Cleared Traditional

K911396 - SR1 ESTRADIOL ENZYME IMMUNOASSAY

K911396 is an FDA 510(k) clearance for SR1 ESTRADIOL ENZYME IMMUNOASSAY, manufactured by Serono-Baker Diagnostics, Inc.. 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.

K911396 · Serono-Baker Diagnostics, Inc. · Chemistry device
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May 1991
Decision
60d
Days
Class 1
Risk

K911396 is an FDA 510(k) clearance for the SR1 ESTRADIOL ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on May 28, 1991 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 Serono-Baker Diagnostics, Inc. devices

FDA 510(k) Submission Details - K911396

510(k) Number K911396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date May 28, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
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 42
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K911396.
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp. · Jul 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318 · Serono-Baker Diagnostics, Inc. · Jul 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991
MODIFIED DELFIA ESTRADIOL KIT
K902358 · Pharmacia, Inc. · Jun 1990
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145 · Serono-Baker Diagnostics, Inc. · Dec 1989