Cleared Traditional

K914462 - SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG...

K914462 is the FDA 510(k) clearance for SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG... by Serono-Baker Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JLS) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K914462 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Oct 1991
Decision
16d
Days
Class 1
Risk

K914462 is an FDA 510(k) clearance for the SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS). Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - 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

Submission Details

510(k) Number K914462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1991
Decision Date October 23, 1991
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 33
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K914462.
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
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AFFINITY PRG
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MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
DELFIA PROGESTERONE KIT
K890428 · Pharmacia, Inc. · Feb 1989