Cleared Traditional

K965109 - ELECSYS ESTRADIOL ASSAY

K965109 is an FDA 510(k) clearance for ELECSYS ESTRADIOL ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K965109 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
60d
Days
Class 1
Risk

K965109 is an FDA 510(k) clearance for the ELECSYS ESTRADIOL ASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on February 18, 1997 after a review of 60 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K965109

510(k) Number K965109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date February 18, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

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 32
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K965109.
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc. · Oct 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
K970643 · Johnson & Johnson Clinical Diagnostics, Inc. · Mar 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · Bio-Rad Laboratories, Inc. · Feb 1997
VIDAS ESTRADIOL II (E2II) ASSAY
K955647 · Biomerieux Vitek, Inc. · Feb 1996
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · Ciba Corning Diagnostics Corp. · Dec 1995
ULTRA-SENSITIVE ESTRADIOL
K953605 · Diagnostic Systems Laboratories, Inc. · Oct 1995