Cleared Traditional

K910683 - ENZYMUN-TEST PROGESTERONE

K910683 is an FDA 510(k) clearance for ENZYMUN-TEST PROGESTERONE, 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 48-day FDA review.

K910683 · Boehringer Mannheim Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1991
Decision
48d
Days
Class 1
Risk

K910683 is an FDA 510(k) clearance for the ENZYMUN-TEST PROGESTERONE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 48 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K910683

510(k) Number K910683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date April 08, 1991
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K910683.
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · Ciba Corning Diagnostics Corp. · Aug 1993
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
DELFIA PROGESTERONE KIT
K890428 · Pharmacia, Inc. · Feb 1989
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · Amersham Corp. · Apr 1988