Cleared Traditional

K961206 - OPUS T3 CONTROLS

K961206 is the FDA 510(k) clearance for OPUS T3 CONTROLS by Behring Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K961206 · Behring Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
27d
Days
Class 1
Risk

K961206 is an FDA 510(k) clearance for the OPUS T3 CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K961206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date April 23, 1996
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K961206.
OPUS B12 CONTROLS
K962694 · Behring Diagnostics, Inc. · Jul 1996
ACS FRT4 IMMUNOASSAY
K961510 · Ciba Corning Diagnostics Corp. · Jun 1996
COMPLEMENT CONTROL
K960874 · Wako Chemicals USA, Inc. · Jun 1996
PSA CONTROLS
K960154 · Diagnostic Products Corp. · Mar 1996
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
K955796 · Data Medical Associates, Inc. · Feb 1996
OPUS PROLACTIN CONTROLS
K955468 · Behring Diagnostics, Inc. · Feb 1996