Cleared Traditional

K012163 - POLYTITER SYSTEM

K012163 is an FDA 510(k) clearance for POLYTITER SYSTEM, manufactured by Polymedco, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K012163 · Polymedco, Inc. · Immunology device
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Aug 2001
Decision
40d
Days
Class 2
Risk

K012163 is an FDA 510(k) clearance for the POLYTITER SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Polymedco, Inc. devices

FDA 510(k) Submission Details - K012163

510(k) Number K012163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date August 20, 2001
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 105d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 67
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K012163.
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K983924 · Immuno Concepts, Inc. · Dec 1998