Cleared Traditional

K812611 - QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO

K812611 is the FDA 510(k) clearance for QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO by Kallestad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812611 · Kallestad Laboratories, Inc. · Chemistry device
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Oct 1981
Decision
17d
Days
Class 2
Risk

K812611 is an FDA 510(k) clearance for the QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K812611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date October 02, 1981
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

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