Cleared Traditional

K913162 - ENZYMUN-TEST ESTRADIOL

K913162 is an FDA 510(k) clearance for ENZYMUN-TEST ESTRADIOL, 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 72-day FDA review.

K913162 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
72d
Days
Class 1
Risk

K913162 is an FDA 510(k) clearance for the ENZYMUN-TEST ESTRADIOL. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 72 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 - K913162

510(k) Number K913162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1991
Decision Date September 27, 1991
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
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 K913162.
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498 · Biomerieux Vitek, Inc. · Feb 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp. · Jul 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991
MODIFIED DELFIA ESTRADIOL KIT
K902358 · Pharmacia, Inc. · Jun 1990