Cleared Traditional

K875165 - QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK

K875165 is the FDA 510(k) clearance for QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K875165 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Jan 1988
Decision
37d
Days
Class 2
Risk

K875165 is an FDA 510(k) clearance for the QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 K875165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1987
Decision Date January 22, 1988
Days to Decision 37 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
67d faster than avg
Panel avg: 104d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K875165.
PSA ANTIBODY KIT
K932326 · Ventana Medical Systems, Inc. · Aug 1993
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · Dako Corp. · Aug 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · Beckman Instruments, Inc. · Jun 1990
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · Kallestad Laboratories, Inc. · Feb 1986
QUANTIMETRIC PLUS SUPPORT PACK
K855013 · Kallestad Laboratories, Inc. · Feb 1986
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · Kallestad Laboratories, Inc. · Oct 1985