Cleared Traditional

K813525 - IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY

K813525 is the FDA 510(k) clearance for IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY by Micromedic Systems. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813525 · Micromedic Systems · Chemistry device

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Dec 1981

Decision

15d

Days

Class 2

Risk

K813525 is an FDA 510(k) clearance for the IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Micromedic Systems (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 15 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 Micromedic Systems devices

Submission Details

510(k) Number	K813525 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 1981
Decision Date	December 31, 1981
Days to Decision	15 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

73d faster than avg

Panel avg: 88d · This submission: 15d

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 156

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K813525.

TAMDEM-R THYROID STIMULATING HORMONE KIT

K822705 · Hybritech, Inc. · Oct 1982

QUANTIMUNE HTSH IRMA

K822291 · Bio-Rad · Aug 1982

MICROMEDIC HTSH RIA KIT

K813645 · Micromedic Systems · Jan 1982

RADIOIMMUNOASSAY FOR HUMAN THYROID

K813392 · Leeco Diagnostics, Inc. · Dec 1981

AMERLEX TSH RIA KIT

K812136 · Amersham Corp. · Aug 1981

TECHNICON STAR SYSTEM

K811431 · Technicon Instruments Corp. · Jun 1981

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 K813525

Micromedic Systems

Mchenry, IL · US

Regulatory profile

42 submissions 42 cleared

100% clearance rate · Active in Chemistry

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Sourced from FDA 510(k) public files . Updated monthly.

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