Cleared Traditional

K861362 - IMMUNOMEDICS SERUM ELISA TEST SYSTEM

K861362 is an FDA 510(k) clearance for IMMUNOMEDICS SERUM ELISA TEST SYSTEM, manufactured by Immunomedics, Inc.. The device is a Class 2 Immunology device with product code CZW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K861362 · Immunomedics, Inc. · Immunology device
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Jun 1986
Decision
57d
Days
Class 2
Risk

K861362 is an FDA 510(k) clearance for the IMMUNOMEDICS SERUM ELISA TEST SYSTEM. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Immunomedics, Inc. (Newark, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Immunomedics, Inc. devices

FDA 510(k) Submission Details - K861362

510(k) Number K861362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1986
Decision Date June 06, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 105d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZW Device Classification - Class 2, Special Controls

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 37
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K861362.
QM300 C3 ANTIBODY PACK
K871939 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987
PRECIMAT(R) C3
K871024 · Boehringer Mannheim Corp. · May 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · Dako Corp. · Apr 1987
RADIAL IMMUNODIFFUSION PLATES C3 & C4
K851286 · Cooper Biomedical, Inc. · Jun 1985
C3 ANTISERUM CONTROL
K834604 · Technicon Instruments Corp. · Jan 1984
RABBITT ANTISERUM TO HUMAN C3C
K831905 · Dako Corp. · Jul 1983