
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Apr 1992
Decision
40d
Days
Class 1
Risk

K920920 is an FDA 510(k) clearance for the ELISA TUBE LH TEST KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bio Clinic Co. (St. Louis, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 40 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 Clinic Co. devices

FDA 510(k) Submission Details - K920920

510(k) Number K920920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date April 08, 1992
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 102
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K920920.
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · Vitek Systems, Inc. · Apr 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · Quidel Corp. · Mar 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · Medix Biotech, Inc. · Mar 1992