Cleared Traditional

K951796 - CIBA CORNING ACS THYROID STIMULATING HO...

K951796 is an FDA 510(k) clearance for CIBA CORNING ACS THYROID STIMULATING HO..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K951796 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jun 1995
Decision
55d
Days
Class 2
Risk

K951796 is an FDA 510(k) clearance for the CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 55 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K951796

510(k) Number K951796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1995
Decision Date June 13, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

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 163
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K951796.
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · Bio-Rad Laboratories, Inc. · Nov 1995
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
K952211 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
AXSYM ULTRASENSITIVE HTSH II
K952148 · Abbott Laboratories · Jun 1995
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
K950921 · Nichols Institute Diagnostics · May 1995
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · Diagnostic Products Corp. · Mar 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994