Cleared Traditional

K772281 - RSL INSULIN KIT

K772281 is the FDA 510(k) clearance for RSL INSULIN KIT by Radioassay Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CFP) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K772281 · Radioassay Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1978
Decision
25d
Days
Class 1
Risk

K772281 is an FDA 510(k) clearance for the RSL INSULIN KIT. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1978 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1405 - 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 K772281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1977
Decision Date January 06, 1978
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFP Radioimmunoassay, Immunoreactive Insulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1405
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 - CFP Radioimmunoassay, Immunoreactive Insulin

All 17
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K772281.
AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM
K792279 · Micromedic Systems · Dec 1979
CENTRIA INSULIN RIA
K791707 · Ventrex Laboratories, Inc. · Oct 1979
INSULIN AUTOPAK
K781086 · Micromedic Systems · Aug 1978
CENTRIA INSULIN RIA
K771979 · Union Carbide Corp. · Nov 1977
NSULIN RIA KIT 125I
K771628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977