Cleared Traditional

K791458 - AGGLUTINOTEST-THYROGLOBULIN

K791458 is the FDA 510(k) clearance for AGGLUTINOTEST-THYROGLOBULIN by Volu Sol Medical Industries. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K791458 · Volu Sol Medical Industries · Immunology device
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Dec 1979
Decision
147d
Days
Class 2
Risk

K791458 is an FDA 510(k) clearance for the AGGLUTINOTEST-THYROGLOBULIN. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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.

View all Volu Sol Medical Industries devices

Submission Details

510(k) Number K791458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date December 31, 1979
Days to Decision 147 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
43d slower than avg
Panel avg: 104d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 - JZO System, Test, Thyroid Autoantibody

All 40
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K791458.
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K881933 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1988
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · Miles Laboratories, Inc. · Feb 1987
CORDIA TG
K821489 · Cordis Corp. · Jun 1982
TEST, (IVDP) THYROID ANTIBODY
K760154 · Zeus Scientific, Inc. · Jul 1976