Cleared Traditional

K881443 - LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUN...

K881443 is the FDA 510(k) clearance for LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUN... by London Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K881443 · London Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
52d
Days
Class 2
Risk

K881443 is an FDA 510(k) clearance for the LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by London Diagnostics, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - the FDA in vitro diagnostics and chemistry 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 London Diagnostics, Inc. devices

Submission Details

510(k) Number K881443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date May 27, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 Chemistry devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 146
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K881443.
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · Amersham Corp. · Sep 1988
VENTREX COATED TUBE TSH
K883342 · Ventrex Laboratories, Inc. · Sep 1988
REAGENTS FOR TSH ASSAY
K881381 · Sclavo, Inc. · Jul 1988
ABBOTT IMX HTSH
K880086 · Abbott Laboratories · Apr 1988
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · Medix Biotech, Inc. · Nov 1987
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K872305 · Diagnostic Products Corp. · Jul 1987