Cleared Traditional

K910411 - MICROZYME TSH ENZYME IMMUNOASSAY KIT

K910411 is the FDA 510(k) clearance for MICROZYME TSH ENZYME IMMUNOASSAY KIT by Immunotech Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K910411 · Immunotech Corp. · Chemistry device
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Apr 1991
Decision
64d
Days
Class 2
Risk

K910411 is an FDA 510(k) clearance for the MICROZYME TSH ENZYME IMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 64 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 Immunotech Corp. devices

Submission Details

510(k) Number K910411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date April 03, 1991
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 K910411.
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