Cleared Traditional

IMMULITE PROGESTERONE (K935138) - FDA 510(k) Clearance

Class I Chemistry device.

K935138 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
75d
Days
Class 1
Risk

K935138 is an FDA 510(k) clearance for the IMMULITE PROGESTERONE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 75 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K935138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date January 11, 1994
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
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 K935138.
ELECSYS PROGESTERONE ASSAY
K964841 · Boehringer Mannheim Corp. · Mar 1997
AXSYM PROGESTERONE
K955025 · Abbott Laboratories · Mar 1996
IMMULITE PROGESTERONE
K944211 · Diagnostic Products Corp. · Dec 1994
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991