Cleared Traditional

K841814 - OPTIMATE IGM TEST

K841814 is an FDA 510(k) clearance for OPTIMATE IGM TEST, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Immunology device with product code DFT cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K841814 · Miles Laboratories, Inc. · Immunology device
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Jun 1984
Decision
52d
Days
Class 2
Risk

K841814 is an FDA 510(k) clearance for the OPTIMATE IGM TEST. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 52 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 Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K841814

510(k) Number K841814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date June 22, 1984
Days to Decision 52 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
53d faster than avg
Panel avg: 105d · This submission: 52d
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 K841814.
TINA-QUANT(R) IGM
K862762 · Boehringer Mannheim Corp. · Sep 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
FIAX IGM TEST KIT
K831608 · Intl. Diagnostic Technology · Jun 1983
TIA-IGM REAGENT & CALIBRATOR SETS
K831103 · Worthington Diagnostic Systems · Apr 1983
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · Isolab, Inc. · Mar 1983