Cleared Traditional

K921787 - SYNELISA TPO ANTIBODIES

K921787 is an FDA 510(k) clearance for SYNELISA TPO ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K921787 · Elias U.S.A., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
105d
Days
Class 2
Risk

K921787 is an FDA 510(k) clearance for the SYNELISA TPO ANTIBODIES. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 105 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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K921787

510(k) Number K921787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date July 28, 1992
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
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 15
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K921787.
AUTOSTAT II ANTI-TPO
K943580 · Cogent Diagnotics , Ltd. · Apr 1995
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · Cogent Diagnotics , Ltd. · Sep 1992
IMMUNOWELL TPO (MICROSOME) TEST
K905486 · General Biometrics, Inc. · Jan 1991
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · General Biometrics, Inc. · Oct 1990