Cleared Traditional

K822291 - QUANTIMUNE HTSH IRMA

K822291 is the FDA 510(k) clearance for QUANTIMUNE HTSH IRMA by Bio-Rad. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K822291 · Bio-Rad · Chemistry device
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Aug 1982
Decision
25d
Days
Class 2
Risk

K822291 is an FDA 510(k) clearance for the QUANTIMUNE HTSH IRMA. 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 27, 1982 after a review of 25 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 Bio-Rad devices

Submission Details

510(k) Number K822291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1982
Decision Date August 27, 1982
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
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 145
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K822291.
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO
K823688 · Corning Medical & Scientific · Jan 1983
HISH EIA DIAGNOSTIC KIT
K822827 · Abbott Laboratories · Oct 1982
TAMDEM-R THYROID STIMULATING HORMONE KIT
K822705 · Hybritech, Inc. · Oct 1982
MICROMEDIC HTSH RIA KIT
K813645 · Micromedic Systems · Jan 1982
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY
K813525 · Micromedic Systems · Dec 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · Leeco Diagnostics, Inc. · Dec 1981