Cleared Traditional

K961276 - GASTRIN EIA MODEL 06B-555017

K961276 is an FDA 510(k) clearance for GASTRIN EIA MODEL 06B-555017, manufactured by Biosyn , Ltd.. The device is a Class 1 Chemistry device with product code CGC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K961276 · Biosyn , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
57d
Days
Class 1
Risk

K961276 is an FDA 510(k) clearance for the GASTRIN EIA MODEL 06B-555017. Classified as Radioimmunoassay, Gastrin (product code CGC), Class I - General Controls.

Submitted by Biosyn , Ltd. (Belfast, IE). The FDA issued a Cleared decision on May 30, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1325 - 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 Biosyn , Ltd. devices

FDA 510(k) Submission Details - K961276

510(k) Number K961276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1996
Decision Date May 30, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

CGC Device Classification - Class 1, General Controls

Product Code CGC Radioimmunoassay, Gastrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1325
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 - CGC Radioimmunoassay, Gastrin

All 7
Devices cleared under the same product code (CGC) and FDA review panel - the closest regulatory comparables to K961276.
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
K842079 · Immuno Nuclear Corp. · Jun 1984
GASTRIN RIA
K841963 · Syncor Intl. Corp. · Jun 1984
DPC GASTRIN KIT
K833489 · Diagnostic Products Corp. · Jan 1984
GASTRIN RADIOIMMUNOASSAY KIT (125-I)
K821175 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
K812727 · Immuno Nuclear Corp. · Nov 1981
GASTRIN RIA DIAGNOSTIC KIT
K812004 · Abbott Laboratories · Jul 1981