Cleared Traditional

K952075 - PROGESTERONE ASSAY FOR THE TECHNICON IM...

K952075 is the FDA 510(k) clearance for PROGESTERONE ASSAY FOR THE TECHNICON IM... by Bayer Corp.. It is a Class 1 Chemistry device (product code JLS) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K952075 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
41d
Days
Class 1
Risk

K952075 is an FDA 510(k) clearance for the PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 41 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 Bayer Corp. devices

Submission Details

510(k) Number K952075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1995
Decision Date June 13, 1995
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 31
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K952075.
VIDAS PROESTERONE (PRG) (30 409)
K965084 · bioMerieux, Inc. · Jan 1997
AXSYM PROGESTERONE
K955025 · Abbott Laboratories · Mar 1996
ACCESS PROGESTERONE ASSAY
K955769 · Bio-Rad Laboratories, Inc. · Feb 1996
AURAFLEX PROGESTERONE 150TEST PACK
K951630 · Organon Teknika Corp. · May 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570 · Baxter Diagnostics, Inc. · Apr 1995
IMMULITE PROGESTERONE
K944211 · Diagnostic Products Corp. · Dec 1994