Cleared Traditional

K832257 - GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC

K832257 is an FDA 510(k) clearance for GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC, manufactured by Gelco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code CZN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K832257 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
120d
Days
Class 2
Risk

K832257 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC. Classified as Iga, Fitc, Antigen, Antiserum, Control (product code CZN), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 120 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 - K832257

510(k) Number K832257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 28, 1983
Days to Decision 120 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
15d slower than avg
Panel avg: 105d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZN Device Classification - Class 2, Special Controls

Product Code CZN Iga, Fitc, 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 - CZN Iga, Fitc, Antigen, Antiserum, Control

Devices cleared under the same product code (CZN) and FDA review panel - the closest regulatory comparables to K832257.
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · Kallestad Laboratories, Inc. · Feb 1986
OPTIMATE IGA TEST
K841815 · Miles Laboratories, Inc. · Jun 1984
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · Gelco Diagnostics, Inc. · Oct 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909 · Dako Corp. · Jul 1983
FIAX IGA TEST KIT
K831607 · Intl. Diagnostic Technology · Jun 1983
K832257 · GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
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