Cleared Traditional

RSL (125 L) PROGESTERONE KIT (K800126) - FDA 510(k) Clearance

Class I Chemistry device.

K800126 · Radioassay Systems Laboratories, Inc. · Chemistry device
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Feb 1980
Decision
26d
Days
Class 1
Risk

K800126 is an FDA 510(k) clearance for the RSL (125 L) PROGESTERONE KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 26 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 Radioassay Systems Laboratories, Inc. devices

Submission Details

510(k) Number K800126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 10
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K800126.
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · Diagnostic Products Corp. · Mar 1982
REAGENT SYSTEM, PROGESTERONE, ARIA
K770732 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977