Cleared Traditional

K964841 - ELECSYS PROGESTERONE ASSAY

K964841 is an FDA 510(k) clearance for ELECSYS PROGESTERONE ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K964841 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
111d
Days
Class 1
Risk

K964841 is an FDA 510(k) clearance for the ELECSYS PROGESTERONE ASSAY. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on March 24, 1997 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K964841

510(k) Number K964841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date March 24, 1997
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

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 32
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K964841.
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133 · Johnson & Johnson Clinical Diagnostics, Inc. · Jun 1997
OPUS PROGESTERONE
K971725 · Behring Diagnostics, Inc. · Jun 1997
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
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
K952075 · Bayer Corp. · Jun 1995