Cleared Traditional

K800167 - IMMUNOGLOBULIN M REAGENT SYSTEM

K800167 is the FDA 510(k) clearance for IMMUNOGLOBULIN M REAGENT SYSTEM by Calbiochem-Behring Corp.. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K800167 · Calbiochem-Behring Corp. · Immunology device
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Feb 1980
Decision
11d
Days
Class 2
Risk

K800167 is an FDA 510(k) clearance for the IMMUNOGLOBULIN M REAGENT SYSTEM. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1980 after a review of 11 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K800167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1980
Decision Date February 05, 1980
Days to Decision 11 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
93d faster than avg
Panel avg: 104d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, 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 - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K800167.
AIM SYSTEM (FOR IGM)
K811124 · Icl Scientific · May 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · Icl Scientific · Jan 1981
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · J.T. Baker Chemical Co. · Jun 1980
LANCER L-INA ANTI-IGM
K791402 · Sherwood Medical Co. · Oct 1979
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254 · Kallestad Laboratories, Inc. · Dec 1977
GOAT ANTISERUM IGM NEPHELOMHTRIC
K770963 · Kallestad Laboratories, Inc. · Jun 1977