Cleared Traditional

K896867 - THYROID STIMULATING HORMONE-EIA-XT

K896867 is the FDA 510(k) clearance for THYROID STIMULATING HORMONE-EIA-XT by In Vitro Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K896867 · In Vitro Diagnostics, Inc. · Chemistry device
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Feb 1990
Decision
79d
Days
Class 2
Risk

K896867 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE-EIA-XT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by In Vitro Diagnostics, Inc. (Littleton, US). The FDA issued a Cleared decision on February 23, 1990 after a review of 79 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 In Vitro Diagnostics, Inc. devices

Submission Details

510(k) Number K896867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1989
Decision Date February 23, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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

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