Cleared Traditional

K882082 - QM300 ALBUMIN ANTIBODY PACK

K882082 is an FDA 510(k) clearance for QM300 ALBUMIN ANTIBODY PACK, manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. The device is a Class 2 Immunology device with product code DCF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K882082 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Jul 1988
Decision
51d
Days
Class 2
Risk

K882082 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 July 8, 1988 after a review of 51 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

FDA 510(k) Submission Details - K882082

510(k) Number K882082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1988
Decision Date July 08, 1988
Days to Decision 51 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
54d faster than avg
Panel avg: 105d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K882082.
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808 · Technicon Instruments Corp. · Oct 1989
TECHNICON DPA-1(TM) SYSTEM
K882153 · Technicon Instruments Corp. · Aug 1988
QM300 CALIBRATOR D PACK
K881127 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
QM300 ALBUMIN ANTIBODY PACK
K881126 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
ALBUMIN IN SERUM
K873862 · Unipath , Ltd. · Oct 1987