Cleared Traditional

ESTRADIOL DIRECT RIA KIT (K851540) - FDA 510(k) Clearance

Class I Chemistry device.

K851540 · Biotecx Laboratories, Inc. · Chemistry device
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Jun 1985
Decision
51d
Days
Class 1
Risk

K851540 is an FDA 510(k) clearance for the ESTRADIOL DIRECT RIA KIT. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on June 6, 1985 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 K851540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date June 06, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 49
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K851540.
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