Cleared Traditional

RIA-GNOST INSULIN (K890837) - FDA 510(k) Clearance

Class I Chemistry device.

K890837 · Cambridge Medical Technology · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
64d
Days
Class 1
Risk

K890837 is an FDA 510(k) clearance for the RIA-GNOST INSULIN. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Cambridge Medical Technology (Billerica, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 64 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 Cambridge Medical Technology devices

Submission Details

510(k) Number K890837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date April 26, 1989
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 26
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K890837.
IMX INSULIN
K920109 · Abbott Laboratories · May 1992
ENZYMUN TEST(R) INSULIN
K901135 · Boehringer Mannheim Corp. · Apr 1990
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