Cleared Traditional

K832258 - GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC

K832258 is an FDA 510(k) clearance for GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC, manufactured by Gelco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K832258 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
123d
Days
Class 2
Risk

K832258 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K832258

510(k) Number K832258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 31, 1983
Days to Decision 123 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
18d slower than avg
Panel avg: 105d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K832258.
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGG TEST
K841816 · Miles Laboratories, Inc. · Jun 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402 · Technicon Instruments Corp. · Jan 1984
FITC GOAT ANTI-HUMAN IGG Y CHAIN
K832264 · Gelco Diagnostics, Inc. · Oct 1983
TIA-IGG REAGENT & CALIBRATOR SETS
K831101 · Worthington Diagnostic Systems · Apr 1983
TITAN IMMUNO-FIX
K830594 · Helena Laboratories · Mar 1983
K832258 · GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
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