Cleared Traditional

K841816 - OPTIMATE IGG TEST

K841816 is the FDA 510(k) clearance for OPTIMATE IGG TEST by Miles Laboratories, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K841816 · Miles Laboratories, Inc. · Immunology device
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Jun 1984
Decision
52d
Days
Class 2
Risk

K841816 is an FDA 510(k) clearance for the OPTIMATE IGG TEST. Classified as Igg, Antigen, Antiserum, Control (product code DEW), 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 866.5510 - 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

Submission Details

510(k) Number K841816 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
52d faster than avg
Panel avg: 104d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K841816.
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · Coulter Electronics, Inc. · Jul 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · Abbott Laboratories · Jul 1985
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402 · Technicon Instruments Corp. · Jan 1984
TITAN IMMUNO-FIX
K830594 · Helena Laboratories · Mar 1983
DAKO PAP KIT K505
K812484 · Dako Corp. · Feb 1982