Cleared Traditional

QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (K896483) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896483 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Dec 1989
Decision
18d
Days
Class 2
Risk

K896483 is an FDA 510(k) clearance for the QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK. Classified as Alpha-2-macroglobulin, Antigen, Antiserum, Control (product code DEB), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5620 - 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K896483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date December 01, 1989
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5620
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 - DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control

All 12
Devices cleared under the same product code (DEB) and FDA review panel - the closest regulatory comparables to K896483.
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
K081249 · Dade Behring, Inc. · Jul 2008
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · Dade Behring, Inc. · Mar 2006
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · Beckman Instruments, Inc. · Feb 1998
HUMAN ALPHA2 MACROGLOBULIN
K791340 · Beckman Instruments, Inc. · Aug 1979