Cleared Traditional

K961824 - COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN

K961824 is an FDA 510(k) clearance for COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K961824

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
31d faster than avg
Panel avg: 105d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

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 34
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