Cleared Traditional

K011082 - TPO IGG ANTIBODY EIA TEST

K011082 is an FDA 510(k) clearance for TPO IGG ANTIBODY EIA TEST, manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K011082 · Scimedx Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
57d
Days
Class 2
Risk

K011082 is an FDA 510(k) clearance for the TPO IGG ANTIBODY EIA TEST. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 57 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 Scimedx Corp. devices

FDA 510(k) Submission Details - K011082

510(k) Number K011082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2001
Decision Date June 06, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 105d · This submission: 57d
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 72
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K011082.
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · Axis-Shield Diagnostics, Ltd. · May 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · Axis-Shield Diagnostics, Ltd. · May 2002
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · Bayer Corp. · Oct 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · American Laboratory Products Co., Ltd. · May 2001
ALPCO MILENIA ANTI-TPO ELISA
K011201 · American Laboratory Products Co., Ltd. · May 2001
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K003291 · Bayer Diagnostics Corp. · Dec 2000