Cleared Traditional

K780428 - ROCHE TSH RIA

K780428 is an FDA 510(k) clearance for ROCHE TSH RIA, manufactured by Hoffmann-La Roche, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K780428 · Hoffmann-La Roche, Inc. · Chemistry device
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Mar 1978
Decision
13d
Days
Class 2
Risk

K780428 is an FDA 510(k) clearance for the ROCHE TSH RIA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1978 after a review of 13 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 Hoffmann-La Roche, Inc. devices

FDA 510(k) Submission Details - K780428

510(k) Number K780428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1978
Decision Date March 30, 1978
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 200
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K780428.
THYRO-SHURE
K781296 · Nuclear Medical Laboratories, Inc. · Aug 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978
TSH RIA KIT
K780726 · Amersham Corp. · Jun 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · Pcl-Ria, Inc. · Feb 1978
THYROID STIMULATING HORMONE
K780015 · Pcl-Ria, Inc. · Feb 1978
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978