Cleared Traditional

K791458 - AGGLUTINOTEST-THYROGLOBULIN

K791458 is an FDA 510(k) clearance for AGGLUTINOTEST-THYROGLOBULIN, manufactured by Volu Sol Medical Industries. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K791458

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
42d slower than avg
Panel avg: 105d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

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 71
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