Cleared Traditional

K962694 - OPUS B12 CONTROLS

K962694 is an FDA 510(k) clearance for OPUS B12 CONTROLS, manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K962694 · Behring Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
11d
Days
Class 1
Risk

K962694 is an FDA 510(k) clearance for the OPUS B12 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 July 22, 1996 after a review of 11 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

FDA 510(k) Submission Details - K962694

510(k) Number K962694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date July 22, 1996
Days to Decision 11 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
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K962694.
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
K963085 · International Enzymes, Inc. · Aug 1996
OPUS MYOGLOBIN CONTROLS
K962841 · Behring Diagnostics, Inc. · Aug 1996
ELECSYS PRECICONTROL TSH
K962573 · Boehringer Mannheim Corp. · Jul 1996
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432 · Clinical Controls, Inc. · Jul 1996
ACS FRT4 IMMUNOASSAY
K961510 · Ciba Corning Diagnostics Corp. · Jun 1996
COMPLEMENT CONTROL
K960874 · Wako Chemicals USA, Inc. · Jun 1996