Cleared Traditional

K850056 - LEECO PROGESTERONE-QUANT DIAGNOSTIC TES...

K850056 is the FDA 510(k) clearance for LEECO PROGESTERONE-QUANT DIAGNOSTIC TES... by Leeco Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JLS) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850056 · Leeco Diagnostics, Inc. · Chemistry device
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Feb 1985
Decision
29d
Days
Class 1
Risk

K850056 is an FDA 510(k) clearance for the LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 29 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K850056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date February 06, 1985
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 32
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K850056.
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · Amersham Corp. · Feb 1987
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
K845026 · Amersham Corp. · Feb 1985
IMMO PHASE DIRECT PROGESTERONE RADIO-
K830880 · Corning Medical & Scientific · Apr 1983
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · Diagnostic Products Corp. · Mar 1982