Cleared Traditional

K881126 - QM300 ALBUMIN ANTIBODY PACK

K881126 is the FDA 510(k) clearance for QM300 ALBUMIN ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 2 Immunology device (product code DCF) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K881126 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Apr 1988
Decision
21d
Days
Class 2
Risk

K881126 is an FDA 510(k) clearance for the QM300 ALBUMIN ANTIBODY PACK. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on April 6, 1988 after a review of 21 days - a notably fast clearance 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: 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 K881126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1988
Decision Date April 06, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 104d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K881126.
TECHNICON DPA-1(TM) SYSTEM
K882153 · Technicon Instruments Corp. · Aug 1988
QM300 ALBUMIN ANTIBODY PACK
K882082 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988
QM300 CALIBRATOR D PACK
K881127 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
ALBUMIN IN SERUM
K873862 · Unipath , Ltd. · Oct 1987
ALBUMIN IN URINE
K873861 · Unipath , Ltd. · Oct 1987
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
K812496 · Dako Corp. · Sep 1981