Cleared Traditional

RIA, INSULIN, DOUBLE ANTIBODY (K790630) - FDA 510(k) Clearance

Class I Chemistry device.

K790630 · Endocrine-Metabolic Center · Chemistry device
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Jul 1979
Decision
119d
Days
Class 1
Risk

K790630 is an FDA 510(k) clearance for the RIA, INSULIN, DOUBLE ANTIBODY. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Endocrine-Metabolic Center (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Endocrine-Metabolic Center devices

Submission Details

510(k) Number K790630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date July 24, 1979
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
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

Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K790630.
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · Helena Laboratories · Jan 1990
COAT-A-COUNT INSULIN KIT
K821861 · Diagnostic Products Corp. · Jul 1982
ARIA II INSULIN RIA
K811144 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981
NSULIN RIA KIT 125I
K771628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977