Cleared Traditional

K905486 - IMMUNOWELL TPO (MICROSOME) TEST

K905486 is an FDA 510(k) clearance for IMMUNOWELL TPO (MICROSOME) TEST, manufactured by General Biometrics, Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K905486 · General Biometrics, Inc. · Immunology device
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Jan 1991
Decision
28d
Days
Class 2
Risk

K905486 is an FDA 510(k) clearance for the IMMUNOWELL TPO (MICROSOME) TEST. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1991 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Biometrics, Inc. devices

FDA 510(k) Submission Details - K905486

510(k) Number K905486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date January 03, 1991
Days to Decision 28 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
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNL Device Classification - Class 2, Special Controls

Product Code JNL Immunochemical, Thyroglobulin 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 - JNL Immunochemical, Thyroglobulin Autoantibody

All 14
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K905486.
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · Cogent Diagnotics , Ltd. · Sep 1992
SYNELISA TPO ANTIBODIES
K921787 · Elias U.S.A., Inc. · Jul 1992
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · General Biometrics, Inc. · Oct 1990