Cleared Traditional

K844767 - RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA ...

K844767 is the FDA 510(k) clearance for RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA ... by Biotecx Laboratories, Inc.. It is a Class 1 Chemistry device (product code CGI) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844767 · Biotecx Laboratories, Inc. · Chemistry device
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Feb 1985
Decision
56d
Days
Class 1
Risk

K844767 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1265 - 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 Biotecx Laboratories, Inc. devices

Submission Details

510(k) Number K844767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1984
Decision Date February 01, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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 - CGI Radioimmunoassay, Estriol

All 26
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K844767.
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576 · Eastman Kodak Company · Mar 1992
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · Immunotech Corp. · Aug 1990
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · Sclavo, Inc. · Apr 1986
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · Amersham Corp. · Dec 1984
ENDAB ESTRIOL UNCONJUGATED
K840902 · Immunotech Corp. · Apr 1984