Cleared Traditional

K963286 - IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOB...

K963286 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOB..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DAD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K963286 · Beckman Instruments, Inc. · Immunology device
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Oct 1996
Decision
47d
Days
Class 2
Risk

K963286 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT. Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5460 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K963286

510(k) Number K963286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date October 07, 1996
Days to Decision 47 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
57d faster than avg
Panel avg: 104d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAD Device Classification - Class 2, Special Controls

Product Code DAD Haptoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5460
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 - DAD Haptoglobin, Antigen, Antiserum, Control

All 12
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K963286.
K-ASSAY HAPTOGLOBIN
K993480 · Kamiya Biomedical Co. · Nov 1999
TINA-QUANT HAPTOGLOBIN
K972639 · Boehringer Mannheim Corp. · Jan 1998
N-ASSAY TIA MULTI V-NL
K964301 · Crestat Diagnostics, Inc. · Jul 1997
N/T PROTEIN CONTROL SY/L, M AND H
K952593 · Behring Diagnostics, Inc. · Jul 1995
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829 · Instrumentation Laboratory CO · Jul 1992
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · Reagents Applications, Inc. · May 1991