Cleared Traditional

K890579 - TSH MICROASSAY

K890579 is the FDA 510(k) clearance for TSH MICROASSAY by Diamedix Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K890579 · Diamedix Corp. · Chemistry device

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Mar 1989

Decision

38d

Days

Class 2

Risk

K890579 is an FDA 510(k) clearance for the TSH MICROASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 38 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 Diamedix Corp. devices

Submission Details

510(k) Number	K890579 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 06, 1989
Decision Date	March 16, 1989
Days to Decision	38 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

50d faster than avg

Panel avg: 88d · This submission: 38d

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 125

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K890579.

AFFINITY(TM) HTSH(TM)

K897138 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990

MILENIA (TM) TSH

K900014 · Diagnostic Products Corp. · Jan 1990

COTUBE(TM) TSH IRMA

K890802 · Bio-Rad · Mar 1989

VENTREX COATED TUBE HIGH SENSITIVITY TSH

K885157 · Ventrex Laboratories, Inc. · Feb 1989

DELFIA(TM) NEONATAL HTSH KIT

K881627 · Pharmacia, Inc. · Oct 1988

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT

K882907 · Amersham Corp. · Sep 1988

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890579

Diamedix Corp.

Miami, FL · US

LIN, PH.D.

Regulatory profile

68 submissions 68 cleared

100% clearance rate · Active in Chemistry

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