Cleared Traditional

K873871 - IMMUNOGLOBULINS M

K873871 is an FDA 510(k) clearance for IMMUNOGLOBULINS M, manufactured by Unipath , Ltd.. The device is a Class 2 Immunology device with product code DFT cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K873871 · Unipath , Ltd. · Immunology device
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Oct 1987
Decision
50d
Days
Class 2
Risk

K873871 is an FDA 510(k) clearance for the IMMUNOGLOBULINS M. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on October 13, 1987 after a review of 50 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 Unipath , Ltd. devices

FDA 510(k) Submission Details - K873871

510(k) Number K873871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date October 13, 1987
Days to Decision 50 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
55d faster than avg
Panel avg: 105d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFT Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K873871.
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · Reagents Applications, Inc. · Aug 1989
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K884147 · Orion Diagnostica, Inc. · Oct 1988
WAKO(TM) IGM-HA DIRECT
K880828 · Wako Chemicals USA, Inc. · Mar 1988
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
TITAN GEL IMMUNOFIX CONTROLS
K871498 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGM
K862762 · Boehringer Mannheim Corp. · Sep 1986