Cleared Traditional

K823053 - NML-TETRA-TUBE RIA

K823053 is an FDA 510(k) clearance for NML-TETRA-TUBE RIA, manufactured by Nuclear Medical Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K823053 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Nov 1982
Decision
23d
Days
Class 2
Risk

K823053 is an FDA 510(k) clearance for the NML-TETRA-TUBE RIA. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Nuclear Medical Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 10, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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.

FDA 510(k) Submission Details - K823053

510(k) Number K823053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date November 10, 1982
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 120
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K823053.
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · Diagnostic Products Corp. · May 1983
PHASE THYROXINE RADIOIMMUNOASSAY KIT
K830642 · Medical & Scientific Designs, Inc. · Apr 1983
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
K823004 · Bioclinical Group · Nov 1982
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K822399 · Leeco Diagnostics, Inc. · Sep 1982
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
K821554 · Amf Biological and Diagnostics Co. · Jun 1982
K823053 · NML-TETRA-TUBE RIA
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