Cleared Traditional

K982023 - PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT

K982023 is an FDA 510(k) clearance for PELICALSS HUMAN IGG SUBCLASS NEPHLOMETR..., manufactured by Inova Diagnostics, Inc.. The device is a Class 1 Immunology device with product code DAS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K982023 · Inova Diagnostics, Inc. · Immunology device
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Sep 1998
Decision
87d
Days
Class 1
Risk

K982023 is an FDA 510(k) clearance for the PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT. Classified as Igg (fc Fragment Specific), Antigen, Antiserum, Control (product code DAS), Class I - General Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5530 - 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.

FDA 510(k) Submission Details - K982023

510(k) Number K982023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1998
Decision Date September 04, 1998
Days to Decision 87 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
18d faster than avg
Panel avg: 105d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

DAS Device Classification - Class 1, General Controls

Product Code DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (DAS) and FDA review panel - the closest regulatory comparables to K982023.
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K982023 · PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
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