Cleared Traditional

K964695 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (...

K964695 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DCF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K964695 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
158d
Days
Class 2
Risk

K964695 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 29, 1997 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K964695

510(k) Number K964695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date April 29, 1997
Days to Decision 158 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 104d · This submission: 158d
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 28
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K964695.
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
K042643 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
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
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · Roche Diagnostic Systems, Inc. · Jul 1996
ALBUMIN TEST RID KIT
K914391 · The Binding Site, Ltd. · Dec 1991
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · Behring Diagnostics, Inc. · Jan 1990