Cleared Traditional

K971834 - ANTI-THYROID PEROXIDASE (TPO) MICROPLAT...

K971834 is the FDA 510(k) clearance for ANTI-THYROID PEROXIDASE (TPO) MICROPLAT... by Monobind. It is a Class 2 Immunology device (product code JNL) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K971834 · Monobind · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
45d
Days
Class 2
Risk

K971834 is an FDA 510(k) clearance for the ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 45 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 Monobind devices

Submission Details

510(k) Number K971834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1997
Decision Date July 03, 1997
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 104d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K971834.
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · Hycor Biomedical, Inc. · Nov 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · Hycor Biomedical, Inc. · Nov 1996
AURAFLEX TG-AB AND TPO-AB
K951320 · Organon Teknika Corp. · Aug 1995