Cleared Traditional

K832265 - FITC GOAT ANTI-HUMAN IGM H CHAIN

K832265 is an FDA 510(k) clearance for FITC GOAT ANTI-HUMAN IGM H CHAIN, manufactured by Gelco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DFT cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K832265 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
123d
Days
Class 2
Risk

K832265 is an FDA 510(k) clearance for the FITC GOAT ANTI-HUMAN IGM H CHAIN. Classified as Igm, Antigen, Antiserum, Control (product code DFT), 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 866.5550 - 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: 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 - K832265

510(k) Number K832265 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.

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 29
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K832265.
GILFORD IMMUNOGLOBULIN M REAGENT
K853469 · Gilford · Sep 1985
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
GOAT ANTI-HUMAN IGM H CHAIN
K832259 · Gelco Diagnostics, Inc. · Oct 1983
FIAX IGM TEST KIT
K831608 · Intl. Diagnostic Technology · Jun 1983
TIA-IGM REAGENT & CALIBRATOR SETS
K831103 · Worthington Diagnostic Systems · Apr 1983
K832265 · FITC GOAT ANTI-HUMAN IGM H CHAIN
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