Cleared Traditional

K841545 - ENZYME IMMUNOASSAY FOR DETECTION HORM

K841545 is the FDA 510(k) clearance for ENZYME IMMUNOASSAY FOR DETECTION HORM by Btc Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K841545 · Btc Diagnostics, Inc. · Chemistry device
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Nov 1984
Decision
225d
Days
Class 1
Risk

K841545 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY FOR DETECTION HORM. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Btc Diagnostics, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 225 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Btc Diagnostics, Inc. devices

Submission Details

510(k) Number K841545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date November 27, 1984
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 88d · This submission: 225d
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 72
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K841545.
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
LH RIA
K842445 · Syncor Intl. Corp. · Sep 1984
MICROMEDIC LH & FSH RIA KIT
K840188 · Micromedic Systems · Mar 1984
LH RIA
K833854 · Syncor Intl. Corp. · Jan 1984