Cleared Traditional

OPUS PROGESTERONE (K971725) - FDA 510(k) Clearance

Class I Chemistry device.

K971725 · Behring Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
40d
Days
Class 1
Risk

K971725 is an FDA 510(k) clearance for the OPUS PROGESTERONE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on June 18, 1997 after a review of 40 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K971725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1997
Decision Date June 18, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 56
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K971725.
ELECSYS PROGESTERONE ASSAY
K964841 · Boehringer Mannheim Corp. · Mar 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · bioMerieux, Inc. · Jan 1997
AXSYM PROGESTERONE
K955025 · Abbott Laboratories · Mar 1996
IMMULITE PROGESTERONE
K944211 · Diagnostic Products Corp. · Dec 1994
IMMULITE PROGESTERONE
K935138 · Diagnostic Products Corp. · Jan 1994
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992