Cleared Traditional

K781170 - QUANTIMUNE HTSH IRMA HUMAN THYROID

K781170 is an FDA 510(k) clearance for QUANTIMUNE HTSH IRMA HUMAN THYROID, manufactured by Bio-Rad. The device is a Class 2 Immunology device with product code JLW cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K781170 · Bio-Rad · Immunology device
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Aug 1978
Decision
31d
Days
Class 2
Risk

K781170 is an FDA 510(k) clearance for the QUANTIMUNE HTSH IRMA HUMAN THYROID. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1690 - the FDA immunology device 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 Bio-Rad devices

FDA 510(k) Submission Details - K781170

510(k) Number K781170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date August 14, 1978
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 105d · This submission: 31d
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 Immunology devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 199
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K781170.
RIA KIT, IMMO PHASE
K781953 · Corning Medical & Scientific · Feb 1979
IMMO PHASE, THYROID HORMONE
K781409 · Corning Medical & Scientific · Sep 1978
THYRO-SHURE
K781296 · Nuclear Medical Laboratories, Inc. · Aug 1978
TSH RIA KIT
K780726 · Amersham Corp. · Jun 1978
ROCHE TSH RIA
K780428 · Hoffmann-La Roche, Inc. · Mar 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · Pcl-Ria, Inc. · Feb 1978