Cleared Traditional

K841545 - ENZYME IMMUNOASSAY FOR DETECTION HORM

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

K841545 · Btc Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K841545

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.

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 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 QUIK RIA KIT
K840174 · Pacific Biotech, Inc. · Mar 1984