Cleared Traditional

K964843 - IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN...

K964843 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code JZH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K964843 · Beckman Instruments, Inc. · Immunology device
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Mar 1997
Decision
93d
Days
Class 2
Risk

K964843 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT. Classified as Factor B, Antigen, Antiserum, Control (product code JZH), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 6, 1997 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5320 - 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 - K964843

510(k) Number K964843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date March 06, 1997
Days to Decision 93 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
11d faster than avg
Panel avg: 104d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZH Device Classification - Class 2, Special Controls

Product Code JZH Factor B, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5320
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 - JZH Factor B, Antigen, Antiserum, Control

Devices cleared under the same product code (JZH) and FDA review panel - the closest regulatory comparables to K964843.
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
K882623 · Technicon Instruments Corp. · Jul 1988
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
K831959 · Kent Laboratories, Inc. · Jul 1983
KALLESTAD'S ENDOPLATE FACTOR B TEST
K811740 · Kallestad Laboratories, Inc. · Jul 1981
C3PA (GBG) PROPERDIN FACTOR B
K781016 · Icl Scientific · Aug 1978
LAS-R HUMAN C3 PROACTIVATOR TEST
K772084 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1978