Cleared Traditional

K961824 - COBAS INTEGRA REAGENT CASSETTES FOR ALB...

K961824 is the FDA 510(k) clearance for COBAS INTEGRA REAGENT CASSETTES FOR ALB... by Roche Diagnostic Systems, Inc.. It is a Class 2 Immunology device (product code DCF) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K961824 · Roche Diagnostic Systems, Inc. · Immunology device
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Jul 1996
Decision
74d
Days
Class 2
Risk

K961824 is an FDA 510(k) clearance for the COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5040 - the FDA immunology device 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K961824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date July 23, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 104d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DCF Albumin, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K961824.
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525 · Dade Behring, Inc. · Jan 2004
N ANTISERUM TO HUMAN ALBUMIN
K972929 · Behring Diagnostics, Inc. · Oct 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695 · Beckman Instruments, Inc. · Apr 1997
ALBUMIN TEST RID KIT
K914391 · The Binding Site, Ltd. · Dec 1991
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · Behring Diagnostics, Inc. · Jan 1990
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1989