Cleared Traditional

K923401 - DELFIA HTSH ULTRA KIT

K923401 is the FDA 510(k) clearance for DELFIA HTSH ULTRA KIT by Wallac OY. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K923401 · Wallac OY · Chemistry device
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Nov 1992
Decision
143d
Days
Class 2
Risk

K923401 is an FDA 510(k) clearance for the DELFIA HTSH ULTRA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on November 30, 1992 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallac OY devices

Submission Details

510(k) Number K923401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date November 30, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
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 144
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K923401.
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · Sigma Chemical Co. · Aug 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · Bio-Rad · Jun 1993
ACCESS HTSH ASSAY
K925637 · Bio-Rad Laboratories, Inc. · Mar 1993
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
VISTA ULTRASENSITIVE HTSH ASSAY
K922138 · Syva Co. · Jul 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · Eastman Kodak Company · Jul 1992