Cleared Traditional

K890802 - COTUBE(TM) TSH IRMA

K890802 is the FDA 510(k) clearance for COTUBE(TM) TSH IRMA by Bio-Rad. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K890802 · Bio-Rad · Chemistry device
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Mar 1989
Decision
40d
Days
Class 2
Risk

K890802 is an FDA 510(k) clearance for the COTUBE(TM) TSH IRMA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on March 28, 1989 after a review of 40 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 Bio-Rad devices

Submission Details

510(k) Number K890802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1989
Decision Date March 28, 1989
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 143
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K890802.
ENZYMUN TEST(R) TSH-S
K900277 · Boehringer Mannheim Corp. · Apr 1990
AFFINITY(TM) HTSH(TM)
K897138 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MILENIA (TM) TSH
K900014 · Diagnostic Products Corp. · Jan 1990
TSH MICROASSAY
K890579 · Diamedix Corp. · Mar 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · Ventrex Laboratories, Inc. · Feb 1989
DELFIA(TM) NEONATAL HTSH KIT
K881627 · Pharmacia, Inc. · Oct 1988