Cleared Traditional

K830880 - IMMO PHASE DIRECT PROGESTERONE RADIO-

K830880 is an FDA 510(k) clearance for IMMO PHASE DIRECT PROGESTERONE RADIO-, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K830880 · Corning Medical & Scientific · Chemistry device
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Apr 1983
Decision
31d
Days
Class 1
Risk

K830880 is an FDA 510(k) clearance for the IMMO PHASE DIRECT PROGESTERONE RADIO-. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 31 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 Corning Medical & Scientific devices

FDA 510(k) Submission Details - K830880

510(k) Number K830880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date April 18, 1983
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K830880.
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · Leeco Diagnostics, Inc. · Feb 1985
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
K845026 · Amersham Corp. · Feb 1985
DIRIA-PROGK IMMUNOASSAY
K832694 · Sorin Biomedica, Fiat, USA, Inc. · Jan 1984
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · Diagnostic Products Corp. · Mar 1982
PROGESTERONE KIT BY RIA
K813484 · Immuchem Corp. · Dec 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · Immunalysis Corporation · Jul 1981