Cleared Traditional

K850056 - LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT

K850056 is an FDA 510(k) clearance for LEECO PROGESTERONE-QUANT DIAGNOSTIC TES..., manufactured by Leeco Diagnostics, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K850056

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.

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 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K850056.
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · Immuchem Corp. · Feb 1986
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
DIRIA-PROGK IMMUNOASSAY
K832694 · Sorin Biomedica, Fiat, USA, Inc. · Jan 1984
IMMO PHASE DIRECT PROGESTERONE RADIO-
K830880 · Corning Medical & Scientific · Apr 1983